How to Create a Research Protocol

The Research Protocol is a statement of the researcher's project design and a description of

his/her responsibilities toward the human subjects involved in the research.

To ensure an effective review by the Institutional Review Board, a full description of the planned

research must be submitted with the Application for IRB Review. A research protocol provides

the reader with background information of the problem under study, including the study

rationale, a detailed plan for conducting the research involving human research participants, and

a discussion of the potential importance of the research.

1. Objectives

The purpose of the study (research questions and / or study objectives) should be clearly and

succinctly stated. In experimental designs, objectives may be stated as hypotheses to be tested.

2. Background and Rationale

Summarize and synthesize the available research (including published data) to provide

justification for the study. Evaluate prior research for relevance to the research question under

study. Describe the significance of the research including potential benefits for individual

subjects or society at large.

3. Procedures

The procedures should include the following:

a) Research Design

The research design should be identified and should be appropriate to answer the research

question(s) under study. Describe the type of research proposed (e.g. experimental, correlational,

survey, qualitative) and specific study design that will be used.

b) Sample

Describe the sampling approach to be used. Identify the procedures that will be used to recruit,

screen, and follow study volunteers. Specifically define the study sample (number of subjects to

be enrolled, characteristics of subjects to be included in and excluded from the research, and

whether this will be a random or convenience sample).

c) Measurement/Instrumentation

Identify the variables of interest and study endpoints (where applicable). Justify measurement

techniques selected. Provide information regarding the validity and reliability of selected

measures.

d) Detailed study procedures

Methods for collecting data and for avoiding / minimizing subject risks should be included.

Include a timeline for subject participation in the project. Identify how subject confidentiality

will be safeguarded (plans for coding data and for securing written and electronic subject

records). Indicate how long personal information will be stored once the study is completed.

Methods will vary with the research approach used (qualitative, quantitative). The selected

methods should be sufficiently described to justify the use of the approach for answering the

defined research question. Methods should also be described in adequate detail so that IRB

members may assess the potential study risks and benefits.

e) Internal Validity

Threats to internal / external validity should be considered. Describe measures that have been

taken to avoid study bias.

f) Data Analysis

Specify the analytic techniques the researcher will use to answer the study questions. Indicate the

statistical procedures (e.g. specific descriptive or inferential tests) that will be used and why the

procedures are appropriate. For qualitative data, specify the proposed analytic approaches.

4. Bibliography

Include a reference list of literature cited to support the protocol statement.

What does literature reports about anti-inflammatory, anti-oxidant dietary approaches to mitigate fibromyalgia symptoms? A literature Review

Lorraine M. Justiniano, RDN, MS Candidate

FDNT 680 – Research Seminar

Dr. Anjejo

Andrews University

April 24, 2020

1

INtroduction

2

Fibromyalgia

Chronic Neurological Disease that amplifies pain perception throughout all body muscles (ACR, 2019).

3

Fibromyalgia

4

Severe Pain Sensitivity

Chronic Fatigue

Headaches

Anxiety

Memory/Concentration

Sleeping disorders

Inflexibility (especially in the morning)

Epidemiology

Between 4 to 5 millions of US adults.

Women

Middle age

75% to 90% of all cases

Symptoms: more prominent or intensified

(CDC, 2017; NFA, n.d. & Weird et. Al. 2006)

5

Risk Factors

6

Traumatic Events (Physical and/or Mental)

Family History (8x greater)

Virus infections

Obesity

Lupus

Rheumatoid Arthritis

* Irritable Bowel Syndrome (IBS) & Non-Celiac Gluten Sensitivity co-exist with FM.

*70% of FM patients reports IBS symptoms.

etiology

7

Premature aging of nervous system

Brain’s Chemical Defect (Neurotransmitters)

Hormonal Imbalances

Inability of the body to detoxify appropriately

Treatment

Conventional Treatment

Pain Killers

Alternative Treatments

Aerobic exercise

Yoga

Tai Chi Martial Arts

Stress Management with

Cognitive Behavior Therapy

Acupuncture

Chiropractic / Physical Therapy

Massages

Nutritional Therapy

Lightly Studied

No official treatment

Could play a key role

8

Aim of literature review

To discuss what studies show about anti-inflammatory/anti-oxidant dietary approaches, including supplementation, on Fibromyalgia symptoms in women.

rationale

FM has been strongly linked with:

High Levels of Oxidative Stress & Weak Antioxidant Capacity.

Nutritional Deficiencies.

Mostly plant-based diets have been linked with less oxidative stress, due to high intake of anti-inflammatory & antioxidant food sources.

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Methodology

10

Search Strategy

Search dates Research Engines Target Population Study Designs Inclusion Criteria Exclusion Criteria
October 2019 – April 2020. Ebscohost, PubMed, Deep Dyve, Google Scholar. Adult women diagnosed with FM. Experimental or Quasi Experimental, Crossover & Clinical Trial. Peer-Reviewed Human Studies. Observational studies Systematic or Meta-analysis reviews Subjects requiring specific nutritional interventions. Pregnant women Breastfeeding women

11

Table: characteristics of the included studies

12

Results

13

Vegetarian/Vegan Diets

Significant decrease in musculoskeletal pain. As consequence, participants also improved quality of life (p = 0.005).

Some of them reported significant decrease/improvement in general health (p = 0.02), stiffness (p = 0.0001) and sleep (p = 0.0001).

However, Martínez-Rodríguez, et. al. (2017) reached statistical significance only when vegetarian diet was followed along with core exercise. The control group following a vegetarian diet with no exercise didn’t experience changes in symptoms.

14

Igubac diet/fodmap diet inflammatory gut-brain axis control diet

The use of FODMAP diet by itself reached significant decrease (p < 0.01) in all FM symptoms including musculoskeletal pain, muscle tension and gastrointestinal symptoms.

IGUBAC Diet intervention mostly showed a non-significant tendency to improve FM symptoms such as pain and fatigue. It reached significant decrease in Pain Catastrophizing (p = 0.011) and pain intensity (p < 0.05).

15

supplementation

Modified Myer’s-Formula (intravenous nutrient therapy) promoted a significant decrease in pain and fatigue (p = 0.005). Energy level was increased. No dietary intervention (usual diet was not described).

Supplementation with olive oil showed some improvement in Pain Catastrophizing questionnaire and Fatigue Severity Scale, both not significant.

Turmeric supplement ( + IGUBAC diet) showed a moderate change for Fatigue Severity Scale. Statistical significance for pain intensity (p < 0.05)

16

What other reviews say?

A healthy diet in conjunction with other interventions might represent a decrease in fatigue and/or pain symptoms, improving quality of life. However, they couldn’t establish a solid diet – FM association due to the lack of rigorous studies (da Silva, A.F., et.al., 2017).

Mitigation of FM symptoms can be reach on patients adopting a diet rich in antioxidants and when excitotoxin substances such as MSG and aspartame are eliminated from diet (Rossi, A. et.al., 2015 & Firestone, K., et. al., 2012).

17

mechanisms

18

Weight

Vegetarian/vegan diets tend to promote weight loss (levels of pro-inflammatory cytokines & CRP ↓.

Increase

Increase

Increase intake of antioxidants; decrease Reactive Oxygen Species (ROS); Mitochondrial functioning improvement; More ATP for muscle & neural cells; Less Pain.

Supplementation

Supplementation with phytochemical-rich medical food (targeting nutrients that FM patients tend to lack) will support the expression of Metallothionein mRNA, promoting the binding function of this protein with toxic elements such as Mercury, Cadmiun, Lead, Arsenic. As consequence; decrease in ROS.

Increase intake of antioxidants; decrease the production of FREE SUPEROXIDE RADICALS. In turn, synthesis of TNF-ALFA & IL-BETA (cytokines involved in inflammatory pain) will be interrupted.

mechanisms

19

Decrease

Decrease lipid peroxidation by antioxidant/anti-inflammatory components will decrease phospholipids damage in cell membranes of the brain; less alteration to neurotransmitters system; improve in depressive symptoms. Less ROS, less inflammatory cytokines. (For instance: olives)

Support

Increase in Vit. B complex and Vit. C; support production of neurotransmitters responsible for changing pain perception.

Limit

Limit processed food intake; limit the intake of excitatory neurotransmitters such as MSG & Aspartame; less neurotoxicity; mitigation of FM symptoms.

Pain and discomfort

The use of low FODMAP Diet decrease bacterial fermentation; less pain and discomfort.

Strengths & limitations

Strength

Results could be generalized to all women with FM that otherwise are not suffering from other serious chronic disease or allergies.

Limitations

All studies had very small samples.

Short period of intervention.

Many studies lack control group.

Lack of more recent & rigorous studies.

20

Conclusions

21

Overall findings & Public health implications

Dietary interventions focusing on anti-inflammatory and anti-oxidant rich food and the elimination of pro-inflammatory/oxidant substances, may have the potential to ease FM symptoms and to deliver a better quality of life to women suffering from FM.

Its effects can even be more pronounce when use along with other medical and non-medical approaches according to individual needs.

Long-term RCT studies are deeply needed and encourage to be able to develop an official nutritional intervention.

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references

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Vegetarianism and Prevalence of Mental Health Disorders in Adults

Amara Sims

FDNT 680

Dr. Dixon Anjejo

April 28, 2020

Table of Contents

Abstract 3

Background and Rationale 4

Methods 5

Search strategies 5

Study selection 5

Data extraction 5

Results 6

Description of studies 6

Self-perceived mental health 7

Prevalence of mental health disorders 8

Motivators of a vegetarian dietary pattern 9

Discussion 10

Potential mechanisms 11

Strengths and limitations 12

Conclusion and Implications 13

Appendix A 14

Appendix B 15

Bibliography 19

Abstract

Background: Mental health disorders are becoming one of the leading causes of disability worldwide. Adopting a plant-based diet has been an effective lifestyle approach to preventing noncommunicable diseases, including cardiovascular disease and some cancers. Only 36.9% of individuals diagnosed with mental health disorders receive treatment, thus an intervention involving diet may be more feasible at a population level to reduce the risk of depression, and mood and anxiety disorders.

Objective: A systematic review to summarize the association between following a vegetarian diet by habitual intake or intervention and the measures of self-perceived mental health or the prevalence of mental health disorders.

Exposure and Outcome: The exposure was following a vegetarian diet by habitual intake or intervention; while self-perceived mental health and the prevalence of mental health disorders are the outcomes.

Methods: Articles were selected from several peer-reviewed databases (Google Scholar, EBSCO, PubMed, SAGE Journals, ScienceDirect/Elsevier, Web of Science, Oxford Academic, Wiley Online Library) and subsequent reference lists were also scoured. Advanced search tools were used to narrow down the results, including keywords such as “vegetarian,” “vegetarianism,” “mental health,” “depression,” and “anxiety.” Studies were eligible whether they detailed human observational and intervention studies over the past 10 years that clearly defined the dietary patterns. Studies were excluded if they were an animal study or human cell line study or failed to measure self-perceived mental health or the prevalence of mental health disorders.

Results: 118 articles were identified from the peer-reviewed databases and 17 from reference lists. 120 articles were excluded due to being duplicates, or after screening the titles, abstracts, keywords, and full-text. Overall, there is evidence that shows following a vegetarian diet with the right motivators is associated with a decrease in the risk of mental health disorders by 26-35%.

Conclusion and Implications: The results of this review have built upon evidence in the literature that investigates the potential of vegetarian diets in mediating the risk of mental health disorders and could direct health promotion and policy changes. This systematic review reflects on and supports the present knowledge in literature which includes contrary evidence. Thus, there still exists a need for future research to ultimately determine the role of a vegetarian dietary pattern in the prevention of mental health disorders.

Background and Rationale

Mental health disorders are becoming one of the leading causes of disability worldwide. In the United States, almost 1 in 5 adults will experience depression or have an anxiety disorder annually; unfortunately, only 36.9% of those 40 million individuals will seek treatment, such as cognitive-behavioural therapy and pharmacological intervention (Anxiety and Depression Association of America, 2020) because of social stigma, accessibility, or lack of knowledge or awareness. Women carry a heavier burden compared to their male counterparts, being twice as likely to be affected by symptoms of these disorders (Anxiety and Depression Association of America, 2020). The risk factors include personality, life events, gender, age, life events, and family or genetic history (Anxiety and Depression Association of America, 2020).

Preventing the prevalence of chronic mental health disorders at the population level is the most ideal approach, especially if these chronic conditions can be addressed by lifestyle changes, including diet. A plant-based diet has shown many benefits for other noncommunicable diseases, including cardiovascular disease and some cancer types (Craig, et al., 2018). Studies investigating the impact of vegetarian diets on mental health disorders have provided conflicting results, but the evidence should be revisited. This systematic review will compile this research conducted over the past ten years, while also summarizing the mechanisms that affect the risk of mental health disorders. The aim of this study is to summarize the association between following a vegetarian diet by habitual intake or intervention as the exposure or independent variable and the measures of self-perceived mental health or the prevalence of mental health disorders as the outcome.

Methods

Search strategies

The database searches were conducted in early February 2020. Articles were selected from several peer-reviewed databases (Google Scholar, EBSCO, PubMed, SAGE Journals, ScienceDirect/Elsevier, Web of Science, Oxford Academic, Wiley Online Library) and subsequent reference lists were also scoured. Advanced search tools were used to narrow down the results, including keywords such as “vegetarian,” “vegetarianism,” “mental health,” “depression,” and “anxiety.”

Study selection

Articles were screened for relevance based on title, abstract, and then the full content of the article. The following criteria were used to include relevant studies for this systematic review: (i) observational and intervention human studies across a variety of cultures; (ii) published within the past ten years; and (iii) clearly defined the dietary patterns studied. Articles were excluded if they (i) were an animal study or human cell line study, or (ii) did not measure self-perceived mental health or prevalence of mental health disorders. Figure 1 (Appendix A) outlines the identification, screening, eligibility, and inclusion processes that refined a final literature sample of fifteen studies.

Data extraction

Each study was analyzed based on the number of participants and their demographics. Dietary patterns were clearly defined and re-organized for ease of comparison. Exposure to a vegetarian diet through habitual intake or intervention were compared, as well the outcome of mental health disorders, as indicated by verified self-perceived health measures (e.g. Depression and Anxiety Stress Score (DASS) or Profile of Mood States (POMS)) or by the prevalence of mental health disorders. Authors were not contacted to discuss missing data.

Results

Description of studies

In total, 118 articles were identified from the peer-reviewed databases and seventeen from reference lists. However, after removing duplicates, 104 articles remained. An additional 42 articles were excluded after screening the titles, abstracts, and keywords. Sixty-two full-text articles were assessed and 47 were excluded on the basis that they were published over 10 years or did not clearly define the dietary plans. This process has been chronicled in Figure 1 (Appendix A). Therefore, fifteen studies were included in this systematic review, including two randomized controlled trials, nine cross-sectional studies, three cohort studies, and one case-control study. There was no artificial inflation of sample size since the participants from the studies did not overlap. Tables 1 and 2 (Appendix B) outlines the characteristics of these studies, including study designs, main objectives, exposures, measured outcomes, main findings, rationale or mechanisms, study limitations and gaps, and research recommendations from those eligible articles. The collection of study sample sizes ranged from 35 to 90 380 participants, aged 15 to 84 years old, in North America, Europe, China, Iran, and Australia. Overall, there is evidence that shows following a vegetarian diet with the right motivators is associated with a decrease in the risk of mental health disorders by 26-35%.

Self-perceived mental health

Nine studies employed a self-perceived mental health questionnaire to mental health while seeking to determine the difference between vegetarian and omnivore dietary patterns. The DASS was used by four studies, the POMS was used twice, in addition to the post-traumatic stress diagnostic scale (PDS) and SF-36. In a small study of 138 participants, vegetarian fatty-acid intake was not shown to negatively affect the mood; in fact, vegetarians had significantly lower DASS scores (8.32; p < 0.001) and POMS scores (0.10; p = 0.007) compared to omnivores; concluding that low EPA, DHA, and arachidonic acid (AA) intakes, and high intakes of ALA and LA, were associated with better mood ( p < 0.05; Beezhold et al., 2010). By restricting meat consumption, and thus, lowering AA intake, in a small study of 39 participants, Beezhold & Johnston (2012) reinforced the protective effect of vegetarianism on DASS ( p = 0.045), and later in 2014, Beezhold and colleagues studied a group of 620 participants, concluding that both age and veganism were significantly inversely associated with DASS scores ( p < 0.05 and p < 0.001, respectively); vegetarian and vegan males were associated with lower anxiety compared to omnivores (vegetarian: p = 0.022, CI95 = -0.401– -5.140; vegan: p = 0.002, CI95 = -1.03– -4.56); and vegan females were linked to significant lower stress scores compared to control ( p = 0.007; CI95 = -0.56– -3.51).

These gender results were also noted in a study of 3 846 adults by Hosseinzadeh et al. (2016): female vegetarians were 35% less likely to have depression (CI95 = 0.46–0.91); females following the traditional Iranian diet were 42% more likely to have depression (CI95 = 1.01–1.99) and 56% more likely to have anxiety (CI95 = 1.00–2.42); while male following the Western diet are 73% more likely to have depression (CI95 = 1.07–2.81). A close investigation of 74 participants who were randomly assigned to a vegetarian diet (60% carbohydrates, 15% protein, 25% fat) or the control diet (50% carbohydrates, 20% protein, 30% fat) showed a significant decrease in Beck depression scores after 24 weeks in the vegetarian cohort ( p < 0.001; Kahleova et al., 2013).

However, other studies showed the opposite evidence. The largest study in this review ( N = 90 380) found that depressive symptoms were 43% more likely in pesco-vegetarians (CI95 = 1.19–1.72) and 36% more likely in and lacto-ovo-vegetarians (CI95 = 1.09–1.70; Matta et al., 2018); as well as Burkert and colleagues (2014), who found, in a sample of 15 474 participants, a significantly higher prevalence of mental illnesses (including anxiety disorder and depression) in the vegetarian cohort compared to the carnivore cohorts ( p = 0.036). A similarly sized study, of 15 396 participants, showed that vegetarians in both European and Asian populations had lower positive mental health and more mental health problems ( p < .001; Velten et al., 2018). Lastly, vegetarians were associated with a higher PDS score of 7.4 compared to the control group ( p = 0.042), as well as a lower SF-36 score of 45.6 compared to the control ( p = 0.008) in a study on 1 254 Swiss adults (Schreiner et al., 2019).

Prevalence of mental health disorders

Three studies utilized the diagnosis of a mental health disorder as the outcome measure. A study of 4 181 German adults ranging from ages 18 to 79 found that vegetarians were 77% more likely to suffer from lifetime anxiety disorders than non-vegetarian counterparts (CI95 = 1.12–2.79) and 75% more likely to suffer from unipolar depressive disorders after 1 year (CI95 = 1.03–2.99; Michalak et al., 2012). A study of 9 905 adults in Finland showed an interesting relationship between seasonal affective disorder (SAD) patients and vegetarianism: SAD patients were 3.9 times more likely to be vegetarian ( p = 0.000, CI95 = 1.84–8.45), and vegetarians were 3.9 times more likely to have SAD ( p = 0.000, CI95 = 1.81–8.36; Meesters et al., 2016).

However, the comparison of three dietary patterns (Mediterranean, pro-vegetarian dietary pattern, Spanish government recommendations) of 15 093 participants showed a significant effect on depression: following a vegetarian dietary pattern reduced the risk of depression by 26% (CI95 = 0.61–0.89; Sánchez-Villegas et al., 2015).

Motivators of a vegetarian dietary pattern

Three studies took special consideration of the motivators that led to adopting a vegetarian dietary pattern. Hessler-Kaufmann and colleagues (2020) found a significant relationship effect between 3 groups ( N = 511) and Düsseldorf Orthorexia Scale (DOS) scores when predicting depression scores ( p = 0.01); noting that semi-vegetarians with high DOS score associated with higher depression scores ( p = 0.002) than omnivores or vegetarians. Nonetheless, two studies showed higher rates of depression in vegetarian cohorts due to motivators: the Lavallee et al. (2019) study ( N = 22 417) showed no relationship between vegetarian and control cohorts in the US, Germany, and Russia; but higher prevalence of depression among Chinese vegetarian students (R2 = 0.087; p < 0.001); and the Forestell et al. (2018) cross-sectional study of 6450 participants found vegetarians to be significantly more depressed than omnivores ( p < 0.001), although no significance between the vegetarian and semi-vegetarian cohorts ( p = 0.155).

Discussion

The studies included in this systematic review had mixed conclusions on the effectiveness of a vegetarian diet as an intervention for preventing mental health disorders. Five studies showed a significant ( p < 0.045) protective impact of a vegetarian diet on self-perceived mental health (Beezhold & Johnston, 2012); (Beezhold, Johnston, & Daigle, 2010); (Beezhold, Radnitz, Rinne, & DiMatteo, 2014); (Kahleova, Hrachovinova, Hill, & Pelikanova, 2013); (Hosseinzadeh, et al., 2016); one study showed a significant (CI95 0.61 – 0.89) decrease in the prevalence of mental health disorders (Sánchez-Villegas, et al., 2015); and another study showed the significant (p = 0.002) protective effects due to motivation (Hessler-Kaufmann, et al., 2020). However, five studies showed a significant ( p < 0.046) negative association between a vegetarian diet and self-perceived mental health (Matta, et al., 2018); (Burkert, Muckenhuber, Goßschädl, Rásky, & Freidl, 2014); (Velten, Bieda, Scholten, Wannemüller, & Margraf, 2018); (Schreiner, et al., 2019); two studies showed a significant (CI95 < 1.81) increase in the prevalence of mental health disorders (Michalak, Zhang, & Jacobi, 2012) (Meesters, et al., 2016); and still two others show a negative effect ( p < 0.001) of motivating factors on depression (Lavallee, Zhang, Michelak, Schneider, & Margraf, 2019); (Forestell & Nezlek, 2018).

This review supports the current contrary evidence available in the literature. The most recent study by Dobersek et al. (2020) investigated the association between abstaining from meat or restricting meat consumption and depression and anxiety. The authors similarly presented both positive and negative evidence due to a variety of methodologies used in the studies, as well as limited interpretations and significance (Dobersek, et al., 2020). The temporal association between the onset of depressive symptoms and the adoption of dietary patterns was also addressed, as well as noting that causality could not be determined, as a result of limited study designs (Dobersek, et al., 2020). As a result, the conclusion proposed that restricting meat consumption is not a strategy to improve mental health (Dobersek, et al., 2020).

Potential mechanisms

Psychological disorders may lead to adopting vegetarianism (Forestell & Nezlek, 2018). Thus, it is possible that depressed individuals may try to improve their wellbeing by adopting vegetarian dietary habits (Forestell & Nezlek, 2018); (Michalak, Zhang, & Jacobi, 2012); (Schreiner, et al., 2019).

The reduced amount of arachidonic acid in the diet by restricting meat consumption is able to affect the mood (Beezhold, Johnston, & Daigle, 2010), as well as an increased intake of polyunsaturated fatty acids, such as omega-3 fatty acids (Beezhold & Johnston, 2012) found in many nuts and seeds, affects the mood through the serotonin pathway (Beezhold, Johnston, & Daigle, 2010). In addition, the vegetarian diet alters neurotransmitter synthesis and receptor dynamics, thus increasing voluntary control over food intake (Kahleova et al., 2013). The individual may be satisfied with the type and amount of food consumed, thus indirectly maintaining BMI and reducing the risk of obesity. By reducing the consumption of animal products, especially found in processed food, and increasing the consumption of fruits and vegetables (antioxidant load), the risk of inflammation is reduced and the individual gains the ability to cope with stress and anxiety (Beezhold, et al., 2014; Hosseinzadeh, et al., 2016).

However, not all studies showcased the protective effect of vegetarian diets. Due to nutritional deficiency, including iron, calcium, zinc, vitamin B12, vitamin D, or some omega-3 fatty acids, the risk of mental health disorders is higher among vegetarians (Matta, et al., 2018). Finally, if the motivators to adopt a vegetarian dietary pattern are not strong, there may be dissonance between ideals and behaviour that leads to an increased risk of mental health disorders. Such motivations may include orthorexic tendencies (Hessler-Kaufmann, et al., 2020), or economic reasons (Lavalee et al., 2019).

Strengths and limitations

A strength of this systematic review is that a variety of cultures have been included to improve generalizability. In addition, a variety of dietary patterns were studied to showcase the varying degrees of antidepressive effects; however, this is also a limitation since not all participants entered with the same baseline diet.

Although random grouping ensures validity and generalizability, some of the studies had small sample sizes, which may reduce the generalizability of results. Many study designs did not plan any follow-up beyond two years to explore long term effects. The studies may have also been exposed to selection bias since participants with a higher vegetable intake are often associated with higher socioeconomic status, higher education, household income, and physical activity; as well as social desirability, wherein the participants responded to the surveys and questionnaires to impress the researchers.

Overall, a majority of the studies included had a cross-sectional design; this limits the ability to determine causality – whether the diet type caused the depressive symptoms, or the depressive symptoms influenced the diet choice (Matta, et al., 2018).

Conclusion and Implications

The results of this review have built upon evidence in the literature that investigates the potential of vegetarian diets in mediating the risk of mental health disorders. Nonetheless, the results of this review could direct health promotion and policy changes, particularly regarding the dietary recommendations for individuals at risk for mental health disorders and to address risk factors by adopting coping strategies. This systematic review reflects on and supports the present knowledge in literature which includes contrary evidence. Thus, there still exists a need for future research to ultimately determine the role of a vegetarian dietary pattern in the prevention of mental health disorders.

Appendix A

Figure 1: Flowchart outlining the protocol adopted in this systematic review based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Four-Phase Flow Diagram (Moher, Liberati, Tetzlaff, & Altman, 2009).

Records identified through electronic database searching ( n = 118 )

Screening

Included

Eligibility

Identification

Additional records identified through reference lists ( n = 17 )

Records after duplicates removed ( n = 104 )

Articles with titles, abstracts, and keywords screened ( n = 62 )

Records excluded ( n = 42 )

(>10 year publication date, no clearly defined dietary patterns)

Full-text articles assessed for eligibility ( n = 15 )

Full-text articles excluded ( n = 47 )

(>10 year publication date, no clearly defined dietary patterns)

Final literature sample ( n = 15 )

Appendix B

Table 1: Characteristics of the included studies, organized by year

Source

Duration

Country

Total Participants*

Age (years)

Dietary Pattern

Beezhold et al., 2010

USA

138

Beezhold et al., 2012

2 weeks

USA

39

Omnivore, pesco-vegetarian, vegetarian

Michalak et al., 2012

Germany

4 181

18 – 79

Vegetarian

Kahleova et al., 2013

24 weeks

USA

74

60% carbohydrates, 15% protein, 25% fat

Beezhold et al., 2014

USA

620

25 – 60

Vegan, vegetarian, omnivore

Burket et al., 2014

Austria

15 474

> 15

Vegetarian, carnivore rich in fruits and vegetables, carnivore less in fruits and vegetables, carnivores rich in meat

Hosseinzadeh et al., 2016

3 – 4 weeks

Iran

3 846

20 – 55

Lacto-ovo vegetarian, fast-food, traditional, Western

Sánchez-Villegas et al., 2015

Spain

15 093

Mediterranean, pro-vegetarian dietary pattern, AHEI-2010

Meesters et al., 2016

Finland

9 905

25 – 74

Forestell et al., 2018

USA

6 450

Vegan, lacto-vegetarian, lacto-ovo vegetarian, pesco-vegetarian, semi-vegetarian, occasional omnivore, omnivore

Matta et al., 2018

France

90 380

18 – 69

Omnivore, pesco-vegetarian, lacto-ovo vegetarian, vegan

Velten et al., 2018

Germany, China

15 396

15 – 65

Vegetarian

Lavallee et al., 2019

Germany, China, Russia, USA

22 417

Schreiner et al., 2019

Switzerland

1 254

Hessler-Kaufmann et al., 2020

Germany

511

18 – 84

Vegetarian, semi-vegetarian, omnivore

*Number of participants who completed all trials.

Sims, 2

Table 2: Characteristics of Included Studies

Authors

(year)

Study design

Main Objective

Exposure

Outcomes Measured

Main Findings

Rationale / Mechanisms

Study Limitations and Gaps

Research Recommend-ations

Self-perceived health

Beezhold et al., 2010

Cross-sectional study

To determine the difference and association between vegetarian and omnivore dietary patterns on mood

n-3 fatty acids

DASS; POMS

VEG DASS scores lower than OMN ( p < 0.001); VEG POMS scores lower than OMN ( p = 0.007)

Higher consumption of PUFA, lower consumption of AA

No blood lipid or inflammatory marker measurements; selection bias; social desirability; not generalizable

Explore the use of a dietary fat modification intervention to improve mood

Beezhold et al., 2012

Randomized-controlled trial

To determine the relationship between restricting meat and mood

Meat intake

DASS; POMS

Vegetarian has lower DASS ( p = 0.045)

Modulation of mood by inflammation and n-3/n-6 FAs

Small sample; short duration; weight fluctuation

Large sample; longer duration; manage BMI

Kahleova et al., 2013

Randomized-controlled trial

To determine the association between a vegetarian diet and psychological traits

Veg: 60% carbs, 15% protein, 25% fat

Control: 50% carbs, 20% protein, 30% fat

Quality of life, mood

VEG decrease in Beck depression score after 24 weeks ( p < 0.001)

Neurotransmitter synthesis and receptor dynamics, increase in voluntary control over food intake

Small sample

Large sample

Beezhold et al., 2014

Retrospective cohort study

To determine association between mood and lifestyle factors in VG, VEG, OMN

Plant-based dietary pattern

Negative measure: symptoms of depression and anxiety stress (DASS-21)

Age inversely associated with DASS score ( p < 0.05), vegan inversely associated with DASS score ( p < 0.001);

significant lower anxiety in male cohorts compared to OMN (VEG: p = 0.022, CI95 = -0.401– -5.140; VG: p = 0.002, CI95 = -1.03– -4.56); significant lower stress scores in VG females compared to OMN ( p = 0.007; CI95 = -0.56– -3.51)

Animal product, fruit/ vegetable (antioxidant content), processed food intakes; ability to cope with stress/ anxiety helps to maintain plant-based dietary pattern; chronic inflammation

Self-reporting; selection bias (recruited participants from websites for health-conscious individuals); social desirability

Further studies on the direct and indirect effects of lifestyle on mood; efficacy of dietary treatment for mood disorders

Matta et al., 2018

Cross-sectional study

To determine the relationship between depressive symptoms and vegetarianism

Dietary pattern, exclusion of food groups

Odds ratio

Depressive symptoms were 1.43 times more likely in pesco-vegetarians (CI95 = 1.19–1.72) and 1.36 times in lacto-ovo-vegetarians (CI95 = 1.09–1.70)

Nutritional deficiency (iron, calcium, zinc, vitamin B12, vitamin D, n-3 fatty acids)

Self-reporting; inability to state causality; lack of information on nutritional status (caloric intake); confounders

Further studies should include a larger sample vegan individuals; a longitudinal study to uncover temporal link (depressive

symptoms and dietary patterns); remove confounders

Burket et al., 2014

Cross-sectional study

To determine differences between dietary habits and health-related variables

Dietary habit

Self-perceived health, chronic conditions (incl. mental illness)

Significantly higher prevalence of mental illnesses (anxiety disorder, depression) in VEG compared to OMN ( p = 0.036)

Self-reporting, inability to state causality; lack of information on nutritional status (macro proportions)

Further studies should focus on nutrition status

Velten et al., 2018

Cross-sectional; longitudinal study

To determine the association between lifestyle factors on positive mental health.

Lifestyle factors (VEG, smoking, alcohol, PA)

Negative: symptoms of depression and anxiety stress (DASS-21)

Positive measure: P-scale

Both cohorts had lower positive mental health and more mental health problems ( p < .001)

Variation of lifestyle factors

Variation of lifestyle factors; inability to state causality; not generalizable

Future studies should introduce lifestyle changes individually

Schreiner et al., 2019

Cross-sectional; prospective cohort study

To determine the association between VEG and gluten-free diets on psychological wellbeing in IBD patients

IBD

VEG

Post-traumatic stress diagnostic scale (PDS); SF-36

VEG had a higher PDS score of 7.4 compared to control ( p = 0.042) and a lower SF-36 score of 45.6 compared to control ( p = 0.008)

Psychological mechanisms; transitioning to a vegetarian diet related to onset of disorders (mental disorder directly impacts the adoption of plant-based diet or independently)

Self-reporting, inability to state causality; some biomarkers were not measured; variability of duration participants had been following the diet

Take lipid measurements, instead of relying on previous records from participant’s physicians

Hossein-zadeh et al., 2016

Cross-sectional study

To investigate the relationship between dietary pattern and psychological disorder prevalence

Diet

Odds ratio

♀ VEG are 35% less likely to have depression (CI95 = 0.46–0.91); ♀ traditional diet are 42% more likely to have depression (CI95 = 1.01–1.99) and 56% more likely to have anxiety (CI95 = 1.00–2.42);♂ Western diet are 73% more likely to have depression (CI95 = 1.07–2.81)

Inflammation; oxidative stress

Self-reporting; inability to state causality; selection bias; not generalizable

Future studies should investigate specific food or nutrition components

Prevalence of mental health disorders

Michalak et al., 2012

Retrospective cohort study

To determine association

between vegetarian diet and mental disorders in community-based sample

Dietary pattern

Prevalence of mental disorders (depressive, anxiety, somatoform, and eating disorders)

VEG: 1.77 times more likely to suffer from lifetime anxiety disorders than non-veg counterparts (CI95 = 1.12–2.79); 1.75 times more likely to suffer from unipolar depressive disorders after 1 year (CI95 = 1.03–2.99)

Psychological mechanisms; transitioning to a vegetarian diet related to onset of disorders (mental disorder directly impacts the adoption of plant-based diet or independently)

Self-reporting; one-item measure for vegetarian diet (no room for diversity of plant-based diets)

Further studies that make clear definitions of all vegetarian dietary patterns and nutrition status; investigate cross-cultural differences

Meesters et al., 2016

Case-control study

To determine the association between SAD and vegetarianism

Vegetarian

Odds ratio

SAD patients are 3.9 times more likely to be VEG ( p = 0.000, CI95 = 1.84–8.45); VEG are 3.9 times more likely to have SAD ( p = 0.000, CI95 = 1.81–8.36); Significant results noted in total population and women cohort

Serotonin pathway affected by animal protein (tryptophan)

Not a representative SAD sample (generalizability); self-reporting; inconsistent SAD definitions

Prospective longitudinal study to investigate risk of developing SAD

Sánchez-Villegas et al., 2015

Prospective cohort study

To compare three dietary patterns with their effect on depression

Dietary pattern

Hazard ratio

Med. 16% lower risk (CI95 = 0.69–1.02); Pro-veg 26% lower risk (CI95 = 0.61–0.89);

AHEI-2010 40% lower risk (CI95 = 0.49–0.72)

Self-reported; not representative sample (generalizability); confounding factors

Future studies should investigate

Motivators of a vegetarian dietary pattern

Hessler-Kaufmann et al., 2020

Retrospective cross-sectional

To determine the relationship between motivation of diet and depressive symptoms

Motivation for diet

Düsseldorf Orthorexia Scale (DOS) score

Depressive symptoms

Patient health questionnaire (PHQ) depression scores

Significant relationship effect between group and DOS scores when predicting PHQ depression scores ( p = 0.01); semi-veg with high DOS score associated with higher PHQ depression scores (p = 0.002) than OMN or VEG

Dissonance between ideals and behaviour

Not representative sample (generalizability); self-reporting

Further studies on Reason and motivation for dietary patterns

Lavalee et al., 2019

Cross-sectional, longitudinal study

To determine association between vegetarianism and mental health cross-culturally over time

Vegetarian

Negative: symptoms of depression and anxiety stress (DASS-21)

Positive measure: P-scale

No relationship between VEG and control in US, German, Russian cohorts

Higher prevalence of depression among Chinese VEG students (R2 = 0.087; p < 0.001)

Motivations for adopting vegetarian diet (economical instead of healthy choice)

Self-reporting; lack of information on nutritional status (macro proportions); did not use comprehensive mental health measures; SES measures not consistent

Further studies on the impact of specific dietary intakes on mental health

Forestell et al., 2018

Cross-sectional study

To determine relationship between vegetarianism and personality in men and women

Dietary pattern

VEG significantly more depressed than omnivores ( p < 0.001), no significance between VEG cohorts ( p = 0.155)

Not a representative sample (generalizability); small effect size; inability to state causality

Investigate reason and motivation for dietary patterns

Vegan (VG); lacto-ovo vegetarian (VEG); omnivore (OMN); depression and anxiety stress score (DASS); profile of mood states (POMS); seasonal affective disorder (SAD); polyunsaturated fatty acids (PUFA); arachidonic acid (AA); inflammatory bowel disease (IBD); physical activity (PA); fatty acid (FA).

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What does literature reports about anti-inflammatory, anti-oxidant dietary approaches to mitigate fibromyalgia symptoms? Literature Review FDNT 680 – Research Seminar Dr. Anjejo Andrews University April 24, 2020.

Literature Review

What does literature reports about anti-inflammatory, anti-oxidant dietary approaches to mitigate fibromyalgia symptoms?

Background: Fibromyalgia (FM) is defined as a chronic neurological disease that amplifies pain perception throughout the whole body muscles. It is associated with high levels of oxidative stress and with a weak antioxidant capacity causing pro-inflammatory pain, being middle age women are the most affected. Dietary interventions might help in improving mechanisms of redox.

Purpose: To review what literature says about the impact of anti-inflammatory/anti-oxidant dietary approaches on FM symptoms.

Methods: The databases used to find the articles were Ebsco host, PubMed, Deeo Dyve, and Google Scholar from 1993 until 2019, with a total of 10 experimental studies in humans included. The key words used to find them were “fibromyalgia”, “diet”, “nutrition”, “vegan”, “vegetarian”, “plant-based”, “women”, “meat consumption”, “chronic pain”, “elimination diet”, “anti-inflammatory, anti-oxidant dietary approach”.

The target population was adult women diagnosed with FM. Articles from non-peer review journals, systematic or meta-analysis reviews, and with participants with co-morbidities requiring specific nutritional interventions, pregnant women, and breastfeeding women were excluded.

Conclusion: Overall, vegetarian/vegan diets, IGUBAC diets, and Supplementation delivered a significant decrease in FM symptoms, especially somatic pain, while the intervention period last.

Dietary interventions focusing on anti-inflammatory and anti-oxidant rich food such as happens with well-balance vegetarian/vegan diets and other diets that eliminate pro-inflammatory/oxidant substances, may have the potential to ease FM symptoms and to deliver a better quality of life to women suffering from FM.

Introduction

Fibromyalgia (FM) is defined as a chronic neurological disease that amplifies pain perception throughout all body muscles. It mainly involves the central nervous system. People with this condition experience extraordinary pain sensitivity. Other symptoms include chronic fatigue, headaches, weakness, mood changes, anxiety, and problems with memory and concentration. Inability to feel well rested even when sleeping through the night and/or inability to have an uninterrupted sleep; inflexibility (especially in the morning) and feeling of light stings in hands and feet are also present (Mayo Clinic, 2017 & The American College of Rheumatology, 2019). Irritable bowel syndrome (IBS) and Non-Celiac Gluten Sensitivity (NCGS) are conditions that commonly co-exist with FM (Mayo Clinic, 2017 & ACR, 2019.). The etiology of this condition has been difficult to identify and is poorly known. However, suggested possible causes include premature aging of the nervous system (Rusell & Larson, 2009), a defect of the brain’s chemicals (neurotransmitters) unable to inhibit pain perception (Buskila, D., 2009 & Treister, R. et. al., 2009), hormonal imbalances (the National Fibromyalgia Association (NFA), n.d.), and the inability of the body to detoxify itself appropriately (Lamb, et.al., 2011). According to the Centers for Disease and Control and Prevention (CDC, 2017) and to the NFA (n.d.), FM affects between 4 to 5 million of US adults. Risk factors associated with FM involve a traumatic event (physical and/or mental), family history (having a close relative with FM may post a risk 8 times greater than people who don’t have it), virus infections, obesity, lupus, and rheumatoid arthritis (CDC, 2017, ACR, n.d., Arnold et. al. 2004, Firestone, et.al, 2012). FM can affect everyone at any stage of life, but the most prevalence occurs in middle age women (between ages 30 to 40) accounting for about 75% to 90% of all cases (NFA, n.d. & Weir et. al. 2006). FM symptoms are also more prominent or intensified in women (NFA, n.d.).

FM economical burden varies from $100 to $1000 per month, per patient, after insurance covering (NFA, n.d.). The management of FM is multifactorial because no single approach is sufficient. The conventional approach includes painkillers approved by FDA for FM, such as duloxetine (Cymbalta), milnacipran (Savella), and pregabalin (Lyrica). The non-medicated treatment that has been suggested include aerobic exercise, yoga, Tai Chi Chinese martial arts, stress management with Cognitive behavioral therapy, acupuncture, chiropractic, physical therapy, and massages (Firestone, 2012 & ACR, 2019). The nutritional approach has been lightly studied. Overall, studies have shown that some foods may aggravate FM symptoms, that anti-inflammatory/anti-oxidant rich foods, and nutrient supplementation may have a positive impact on symptoms (Rossi, A. et.al., 2015). Studies have linked FM with high levels of oxidative stress and with a weak antioxidant capacity (Rossi, A. et.al., 2015) Vegetarian/vegan diets have proved to offer great benefits on human health due to its higher intake of anti-inflammatory and anti-oxidant food items (Kim, M.K., et.al. 2012, Le, L.T. & Sabaté, 2014). For that reason, this literature review intends to discuss what studies show about the impact of anti-inflammatory/anti-oxidant dietary approaches, including supplementation, on fibromyalgia symptoms in women. The hypothesis is that anti-inflammatory/anti-oxidant diets such as well-balanced vegetarian and/or vegan diet along with supplementation of nutrients of concerns in FM patients have the potential to improve quality of life and to reduce FM symptoms.

Methodology

Search Strategy

The search was conducted from October 2019 to April of 2020. Selected studies were chosen from the years 1993 to 2019. All studies were retrieved online from the databases Ebsco host, PubMed, Deep Dyve, and Google Scholar using the following key words; “fibromyalgia”, “diet”, “nutrition”, “vegan”, “vegetarian”, “plant-based”, “women”, “meat consumption”, “chronic pain”, “elimination diet”, “anti-inflammatory, anti-oxidant dietary approach”.

Study Selection

The target population was adult women officially diagnosed with Fibromyalgia using The American College of Rheumatology criteria. All the articles were restricted to English language (except for one in Spanish), to be peer-reviewed from scientific journals and to the experimental, quasi-experimental, crossover, clinical trial study design in humans. Systematic or meta-analysis reviews, populations with co-morbidities requiring specific nutritional interventions, pregnant women, and breastfeeding women were excluded.

Data extraction

Titles and abstracts were first identified and revised to determine if they could be included in this review. In the studies, the main exposure searched was diet (especially vegetarian and/or vegan diet). The main outcome searched was fibromyalgia symptoms. The type of diets, the type of intervention, duration of the intervention, age and gender of participants, and country of the study was also extracted directly from the articles.

Flow Chart

Results

Table 1. Characteristics of the included studies.

Source

Duration (wks/months)

Country

*Total participants

Age (years)

Diet

Nutritional Status

Paula Marum, et.al. (2017)

8 weeks

Portugal

31

18 – 70

(Mean: 51)

FODMAP

-

Martínez-Rodríguez, et. al. (2017)

4 weeks

Spain

21

34 ± 3

Lacto-vegetarian

Mean BMI: 23 (normal)

Kaartinen., et. al. (2000)

3 months

Finland

28

34 – 62

(Mean: 51)

Vegan-Raw

Mean BMI: 28

(overweight)

Lamb, et.al (2011)

8 weeks

USA

8

48 – 74

(Mean: 55.6)

Hypoallergenic, modified diet + supplementation with phytonutrients-rich medical food 2x/d.

Mean BMI: 32.9

(overweight)

Range: 20.4 to 44.8

Massey, P. (2007)

8 weeks

USA

7

38 - 65

Modified Myer’s formula - intravenous

-

Donalson, M. et.al., (2001)

7 months

USA

20

45 - 54

Hallelujah Diet

(mostly raw vegetarian)

-

Mauro-Martín, I., et. al (2018)

2 months

Spain

31

30 - 70

(Mean: 55.87)

CibusOlivo supplement

IGUBAC Diet

Mean: 26

(overweight)

Towery, P., et. al. (2018)

8 weeks

USA

22

19 – 71

(Mean: 48)

Lacto-ovo-vegetarian diet.

Mean: 36

(overweight)

Hostmark, A.T., .et.al (1993)

3 weeks

Norway

10

Mean: 49.9

Vegetarian diet (+fasting 8-10 days)

-

Mauro-Martín, I., et. al (2019)

1 month

Spain

13

30 - 60

Turmeric supplement

IGUBAC Diet

Mean: 27

(overweight)

*Number of participants who completed all trials.

A total of ten full text articles were retrieved from online databases and included in this review, all of them had nutritional interventions. Six studies didn’t have a control group. The duration of intervention of the studies was between 3 weeks to 7 months. There are a total of about 273 subjects who participated among all studies from USA (4x), Norway, Spain (3x), Portugal, and Finland. The subjects’ age in the studies fluctuated from 18 to 74 years of age. Most participants were women. The participation of males was limited to two studies with a total 4 males. One study didn’t specify the gender of the subjects. Dietary interventions included in this review were anti-inflammatory in nature. Six studies used vegetarian/vegan diets, three studies focused on IGUBAC diet or FODMAP diet, and one study focused on keeping subjects’ regular diet but supplementing with an antioxidant rich formula via intravenous.

Vegetarian diets

All vegetarian/vegan diet interventions promoted mostly a significant decrease in musculoskeletal pain. As a consequence, participants also improved their quality of life, with some of them reporting significant decrease in fatigue, stiffness and better sleep as well. However, Martínez-Rodríguez, et. al. (2017) reached statistical significance only when vegetarian diet was followed along with core exercise. The control group following a vegetarian diet with no exercise didn’t experience changes in symptoms.

IGUBAC/FODMAP Diet

The use of FODMAP diet by itself reached significant decrease in musculoskeletal pain and gastrointestinal symptoms. IGUBAC Diet intervention mostly showed a non-significant tendency to improve FM symptoms such as pain and fatigue. It reached significant decrease in pain intensity and in their perception of Pain Catastrophizing.

Supplementation

Modified Myer’s-Formula, intravenous nutrient therapy, also promoted a significant decrease in pain and fatigue. Energy level was increased. No dietary intervention (usual diet was not described).

Supplementation with olive oil showed some improvement in Pain Catastrophizing questionnaire and Fatigue Severity Scale, both not significant. Turmeric supplement showed a moderate change for Fatigue Severity Scale. It also showed, statistical significance for pain intensity.

In all studies, FM symptoms do not disappear in its entirely but the mitigation of pain and other symptoms are significant.

Table 2. Summary of Findings per Study

Author

s (year)

Study design

Main Objective

Exposure (or independent variable)

Outcomes Measured

Main Findings (Include numeric data)

Rationale (Mechanisms explaining the findings)

Study Limitations and Gaps

Research Recommendations

Paula Marum, et.al. (2017)

Longi-tudinal study

(Pilot Clinical Trial)

To study the impact of FODMAP diet on FM symptoms and nutritional status.

(8 weeks)

FODMAP Diet

FM symptoms

-Significant  (p < 0.01) in all FM symptoms, including GI symptoms (abdominal pain, distention) after 4 weeks.

-Somatic pain  (p < 0.01).

-Muscle Tension 

(p < 0.01).

The elimination of poorly absorbed, short chain CHO, fructose, lactose, polyols, fructo-oligosaccharides, galacto-oligosaccharides alleviate GI disorders especially gases and distention.

-Small sample size.

-Short intervention period.

-No control group.

Authors suggested studies to analyze the impact of FODMAP diet over the neuro-enteric axis of FM patients and the cost/benefits of implementing FODMAP diet as part of the FM treatment.

Martínez-Rodríguez, et. al. (2017)

RCT

To analyze the impact of physiotherapy treatment along with a lacto-vegetarian diet over FM pain.

(4 weeks)

Group A: Lacto-vegetarian diet + core exercise.

Group B: Lacto-vegetarian diet.

Group C: Control

(No supplementat-ion)

FM symptoms

Group A: Significant  in low back pain.

Group B: No effect.

Strengthe-ning of the abdominal muscles & lumbar region promoted the  of the fat mass & the  of the lean mass.

Lacto-vegetarian diet by itself didn’t improve low back pain, but prevent weigh gain. 

-Small sample size.

-Short intervention period.

Authors suggested studies to analyzed the impact of physiotherapy + vegetarian diets on blood biochemical parameters.

Kaarti-nen, K. et.al. (2000)

Experimental (non-randomi-zed control)

To study the effect of a vegan diet on FM symptoms.

(3 months)

Vegan - Raw diet.

(Supplement of B12)

Control group: omnivore diet.

FM symptoms

 in the use of pain-killers (not significant, p = 0.053).

Significant  in pain (p = 0.005). It disappeared gradually when shifting back to omnivore diet.

Significant improvement in sleep’s quality (p=0.0001), morning stiffness (p = 0.0001), general health (p = 0.02), & subjective feelings (p = 0.038).

♯ of tender points non-significant  (p = 0.07). Showed only tendency.

Weight loss potentially  levels of pro-inflamma-tory cytokines & CRP.

The  antioxidant intake lead to the decrease in the production of free superoxide radicals, which in turn will interrupt the synthesis of TNF-Alfa & IL-Beta, both involved in inflamma-tory pain.

 in antioxidant =  in reactive oxygen species (ROS) = improved in mitochondrial functioning = ATP for muscle =  pain.

(Rossi, A. et.al., 2015).

-Small sample size.

-Short intervention period.

-Didn’t offer mechanism-explaining results.

-Not blindly randomization.

Authors suggested further crossover design studies about veganism over FM symptoms.

Lamb, et.al (2011)

Crossover Trial.

To assess the effectiveness of a novel lifestyle program on FM clinical symptoms & detoxification.

(8 weeks)

Program A: Standard American Diet based on USDA rec.

Program B: Hypoallerge-nic, modified elimination diet + supplementa-tion with phytonutrients-rich medical food 2x/d.

FM clinical symptoms.

Program B: lower mean on all *questionnaires scores.

Statistical significance only for FIQ pain and stiffness scores (p < 0.05).

Had better tolerance to 5 tender points.

Higher mercury excretion (not significant).

Trend of  excretion of arsenic (p = 0.056).

Expression of Metallothionein mRNA increased by 54%.

Program B added a phytoche-mical-rich medical food, which may have provided nutrients that FM patient’s lack. Also, it has ingredients that support hepatic detoxifica-tion against metals.

Increased in Metallothio-nein mRNA expression promoting the binding function of this protein with toxic elements such as mercury, cadmium, lead, arsenic, which in turn  ROS.

-Small sample size.

-Short intervention period.

-Interindi-vidual differences.

-Lower statistical power to detect treatment efficacy.

-No washout period between Program A & B.

-Program A may have had therapeutic benefits.

-No control group.

Authors suggested further long clinical trials to evaluate intermediate & long-term effects with larger sample size.

Massey, P. (2007)

Clinical Trial

To evaluate the effectiveness of a modified Myer’s formula of intravenous nutrient therapy (IVNT) on the symptoms of FM in therapy-resistant patients.

(8 weeks)

IVNT Modified Myers’ Formula

(Mg, Ca++, Vit.C, Complex B-Vit.).

FM symptoms

Pain & fatigue levels decreased (p = 0.005).

Increased in energy level.

Increased Vit. B complex and Vit. C are involved in the production of neurotransmitters, which can change perception of pain.

Anti-inflamma-tory effect of magnesium.

-Small sample size.

-Short intervention period.

-No control group.

Author suggested further investiga-tion of the IVNT MMF on FM symptoms with larger, randomi-zed, placebo-controlled clinical trials.

Donaldson, M.S., et.al. (2001)

Quasi-experimental

To evaluate the effect of a vegetarian diet on FM symptoms.

(7 months)

Halle-lujah Diet

FM symptoms

FIQ: after 2 months the score improved 33%.

At 7 months: improved by 46%.

(p < 0.05).

**QOL and SF-36 questionnaires improved (p < 0.05)

Synergistic effect (physiological and psychological factors).

-Small sample size.

-No control group.

-Authors mentioned that even though all participants had been diagnosed with FM before, at the moment of the study some of them didn’t meet the dx criteria (didn’t have severe pain).

Authors suggested further studies with a larger, controlled trial.

Mauro-Martín, I., et. al (2018)

RCT

To evaluate the effect of an olive tree-based dietary supplement and FODMAP diet on FM symptoms.

(2 months)

Group 1: Control

Group 2: Olive tree-based food supplement.

Group 3: IGUBAC Diet (Inflammatory Gut-Brain Axis Control Diet = low FODMAP diet, gluten-free, low histamine & other amines, preservative free, natural food).

FM symptoms

G3 had the greatest positive Δ for Chronic Pain Grade Scale (p = 0.046)

G3: greatest  in Pain Catastrophizing questionnaire. G2 followed closely.

(Not significant for both)

Not significant  for G2 (more pronounce ) & G3 in Fatigue Severity Scale (p > 0.05).

Phenolic compounds in olive oil have a strong antioxidant activity linked in the protection of lipids, proteins, & DNA from ROS. In turn, oxidative stress . Symptoms will also .

FODMAP  GI discomfort.

-Small sample size.

-Short intervention period.

-Treatment composed by so many different components

Authors suggested further research to clarify the role of the different treatment compo-nents.

Towery, P., et.al. (2018)

Longitudinal/Quasi-experi-mental.

To analyze the impact of a plant-based diet on chronic musculoskeletal pain & functionality.

(8 weeks)

Lacto-ovo-vegetarian diet.

Chronic pain

Significant  in pain by 3.14 points (p = 0.0001).

Significant improve of 25 points in quality of life (p = 0.0001).

 exposure to pro-inflamma-tory precursors.

Free-radicals are neutralized.

Improve-ment in lipid profile = strengthen vascularization.

Relationship between plant-based diets and mental perceptions of well-being.

-Small sample size.

-Short intervention period.

-No control group.

-Subjects & Researchers were not blinded.

-Self-reported food intake.

-Sample of conve-nience (generali-zation may not be warranted).

Authors suggested further research of the same topic with a control group.

Hostmark, A.T., et.al. (1993)

Quasi-Experimental

To study the effect of a vegetarian diet on plasma fibrinogen. Lipid profile, and serum peroxide concentration in subjects with FM.

(3 weeks)

Vegetarian diet & fasting.

FM symptoms as secondary outcomes.

Positive effect on pain status (statistical significance was not revealed).

Significant  in lipid peroxide formation (p = 0.01)

 intake in antioxidants =  oxidative stress (ROS) =  in serum peroxides =  the oxidation of lipids (lipid oxidation promote inflammatory pain due to direct peripheral sensitization & the release of cytokines) =  in pain.

 lipid peroxidation also  damage to phospho-lipids in cell membrane in the brain =  alteration of neurotransmitters systems =  depression symptoms.

Cordero, M.D., et.al. (2011).

-Small sample size.

-Short intervention period.

-No control group.

-Physical activity may have had positive effect.

-The type of vegetarian diet wasn’t specified.

No suggest-ions from authors.

Mauro-Martín, I., et. al (2019)

RCT

To study the effects of a turmeric supplement & IGUBAC Diet on FM symptoms.

(1 month)

Group 1: Turmeric Supplement + IGUBAC Diet

Group 2:

IGUBAC Diet (Control group)

IGUBAC Diet (Inflammatory Gut-Brain Axis Control Diet = low FODMAP diet, gluten-free, low histamine & other amines, preservative free, natural food).

FM symptoms

Patients with Grade III of Chronic Pain (high disability-moderately limiting) improved the Chronic Pain Grade Scale in Group 2.

Moderate Δ in both groups for Fatigue Severity Scale. More pronounce  for Group 1 (Not significant).

Statistical significance for pain intensity (p < 0.05)

Significant  in Pain Catastrophizing for Group 2 (p = 0.011).

Slight improvement in sleep efficiency for Group 2 (not significant).

Turmeric is a great source of potent antioxidants such as bisacurone, it has anti-oxidant & anti-inflamma-tory activities.

IGUBAC Diet  GI symptoms and pain.

.-Small sample size.

-Short intervention period.

Authors suggested further investiga-tions to clarify current results.

*FIQ = Fibromyalgia Impact Questionnaire, MSQ = Medical Symptom Questionnaire, FibroQuest = FibroQuest Symptoms Survey.

**QOL = Quality of Life Survey, SF – 36 = 36-Item Short Form Health Survey. 

Discussion

The results of this literature review shows evidence that anti-inflammatory and anti-oxidant dietary intervention and/or supplementation have the potential to ease FM excruciating symptoms, especially somatic pain. Vegetarian and vegan diets achieved significance on reducing musculoskeletal pain, the most prominent symptom in subjects with FM. Significant improvements in symptoms such as fatigue, inflexibility, and poor sleep were also reported following these diets. Half of these diets were very restrictive, approving only the consumption of raw or mostly raw foods and not allowing any added sugar, refined products, food additives, and caffeinated beverages (Kaartinen, et. al., 2000; Lamb, et.al., 2011; & Donaldson, M.S., et.al., 2001). In addition, Hostmark, A.T., et.al. (1993), did include fasting for 8 – 10 days in his 3 weeks intervention with vegetarian diet. Its main focus was lipids and other biomarkers, but found out that FM pain was decreased in subjects. One of the interventions achieved significance only when core exercise was done along with vegetarian diet (Martínez-Rodríguez, et. al., 2017). But overall, even though vegetarian diets vary per study, they seems to mitigate FM symptoms, especially when are followed focusing of fresh foods, supplementing with phytonutrients, and limiting food additives.

Significant decrease in musculoskeletal pain and gastrointestinal symptoms was also seen following the FODMAP diet by itself. IGUBAC Diet (Inflammatory Gut-Brain Axis Control Diet = low FODMAP diet, gluten-free, low histamine & other amines, preservative free, natural food) intervention, showed a tendency to mitigate symptoms, but didn’t reach statistical significance. Even though they are not a plant-based diet, it limits or discourages the use of dairy and processed meat, high fructose corn syrup and artificial sweeteners, focusing mostly on fresh foods and meats (Mauro-Martín, I., et. al., 2018).

Isolated supplementation with Turmeric and Olive oil had low to moderate effects on FM symptoms when compare with diet intervention. Turmeric along with IGUBAC diet reached statistical significance for pain intensity. The strongest effect seeing in dietary interventions could be explained due to the synergistic work of the different nutrients in a diet when compare with isolated substances (Jacobs, D. R., et.al., 2009).

In the review by da Silva, A. F., et. al. (2017) oxidative stress, the use of antioxidants, body weight, and micronutrient deficiency was addressed. They stated that oxidative stress in patients with FM produces triple the amount of ROS than non-FM patients, exacerbating chronic fatigue. They concluded that a healthy diet among other interventions might represent a decrease in fatigue and/or pain symptoms, improving quality of life. However, they couldn’t establish a solid diet – FM association due to the lack of rigorous studies. According to the findings in this review, it can be agreed that the lack of well-controlled studies on diet (especially on plant based diets) makes the development of nutritional recommendations difficult. Rossi, A., et. al. (2015) discusses in their review, the oxidant – antioxidant imbalance found in people with FM and the improvements seeing in FM symptoms on patients adopting an antioxidant rich diet. It also describes how the elimination of excitotoxin substances such as Monosodium Glutamate (MSG) and aspartame and the micronutrient supplementation (especially magnesium) have the potential to ease FM symptoms. Results in this review agree with those statements. Firestone, K., et. al. (2012) also discusses briefly the possible benefits of vegan diets for been rich in antioxidants and for not including food additives such as MSG and aspartame. In addition, it is mentions that FM patients tends to be low in some micronutrients that have an important role in redox mechanisms and that a whole nutritious diet can diminish FM symptoms. This review agrees on diets rich in antioxidants, with supplementation, and elimination of food additives having a positive effect on FM symptoms. It is important to highlight that Kim, M. K., et. al. (2012) found that a group of people who had followed a vegetarian diet for long time in Korea (mean duration was close to 25 years) had major intake of iron, vit.C, vit. A and other antioxidants than omnivores, and that vegetarians showed a significant lower levels of oxidative stress than omnivores. Beezhold, B., et. al. (2015) discusses in their study that vegans reported less anxiety and stress levels than omnivores possibly due to the higher intake of anti-inflammatory/anti-oxidants substances from nutritious food items such as fruits and veggies. On the contrary, Azad K.A., et. al. (2000) in its RCT of 37 subjects with FM concluded that a vegetarian diet was not the best approach because even when pain had a significant decrease, it had a lower impact when compare to the amitriptyline group (analgesic and sedative drug). However, the dietary intervention had a positive effect on pain.

Several mechanisms have been proposed to explain the beneficial effects of dietary and supplementation approaches focusing on delivering high amounts of anti-oxidant/anti-inflammatory substances on FM symptoms. First, vegetarian/vegan diets tend to promote weight loss. When weight loss is achieve, levels of pro-inflammatory cytokines & CRP has also the potential to decrease (Kaartinen, K. et.al., 2000). Second, the increase in antioxidant intake lead to the decrease in the production of free superoxide radicals, which in turn will interrupt the synthesis of TNF-Alfa & IL-Beta, cytokines involved in inflammatory pain (Kaartinen, K. et.al., 2000). Third, increase intake of antioxidants can decrease the production of reactive oxygen species (ROS), which in turn might improve mitochondrial functioning resulting in more ATP for muscle, decreasing musculoskeletal pain (Rossi, A. et.al., 2015). Also, when a phytochemical-rich medical food that provides nutrients that FM patient’s tend to lack and its ingredients support hepatic detoxification against metals, the expression of Metallothionein mRNA promote the binding function of this protein with toxic elements such as mercury, cadmium, lead, and arsenic, leading to their excretion and as a consequence, decrease in ROS production (Lamb, et.al., 2011). In addition, decrease in lipid peroxidation also decrease damage to phospholipids in cell membrane in the brain, having less alteration of the neurotransmitters systems, ameliorating depression symptoms (Cordero, M.D., et.al., 2011). It has been stated that FM patients tends to be low is some nutrients related to neurological health. The supplementation of intravenous Modified Myers’ Formula promoted an increased in Vit. B complex and Vit. C, both involved in the production of neurotransmitters responsible for changing pain perception (Massey, et. al., 2007). Finally, these diets limit processed foods. Processed foods are an excellent source of excitatory neurotransmitters such as MSG & aspartame. Its elimination from diet have shown the capacity to avoid neurotoxicity and to mitigate FM symptoms (Holton, K.F., et.al., 2012).

Low FODMAP diets have been proposed to treat FM GI symptoms due to the fact that FM and irritable bowel syndrome (IBS) are correlated (Mauro-Martín, I., et. Al., 2018). Paula Marum, et.al. (2017) states that 70% of patients with FM also report IBS symptoms such as abdominal pain and distension. It has been proposed that the release of gases from bacterial fermentation of FODMAP lead to ascending messages that are interpreted as pain and discomfort. However, a FODMAP diet is not for a long-term used because is too restrictive and it is mostly used in two or three phases to identify those foods that cause discomfort (Hill, P., et. al., 2017).

Even when studies have suggested the benefits of dietary interventions to ease FM symptoms, this approach still underestimated and under investigated with no official inclusion in FM treatment by physicians or major advocates. It is also important to take in account that vegetarian/vegan diets may not be easy to follow for many, but if more researches keep promoting its benefits people may be more open to accept them. Griffiths, K., et.al. (2016) reports another beneficial effect that health care providers and FM patients can take in account when thinking of this dietary approaches to mitigate FM symptoms. That is, the protective mechanism over other chronic diseases such as cardiovascular disease, Type 2 diabetes, and cancer, which are pro-inflammatory/oxidant by nature. The chances of getting a better quality of life might increase if dietary approaches that ensure the intake of food items that neutralize free radicals are encourage as part of the multidisciplinary approach to treat FM.

Strengths

This review may be the only one focusing mostly on vegetarian/vegan diets intervention to treat FM symptoms. Even though it should be taken carefully and individualized, results might be generalized to all women with FM that otherwise are not suffering from other serious chronic diseases or allergies.

Limitations

All studies in this review had a very small sample size and a very short intervention period. Many of the studies lack of a control group and more recent studies are needed. There are a few other supplementation that have been used with positive effects that are not included in this review.

Conclusion

Dietary interventions focusing on anti-inflammatory and anti-oxidant rich food such as happens with well-balance vegetarian/vegan diets and other diets that eliminate pro-inflammatory/oxidant substances, may have the potential to ease FM symptoms and to deliver a better quality of life to women suffering from FM. Its effects can even be more pronounce when use along with other medical and non-medical approaches according to individual needs. Long-term RCT studies about the long-term effects of these types of dietary interventions on FM symptoms are deeply needed and encourage to been able to develop an official nutritional intervention.

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Articles included in this review: 10

2

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A Review On The Effect Of Intermittent Fasting On Weight Loss

Shelly Schick Andrews University

FDNT-680-999 Research Seminar July 1, 2020

Introduction: Epidemiology ● Obesity:

○ BMI =/> 30 & caused by genetic & environmental factors and behaviors like a poor diet & sedentary lifestyle

○ Leads to: HTN, Dyslipidemia, CVD, T2DM, Stroke, Sleep Apnea, Depression, Cancer, etc. (CDC, 2020)

○ Costs billions of $$ in medical expenses (CDC, 2020)

○ 2017-2018: 42.4% of adults in the US were obese (CDC, 2020)

Introduction ● Intermittent Fasting (IF):

○ Ramadan, Muslims fast between sunrise and sunset for religious purposes, rather than weight loss

○ Various versions: ■ Fasting from 6pm-10am and

feasting from 10am-6pm ■ Fast for 2 days/week and eat

regularly for the other 5 days ■ “Fast” = 25% of energy needs

or low calories (i.e. 500 calories)

Introduction: Aim of Review

To conduct a literature review looking at the relationship/effectiveness of IF on body weight (with a specific focus on weight loss) to see if IF can help

those who are obese lose weight

Methodology: Literature Search ● EBSCO, Google Scholar, and PubMed

○ Keywords: “intermittent fasting” “weight” “weight loss” “humans or people” and “BMI”

○ Peer-reviewed & within the past 15 years (from 2005-2020).

○ Inclusion criteria: (1) An experimental study design, (2) A study population of adults, (3) An exposure of intermittent fasting, and (4) An outcome of body weight.

○ Exclusion criteria: (1) Any study that was conducted on animals or (2) any study that was conducted more than 15 years ago (before 2005)

Methodology: Data Extraction ● 10 experimental studies (9 RCTs & 1 quasi-experimental) ● Many of the studies looked at other outcomes, like

changes in waist circumference, insulin sensitivity, blood pressure, & lipid levels (specifically, HDL cholesterol, LDL cholesterol, & triglycerides) ○ Only information pertaining to body weight was

included in the analysis ○ Information taken from the studies:

■ Main objective ■ Exposure/intervention ■ Main results/findings and conclusions ■ Study limitations

Results ● 10 experimental studies

○ 9 randomized control trials ○ 1 quasi-experimental

● Intervention time periods: 6 weeks to 6 months

● Sample size of the study population: 15 to 162 participants

● 9/10 studies included study population of participants who were obese ○ 1 study didn’t have any

comorbidities in its study population (Heilbronn et al., 2005)

Results Author (year)

Main Objective Exposure/Outcome Measured

Type of Analysis (α & p-value)

Bhutani (2013)

To investigate whether alternate day fasting (ADF) with exercise has a greater effect on body composition compared to ADF or exercise alone

ADF plus exercise vs. exercise alone vs. ADF alone / Body weight

One‐way ANOVA at baseline; repeated‐measures ANOVA for within‐group differences; Intention‐to‐treat analysis (α: 0.05; p: <0.05)

Bowen (2018)

To compare an energy restriction with ADF to a high-protein, meal replacement program with daily energy restriction (DER) on weight loss

High-protein, meal replacement program with DER vs. energy restriction with ADF / Body weight

Mixed effects linear models (α: 0.05; p: <0.05)

Byrne (2017)

To determine whether intermittent energy restriction (IER) had a greater impact on weight loss efficiency in comparison to continuous energy restriction (CER)

IER vs. CER / Weight loss efficiency

Mixed model repeated measures analyses (α: 0.05; p: <0.05)

Catenacci (2016)

To compare the effects of ADF versus a moderate daily caloric restriction (CR) on weight status

Zero-calorie ADF vs. calorie restriction (-400 kcal/day) / Body weight

Linear mixed‐effects model; Independent‐samples t ‐tests (α: 0.05; p: <0.05)

Eshghinia (2013)

To evaluate the effects of a modified ADF on body weight in obese women

Alternate-day fasting diet / Body weight

Paired T-test (α: 0.05; p: <0.05)

Results Author (year) Main Objective Exposure/Outcome Measured Type of Analysis (α & p-value)

Harvie (2011) To compare the effectiveness & practicality of IER vs. CER on weight loss

IER vs. CER / Weight loss Paired t-tests at baseline & LOCF analysis at 6 months (α: 0.05; p: <0.05)

Heilbronn (2005) To examine if ADF is a practical method of dietary restriction for weight loss in non-obese individuals

ADF / Body weight One- & two-factor repeated-measures analysis of variance (α: 0.05; p: <0.05)

Hoddy (2014) To compare the effects of ADF with three meal times on body weight

ADF with three meal times / Body weight

One way ANOVA, Tukey's post hoc test, & a paired t‐test (α: 0.05; p: <0.05)

Keogh (2014) To investigate the effect of IER versus CER on weight loss

IER vs. CER / Body weight Independent samples t-test at baseline; repeated-measures ANOVA (α: 0.05; p: <0.05)

Trepanowski (2017) To compare the effects of ADF vs. a DER on weight loss

ADF vs. DER / Weight loss Independent-samples t test; a linear mixed model (α: 0.05; p: <0.05)

Results Author Main Finding(s) Conclusion(s) Study Limitations

Bhutani (2013)

Body weight was reduced in all of the intervention groups after 12 weeks (P < 0.05). Body weight decreased by 6 ± 4 kg, 3 ± 1 kg, and 1 ± 0 kg in the ADF plus exercise, ADF, and exercise groups, respectively

ADF plus exercise produces greater amount of weight loss compared to ADF or exercise alone

Short intervention time frame (12 weeks); used BIA to measure fat mass & fat free mass instead of dual‐energy X‐ray absorptiometry (DXA); participants were only from the University of Illinois, Chicago campus (cannot generalized results); flawed randomization procedure

Bowen (2018)

There was a statistically significant decrease in body weight over time (p < 0.001); At week 16 of the intervention, weight decreased by 10.7 ± 0.5 kg & −11.2 ± 0.6 kg in the ADF + DER group and the DER group, respectively (no significant difference between groups)

Both a high-protein, meal replacement program with DER & a energy restriction with ADF support weight loss

No biological data at 6 months; no long-term follow up; small number of male participants; no measurement for energy expenditure & physical activity monitoring

Byrne (2017)

The IER group lost more weight compared to the CER group (14.1±5.6 vs 9.1±2.9 kg; P<0.001); Both groups regained weight after the 6-month follow-up (IER: 3.5±5.9 vs. CER: 5.9±4.7 kg; P=0.24)

IER prodcued a higher amount of weight and fat loss compared to CER

Attrition in study population; small weight loss during baseline period; no measurements for body composition or resting energy expenditure during energy balance blocks in the IER group

Catenacci (2016)

At week 8, the ADF group had a greater energy deficient of 376 kcal/day compared to the CR group; however, no significant changes in weight were seen between the two groups (mean ±SE; ADF -8.2 ± 0.9 kg, CR -7.1 ± 1.0 kg). Finally, after week 24 of unsupervised follow-up, no significant differences in weight regain were seen

ADF & CR produced similar amount of weight loss after the 8 weeks

Pilot study; small sample size; randomization was arranged by sex; small male percentage; no measurements on physical activity; results cannot be generalized

Eshghinia (2013) ADF significantly reduced body weight from 84.3 ± 11.44 kg

to 78.3 ± 10.18 kg (P < 0.001) Short-term ADF is an effective intervention for weight loss

No control groups; small sample size; short intervention time frame (<8 weeks)

Results Author (year)

Main Finding(s) Conclusion(s) Study Limitations

Harvie (2011) IER & CER are equally effective (but not significantly different) for weight loss. The average weight change was -6.4 (-7.9 to -4.8) kg for IER and -5.6 (-6.9 to -4.4) kg for CER (P=0.4)

IER & CER are effective ways to lose weight; IER could be used as an alternative to CER for weight loss

Did not assess long term adherence to IER

Heilbronn (2005)

Participants significantly reduced their initial body weight by 2.5 ± 0.5% (P < 0.001)

ADF is a practical method of dietary restriction for weight loss

Small sample size (16), short intervention time frame (22 days)

Hoddy (2014) Body weight (P  < 0.001) reduction included: ADF‐Lunch: 3.5 ± 0.4 kg, ADF‐Dinner 4.1 ± 0.5 kg, ADF‐Small Meal 4.0 ± 0.5 kg, but there were no significant differences between groups

Consuming the fast day meal at D, L, or SM all produce similar weight loss results

No “breakfast” group; adherence to fasting was self-reported; no control group

Keogh (2014) Weight decreased significantly with time (P < 0.001). There was no significant difference in regard to weight loss between CER and IER after 8 weeks (-3.2 ± 2.1 kg for CER and -2.0 ± 1.9 kg for IER; P  = 0.06) or after 12 months (-4.2 ± 5.6 kg for CER and -2.1 ± 3.8 kg for IER; P  = 0.19); Weight loss between weeks 8-52 was -0.7 ± 49 kg for CER and -1± 1.1 kg for IER; P  = 0.6

Intermittent dieting is as effective as a continuous caloric restriction over a 8 week time frame, as well as for weight loss maintenance at 1 year

60% of participants dropped out (limited power to the study); protocol in the study is different than for IF & ADF

Trepanowski (2017)

At 6 months, the average weight loss between the two groups (ADF vs. DER) was not significantly different (–6.8% [–9.1% to –4.5%] vs. –6.8% [–9.1% to –4.6%], respectively). These same findings were seen after 12 months as well (–6.0% [–8.5% to –3.6%] vs. –5.3% [–7.6% to –3.0%], respectively). No significant weight changes were seen in the control group. Overall, the participants in the ADF group consumed more calories than prescribed on fasting days, however they consumed less calories than prescribed on feasting days. Participants in the DER group met their prescribed caloric intake goals.

ADF did not produce a greater weight loss compared to DER

Short maintenance phase (6 weeks); control group did not receive food/counseling; high dropout rate; limited generalizability; study population was metabolically healthy obese individuals

Results Author (year) Demographics of the study population (n= number of participants)

Bhutani (2013) n= 64; Comorbidities in study population: obesity; Average age (years): 44.5 (range: 25-65); % male: 3.6; % female: 96.4

Bowen (2018) n= 162; Comorbidities in study population: obesity; Average age (years): 40 (range: 25-60); % male: 19; % female: 81

Byrne (2017) n= 51; Comorbidities in study population: obesity; Average age (years): 40 (range: 25-54); % male: 100; % female: 0

Catenacci (2016) n= 26; Comorbidities in study population: obesity; Average age (years): 41.1 (range: 18-55); % male: 24; % female: 76

Eshghinia (2013) n= 15; Comorbidities in study population: obesity; Average age (years): 33.5 (range: 20-45); % male: 0; % female: 100

Harvie (2011) n= 107; Comorbidities in study population: obesity; Average age (years): 40 (range: 30-45); % male: 0; % female: 100

Heilbronn (2005) n= 16; Comorbidities in study population: none; Average age (years): 32 (range: 23-53); % male: 50; % female: 50

Hoddy (2014) n= 74; Comorbidities in study population: obesity; Average age (years): 45 (range: 25-65); % male: 15; % female: 85

Keogh (2014) n= 36; Comorbidities in study population: obesity; Average age (years): 60.2; % male: 0; % female: 100

Trepanowski (2017)

n= 100; Comorbidities in study population: obesity; Average age (years): 44 (range:18-65); % male: 14; % female: 86

Results ● All 10 studies found that following an IF

diet protocol lead to a reduction in weight; the weight loss for IF ranged from 4.4 pounds to 31.0 pounds

● More research needs to be conducted before recommending IF as a means to lose weight since long-term studies on IF have yet to be conducted, although the research does not present any harm in metabolic function in the short-term

Discussion: Overall Findings ● 10/10 studies found weight reduction when following a

IF diet protocol (but varied from article to article) ○ Differences may be due to the differences in study

durations and/or the differences in IF diet protocol. ■ Some had 2-3 fasting days/week where

participants consumed 25-30% of their daily energy needs (Bhutani, 2013, Eshghinia, 2013, Heilbronn, 2005, Hoddy, 2014, and Trepanowski, 2017)

■ Another study had participants fast for 1 week (-1,314.5 calories/day) followed by a regular week (Keogh, 2014)

Discussion: Overall Findings ● Most of the studies did not find any significant

differences in weight loss between IF and continuous energy restriction (CER) ○ Both found to be effective strategies for

weight loss within the obese population

● Heilbronn et. al (2005) noticed that participants’ hunger levels did not adapt to ADF, which may hinder the sustainability of the diet ○ People could add a small meal on the fasting

day to help make this diet more feasible over a long period of time

Discussion: Mechanisms ● Participants were not able to

consume enough calories on days they were eating to maintain their body weight, leading to weight loss

● Breaking fasting periods up with energy balance could decrease compensatory metabolic responses, which may improve the efficiency of weight loss (Byrne et al., 2017)

Discussion: Strengths & Limitations ● Strengths:

○ Experimental design (9/10 RCTs) ■ High internal validity &

reliability ○ All studies conducted within past

15 years ● Limitations:

○ 8/10 had small sample sizes (100 or less)

○ 6/10 had short interventions (3 months or less)

○ 3/10 studies the generalizability of the findings are limited

Discussion: Other Research ● Narrative review with 6 studies looked at

the effects of short-term IF found that IF is equivalent to CER in regard to weight loss in overweight & obese individuals and does not show any evidence of harmful effects (Harvie and Howell, 2017)

● A systematic review/meta-analysis of 6 studies with interventions =/> 6 months also found that there was no significant difference between IF & CER on weight loss (Headland, Clifton, Carter, & Keogh, 2016)

Conclusion ● ADF/IF is a safe & effective approach for short-term weight

reduction in obese ○ Even a 5-10% weight loss has been shown to have

various cardiometabolic improvements, like improved lipid levels, blood pressure, and glucose control and can help reduce healthcare costs (Ryan & Yockey, 2017)

● ADF/IF does not seem to have any adverse side effects in short-term

● Future research: ○ Larger & longer study duration (> 1 year) ○ Overweight/healthy BMI individuals with lipid/glucose

abnormalities, HTN, and/or high body fat percentage

References Bhutani, S., Klempel, M. C., Kroeger, C. M., Trepanowski, J. F., & Varady, K. A. (2013). Alternate day fasting and endurance exercise

combine to reduce body weight and favorably alter plasma lipids in obese humans. Obesity (Silver Spring, Md.), 21(7), 1370–1379. https://doi.org/10.1002/oby.20353

Bowen J, Brindal E, James-Martin G, Noakes M. (2018). Randomized trial of a high protein, partial meal replacement program with or without alternate day fasting: similar effects on weight loss, retention status, nutritional, metabolic, and behavioral outcomes. Nutrients, 10(9). https://doi.org/10.3390/nu10091145

Byrne, N. M., Sainsbury, A., King, N. A., Hills, A. P., & Wood, R. E. (2017). Intermittent energy restriction improves weight loss efficiency in obese men: The MATADOR study. International Journal of Obesity, 42(2), 129-138. doi:10.1038/ijo.2017.206

Catenacci, V. A., Pan, Z., Ostendorf, D., Brannon, S., Gozansky, W. S., Mattson, M. P., Martin, B., MacLean, P. S., Melanson, E. L., & Troy Donahoo, W. (2016). A randomized pilot study comparing zero-calorie alternate-day fasting to daily caloric restriction in adults with obesity. Obesity (Silver Spring, Md.), 24(9), 1874–1883. https://doi.org/10.1002/oby.21581

Centers of Disease Control and Prevention. (2020, April 10). Adult Overweight and Obesity. Retrieved May 28, 2020, from https://www.cdc.gov/obesity/adult/index.html

Eshghinia, S., & Mohammadzadeh, F. (2013). The effects of modified alternate-day fasting diet on weight loss and CAD risk factors in overweight and obese women. Journal of diabetes and metabolic disorders, 12(1), 4. https://doi.org/10.1186/2251-6581-12-4

Harvie M. & Howell A. (2017). Potential Benefits and Harms of Intermittent Energy Restriction and Intermittent Fasting Amongst Obese, Overweight and Normal Weight Subjects—A Narrative Review of Human and Animal Evidence. Behav. Sci., 7(1), 4. https://doi.org/10.3390/bs7010004

Harvie, M. N., Pegington, M., Mattson, M. P., Frystyk, J., Dillon, B., Evans, G., Cuzick, J., Jebb, S. A., Martin, B., Cutler, R. G., Son, T. G., Maudsley, S., Carlson, O. D., Egan, J. M., Flyvbjerg, A., & Howell, A. (2011). The effects of intermittent or continuous energy restriction on weight loss and metabolic disease risk markers: a randomized trial in young overweight women. International journal of obesity (2005), 35(5), 714–727. https://doi.org/10.1038/ijo.2010.171

References (con’t) Headland M., Clifton P.M., Carter S., & Keogh J.B. (2016). Weight-Loss Outcomes: A Systematic Review and Meta-Analysis of

Intermittent Energy Restriction Trials Lasting a Minimum of 6 Months. Nutrients, 8(6), 354. https://doi.org/10.3390/nu8060354 Heilbronn, L. K., Smith, S. R., Martin, C. K., Anton, S. D., & Ravussin, E. (2005). Alternate-day fasting in nonobese subjects: effects on

body weight, body composition, and energy metabolism. The American Journal of Clinical Nutrition, 81(1), 69–73. https://doi.org/10.1093/ajcn/81.1.69

Hoddy, K. K., Kroeger, C. M., Trepanowski, J. F., Barnosky, A., Bhutani, S., & Varady, K. A. (2014). Meal timing during alternate day fasting: Impact on body weight and cardiovascular disease risk in obese adults. Obesity (Silver Spring, Md.), 22(12), 2524–2531. https://doi.org/10.1002/oby.20909

Keogh, J. B., Pedersen, E., Petersen, K. S., & Clifton, P. M. (2014). Effects of intermittent compared to continuous energy restriction on short-term weight loss and long-term weight loss maintenance. Clinical obesity, 4(3), 150–156. https://doi.org/10.1111/cob.12052

Ryan, D. H., & Yockey, S. R. (2017). Weight Loss and Improvement in Comorbidity: Differences at 5%, 10%, 15%, and Over. Current obesity reports, 6(2), 187–194. https://doi.org/10.1007/s13679-017-0262-y

Trepanowski, J. F., Kroeger, C. M., Barnosky, A., Klempel, M. C., Bhutani, S., Hoddy, K. K., . . . Varady, K. A. (2017). Effect of alternate-day fasting on weight loss, weight maintenance, and cardioprotection among metabolically healthy obese adults. JAMA Internal Medicine, 177(7), 930. doi:10.1001/jamainternmed.2017.0936

Shelly Schick

A Review On The Effect Of Intermittent Fasting On Weight Loss

Andrews University

FDNT-680-999 Research Seminar

Summer 2020

Abstract

Obesity is a prominent disease in the United States, affecting millions of Americans and

costing billions of dollars in healthcare each year. Healthcare professionals recommend a

lifestyle change, including a healthy diet with calorie restriction along with daily physical

activity in order to promote weight loss. A relatively new approach to weight loss is intermittent

fasting, in which an individual goes a period of time without consuming calories. This literature

review was conducted via the databases EBSCO, Google Scholar, and PubMed and contains 10

experimental studies which looked at the relationship between intermittent fasting and body

weight. All 10 studies found that intermittent fasting led to weight loss, which ranged from 4.4

pounds to 31.0 pounds. Overall, intermittent fasting has been shown to be a safe and effective

way to lose weight, however long-term effects remain unknown.

Introduction

Obesity is a major health problem within the United States and leads to many different

chronic diseases and health conditions, like Hypertension, Dyslipidemia, Cardiovascular

Disease, Type 2 Diabetes Mellitus, Stroke, Sleep Apnea, Depression, and certain types of

cancers. This causes billions of dollars in medical expenses every year (Centers of Disease

Control and Prevention, 2020). Obesity is caused by genetic and environmental factors and

behaviors, like a poor diet and sedentary lifestyle. According to the Centers of Disease Control

and Prevention (CDC), from 2017-2018, 42.4% of adults in the United States were obese. A

person who has a body mass index (BMI) greater than or equal to 30.0 is considered obese

(Centers of Disease Control and Prevention, 2020).

Recently, Intermittent Fasting (IF) has become a popular method for people to try to lose

weight. However, IF it has been around for centuries; during Ramadan, Muslims fast between

sunrise and sunset, although they fast for religious purposes, rather than weight loss. There are

different versions of IF. One type is where a person fasts for a specific time frame (for example,

from 6:00 pm to 10:00 am) and then is allowed to eat for the remainder of the day (from 10:00

am to 6 pm). Another popular type is to fast for two days of the week and then eat normally the

other five days of the week. The fast can be defined as consuming no calories or consuming a

very low amount of calories (for example, 500 calories per day). With the recent increase in

popularity of IF, there have been many novel studies looking at IF and its benefits; the purpose

of this literature review was to conduct a literature review looking at the

relationship/effectiveness of IF on body weight (with a specific focus on weight loss) to see if IF

can help those who are obese lose weight.

Methodology

Literature Search

A literature review was conducted via the databases EBSCO, Google Scholar, and

PubMed by using the keywords: “intermittent fasting” “weight” “weight loss” “humans or

people” and “BMI.” Furthermore, the results were specified to be peer-reviewed and within the

past 15 years (from 2005-2020). The keyword “humans OR people” was used because only

studies conducted on humans were included in the review (as opposed to animals). After

reviewing the abstract of potential articles, the full-length text was reviewed to confirm inclusion

criteria of: (1) An experimental study design, (2) A study population of adults, (3) An exposure

of intermittent fasting, and (4) An outcome of body weight. Any study that was conducted on

animals, or any study that was conducted more than 15 years ago (before 2005) was excluded

from this analysis.

Data extraction

10 experimental studies (nine randomized control trials and one quasi-experimental) were

included in the final analysis, all of which investigated the association between IF on body

weight within the adult population. The 10 sources included in this review were: Bhutani,

Klempel, Kroeger, Trepanowski, & Varady (2013), Bowen, Brindal, James-Martin, & Noakes

(2018), Byrne, Sainsbury, King, Hills, & Wood (2017), Catenacci et al. (2016), Eshghinia &

Mohammadzadeh (2013), Harvie et al. (2011), Heilbronn, Smith, Martin, Anton, & Ravussin

(2005), Hoddy et al. (2014), Keogh, Pedersen, Petersen, & Clifton (2014), and Trepanowski et

al. (2017). Many of the studies looked at other outcomes, like changes in waist circumference,

insulin sensitivity, blood pressure, and lipid levels (specifically, HDL cholesterol, LDL

cholesterol, and triglycerides), however only information pertaining to body weight was included

in this analysis. The specific information taken from these studies included the main objective of

each study, the type exposure/intervention used in each study, the main results/findings and

conclusions (specifically findings related to body weight), as well as study limitations.

Results

This literature review included 10 experimental studies. Table 1.1 shows the study

design, main objective, type of exposure used and outcome measured within all of the articles

reviewed. Altogether, the intervention time periods ranged from six weeks to six months. Each

study had its own definition for what a “fasting” day looked like; one study defined its fasting

day by not consuming any calories, while most studies defined fasting days by allowing

participants to eat a certain percentage of their calorie needs (for example, 25% of their daily

calorie/energy needs).

Table 1.2 explains the main finding(s), conclusion(s), and the limitations of the studies

reviewed. All of the studies found that following an IF diet protocol caused a reduction in

weight; the weight loss for IF ranged from 4.4 pounds to 31.0 pounds.

Table 1.3 displays the demographics of the study population, as well as any comorbidities

in the study population. The sample size of the study population ranged from 15 to 162

participants. Nine out of the 10 studies included study population of participants who were obese

and one study did not have any comorbidities in its study population (Heilbronn et al., 2005).

In general, it is evident that more research needs to be conducted before recommending

IF as a means to lose weight since long-term studies on IF have yet to be conducted, although the

research does not present any harm in metabolic function in the short-term.

Discussion

Overall, most of the studies did not find any significant differences in weight loss

between IF and continuous energy restriction (CER)— both were found to be effective strategies

for weight loss within the obese population. However, there needs to be longer and larger studies

looking at the long-term effects of IF. For example, Heilbronn and colleagues (2005) noticed that

participants’ hunger levels did not adapt to alternate day fasting (ADF), which may hinder the

sustainability of the diet. The researchers suggest that people could add a small meal on the

fasting day to help make this diet more feasible over a long period of time.

All of the studies investigated in this literature review found changes in weight,

specifically weight reduction, when following a IF diet protocol. However, the amount of weight

loss varied from article to article. These differences in amount of weight loss between the studies

may be due to the differences in study durations and/or the differences in IF diet protocol. For

example, some studies had two or three fasting days each week where participants consumed

25-30% of their daily energy needs (Bhutani, 2013, Eshghinia, 2013, Heilbronn, 2005, Hoddy,

2014, and Trepanowski, 2017), while another study had participants fast for one week (-1,314.5

calories per day) followed by a regular week (Keogh, 2014).

Several other peer-reviewed articles have found similar findings seen in this literature

review. For example, in a narrative review conducted by Harvie and Howell (2017) included six

studies looking at the effects of short-term IF. The researchers found that IF is equivalent to CER

in regard to weight loss in overweight and obese individuals and does not show any evidence of

harmful effects. Furthermore, a systematic review and meta-analysis of nine studies with

interventions equal to or longer than six months also found that there was no significant

difference between IF and CER on weight loss (Headland, Clifton, Carter, & Keogh, 2016).

Mechanisms

The likely mechanism explaining the results found in this literature review suggests that

participants were not able to consume enough calories on days they were eating (as opposed to

fasting) to maintain their body weight, leading to weight loss. Furthermore, Byrne and colleagues

(2017) suggest that breaking fasting periods up with energy balance could decrease

compensatory metabolic responses, which may improve the efficiency of weight loss.

Strengths and Limitations

Like all studies, there were various strengths and limitations regarding the studies

reviewed. In regard to strengths, all of the studies reviewed were an experimental design, with

nine out of the 10 being randomized control trials (the gold standard for a research design); this

is a major strength regarding this literature review because experimental designs have high

internal validity and reliability. Furthermore, all of the studies reviewed were conducted within

the past 15 years, which means that the findings are from the most up-to-date data within the

field.

However, there were also various limitations that need to be addressed. First off, many of

the studies had a sample size of 100 or less (Bhutani et al. (2013), Byrne et al. (2017), Catenacci

et al. (2016), Eshghinia & Mohammadzadeh (2013), Heilbronn et al. (2005), Hoddy et al. (2014),

Keogh et al. (2014), and Trepanowski et al. (2017). Additionally some studies had short

intervention time frames of equal to or less than three months (Bhutani et al. (2013), Catenacci et

al. (2016), Eshghinia & Mohammadzadeh (2013), Heilbronn et al. (2005), Hoddy et al. (2014),

and Keogh et al. (2014)). Finally, in some of the studies, the generalizability of the findings were

limited (Bhutani et al. (2013), Catenacci et al. (2016), and Trepanowski et al. (2017)).

Conclusion

In conclusion, this review shows support that IF can aid in short-term weight loss,

especially in those who are obese. There seems to be no short-term adverse side effects

connected with IF/ADF. Researchers concluded that ADF can be as safe and effective as CER in

regard to losing weight; even a 5-10% weight loss has been shown to have various

cardiometabolic improvements, like improved lipid levels, blood pressure, and glucose control

and can help reduce healthcare costs (Ryan & Yockey, 2017).

Since many of the studies have short intervention time frames (less than one year), the

long-term health effects and effectiveness in weight loss/maintenance regarding IF remains

unknown. Future research studies looking at the association of IF and weight loss should have

longer durations (greater than one year) and larger sample sizes (greater than 100 participants) to

assess sustainability, as well as the long-term effects of IF. Additionally, there is limited

evidence looking at the impact of IF on weight loss in overweight individuals since most of the

studies conducted look at obese individuals. Future research should include a study population

with overweight individuals and/or individuals with a healthy BMI with other health

abnormalities (for example, a high body fat percentage, hypertension, abnormal glucose and/or

lipid panel levels) to assess if IF helps improve these cardiometabolic risk factors.

References

Bhutani, S., Klempel, M. C., Kroeger, C. M., Trepanowski, J. F., & Varady, K. A. (2013).

Alternate day fasting and endurance exercise combine to reduce body weight and

favorably alter plasma lipids in obese humans. ​Obesity​ (Silver Spring, Md.), 21(7),

1370–1379. ​https://doi.org/10.1002/oby.20353

Bowen J, Brindal E, James-Martin G, Noakes M. (2018). Randomized trial of a high protein,

partial meal replacement program with or without alternate day fasting: similar effects on

weight loss, retention status, nutritional, metabolic, and behavioral outcomes. ​Nutrients​,

10(9). ​https://doi.org/10.3390/nu10091145

Byrne, N. M., Sainsbury, A., King, N. A., Hills, A. P., & Wood, R. E. (2017). Intermittent

energy restriction improves weight loss efficiency in obese men: The MATADOR study.

International Journal of Obesity​, 42(2), 129-138. doi:10.1038/ijo.2017.206

Catenacci, V. A., Pan, Z., Ostendorf, D., Brannon, S., Gozansky, W. S., Mattson, M. P., Martin,

B., MacLean, P. S., Melanson, E. L., & Troy Donahoo, W. (2016). A randomized pilot

study comparing zero-calorie alternate-day fasting to daily caloric restriction in adults

with obesity. ​Obesity​ (Silver Spring, Md.), 24(9), 1874–1883.

https://doi.org/10.1002/oby.21581

Centers of Disease Control and Prevention. (2020, April 10). Adult Overweight and Obesity.

Retrieved May 28, 2020, from https://www.cdc.gov/obesity/adult/index.html

Eshghinia, S., & Mohammadzadeh, F. (2013). The effects of modified alternate-day fasting diet

on weight loss and CAD risk factors in overweight and obese women. ​Journal of diabetes

and metabolic disorders​, 12(1), 4. https://doi.org/10.1186/2251-6581-12-4

Harvie M. & Howell A. (2017). Potential Benefits and Harms of Intermittent Energy Restriction

and Intermittent Fasting Amongst Obese, Overweight and Normal Weight Subjects—A

Narrative Review of Human and Animal Evidence. ​Behav. Sci., ​7(1), 4.

https://doi.org/10.3390/bs7010004

Harvie, M. N., Pegington, M., Mattson, M. P., Frystyk, J., Dillon, B., Evans, G., Cuzick, J., Jebb,

S. A., Martin, B., Cutler, R. G., Son, T. G., Maudsley, S., Carlson, O. D., Egan, J. M.,

Flyvbjerg, A., & Howell, A. (2011). The effects of intermittent or continuous energy

restriction on weight loss and metabolic disease risk markers: a randomized trial in young

overweight women. ​International journal of obesity​ (2005), 35(5), 714–727.

https://doi.org/10.1038/ijo.2010.171

Headland M., Clifton P.M., Carter S., & Keogh J.B. (2016). Weight-Loss Outcomes: A

Systematic Review and Meta-Analysis of Intermittent Energy Restriction Trials Lasting a

Minimum of 6 Months. ​Nutrients, ​8(6), 354. ​https://doi.org/10.3390/nu8060354

Heilbronn, L. K., Smith, S. R., Martin, C. K., Anton, S. D., & Ravussin, E. (2005). Alternate-day

fasting in nonobese subjects: effects on body weight, body composition, and energy

metabolism. ​The American Journal of Clinical Nutrition​, 81(1), 69–73.

https://doi.org/10.1093/ajcn/81.1.69

Hoddy, K. K., Kroeger, C. M., Trepanowski, J. F., Barnosky, A., Bhutani, S., & Varady, K. A.

(2014). Meal timing during alternate day fasting: Impact on body weight and

cardiovascular disease risk in obese adults. ​Obesity​ (Silver Spring, Md.), 22(12),

2524–2531. https://doi.org/10.1002/oby.20909

Keogh, J. B., Pedersen, E., Petersen, K. S., & Clifton, P. M. (2014). Effects of intermittent

compared to continuous energy restriction on short-term weight loss and long-term

weight loss maintenance. ​Clinical obesity​, 4(3), 150–156.

https://doi.org/10.1111/cob.12052

Ryan, D. H., & Yockey, S. R. (2017). Weight Loss and Improvement in Comorbidity:

Differences at 5%, 10%, 15%, and Over. ​Current obesity reports​, ​6​(2), 187–194.

https://doi.org/10.1007/s13679-017-0262-y

Trepanowski, J. F., Kroeger, C. M., Barnosky, A., Klempel, M. C., Bhutani, S., Hoddy, K. K., . .

. Varady, K. A. (2017). Effect of alternate-day fasting on weight loss, weight

maintenance, and cardioprotection among metabolically healthy obese adults. ​JAMA

Internal Medicine​, 177(7), 930. doi:10.1001/jamainternmed.2017.0936

Appendices Table 1.1

Author (year)

Study Design

Main Objective Exposure Outcome Measured

Type of Analysis (α & p-value)

Bhutani (2013)

Randomized Control Trial

To investigate whether ADF with exercise has a greater effect on body composition compared to ADF or exercise alone

ADF plus exercise vs. exercise alone vs. ADF alone

Body weight

One-way ANOVA at baseline; repeated-measures ANOVA for within-group differences; Intention-to-treat analysis (α: 0.05; p: <0.05)

Bowen (2018)

Randomized Control Trial

To compare an energy restriction with ADF to a high-protein, meal replacement program with daily energy restriction (DER) on weight loss

High-protein, meal replacement program with DER vs. energy restriction with ADF

Body weight

Mixed effects linear models (α: 0.05; p: <0.05)

Byrne (2017)

Randomized Control Trial

To determine whether intermittent energy restriction (IER) had a greater impact on weight loss efficiency in comparison to continuous energy restriction (CER)

IER vs. CER Weight loss efficiency

Mixed model repeated measures analyses (α: 0.05; p: <0.05)

Catenacci (2016)

Randomized Control Trial

To compare the effects of ADF versus a moderate daily caloric restriction (CR) on weight status

Zero-calorie ADF vs. calorie restriction (-400 kcal/day)

Body weight

Linear mixed-effects model; Independent-sampl es ​t ​-tests (α: 0.05; p: <0.05)

Eshghinia (2013)

Quasi- experimenta l

To evaluate the effects of a modified ADF on body weight in obese women

Alternate-day fasting diet

Body weight

Paired ​T​-test (α: 0.05; p: <0.05)

Harvie (2011)

Randomized Control Trial

To compare the effectiveness & practicality of IER vs. CER on weight loss

IER vs. CER Weight loss

Paired ​t​-tests at baseline & LOCF analysis at 6

months (α: 0.05; p: <0.05)

Heilbronn (2005)

Randomized Control Trial

To examine if ADF is a practical method of dietary restriction for weight loss in non-obese individuals

ADF Body weight

One- & two-factor repeated-measures analysis of variance (α: 0.05; p: <0.05)

Hoddy (2014)

Randomized Control Trial

To compare the effects of ADF with three meal times on body weight

ADF with three meal times

Body weight

One way ANOVA, Tukey's ​post hoc test, & a paired t​-test (α: 0.05; p: <0.05)

Keogh (2014)

Randomized Control Trial

To investigate the effect of IER versus CER on weight loss

IER vs. CER Body weight

Independent samples t-test at baseline; repeated-measures ANOVA (α: 0.05; p: <0.05)

Trepanowski (2017)

Randomized Control Trial

To compare the effects of ADF vs. a DER on weight loss

ADF vs. DER Weight loss

Independent-sampl es ​t​ test; a linear mixed model (α: 0.05; p: <0.05)

Table 1.2

Author (year)

Main Finding(s) Conclusion(s) Study Limitations

Bhutani (2013)

Body weight was reduced in all of the intervention groups after 12 weeks (​P ​< 0.05). Body weight decreased by 6 ± 4 kg, 3 ± 1 kg, and 1 ± 0 kg in the ADF plus exercise, ADF, and exercise groups, respectively

ADF plus exercise produces greater amount of weight loss compared to ADF or exercise alone

Short intervention time frame (12 weeks); used BIA to measure fat mass & fat free mass instead of dual-energy X-ray absorptiometry (DXA); participants were only from the University of Illinois, Chicago campus (cannot generalized results); flawed randomization procedure

Bowen (2018)

There was a statistically significant decrease in body weight over time (​p​ < 0.001); At week 16 of the intervention, weight decreased by 10.7 ± 0.5 kg & −11.2 ± 0.6 kg in the ADF + DER group and the DER group, respectively (no significant difference between groups)

Both a high-protein, meal replacement program with DER & a energy restriction with ADF support weight loss

No biological data at 6 months; no long-term follow up; small number of male participants; no measurement for energy expenditure & physical activity monitoring

Byrne (2017) The IER group lost more weight compared to the CER group (14.1±5.6 vs 9.1±2.9 kg; P<0.001); Both groups regained weight after the 6-month follow-up (IER: 3.5±5.9 vs. CER: 5.9±4.7 kg; ​P​=0.24)

IER prodcued a higher amount of weight and fat loss.

Attrition in study population; small weight loss during baseline period; no measurements for body composition or resting energy expenditure during energy balance blocks in the IER group

Catenacci (2016)

At week 8, the ADF group had a greater energy deficient of 376 kcal/day compared to the CR group; however, no significant changes in weight were seen between the two groups (mean ±SE; ADF -8.2 ± 0.9 kg, CR -7.1 ± 1.0 kg). Finally, after week 24 of unsupervised follow-up, no significant differences in weight regain were seen

ADF & CR produced similar amount of weight loss after the 8 weeks

Pilot study; small sample size; randomization was arranged by sex; small male percentage; no measurements on physical activity; results cannot be generalized

Eshghinia (2013)

ADF significantly reduced body weight from 84.3 ± 11.44 kg to 78.3 ± 10.18 kg (P < 0.001)

Short-term ADF is an effective intervention for weight loss & reducing CAD risk in obese individuals

No control groups; small sample size; short intervention time frame (<8 weeks)

Harvie (2011)

IER & CER are equally effective (but not significantly different) for weight loss. The average weight change was -6.4 (-7.9 to -4.8) kg for IER and -5.6 (-6.9 to -4.4) kg for CER (P=0.4)

IER & CER are both effective ways to lose weight and produce similar results; IER could be used as an alternative to CER for weight & disease risk reduction

Did not assess long-term adherence to IER

Heilbronn (2005)

Participants significantly reduced their initial body weight by 2.5 ± 0.5% (​P​ < 0.001)

ADF is a practical method of dietary restriction for weight loss in non-obese individuals

Small sample size (16), short intervention time frame (22 days)

Hoddy (2014)

Body weight (​P ​ < 0.001) reduction included: ADF-Lunch: 3.5 ± 0.4 kg, ADF-Dinner 4.1 ± 0.5 kg, ADF-Small Meal 4.0 ± 0.5 kg, but there were no significant differences between groups

Consuming the fast day meal at dinner, lunch, or small meals all produce similar weight loss results, as well as cardio-protective benefits; the flexibility to choose the time of the fast day meal could increase tolerability & sustainability for adherence to ADF

No “breakfast” group to look at effects of consuming the fast day meal between 6:00-8:00am.; only 80% of data for participants’ activity in intervention group were collected because of malfunctioning activity monitors; adherence to fasting was self-reported; no control group

Keogh (2014)

Weight decreased significantly with time (P < 0.001). There was no significant difference in regard to weight loss between CER and IER after 8 weeks (-3.2 ± 2.1 kg for CER and -2.0 ± 1.9 kg for IER; ​P ​ = 0.06) or after 12 months (-4.2 ± 5.6 kg for CER and -2.1 ± 3.8 kg for IER; ​P  = 0.19); Weight loss between weeks 8-52 was -0.7 ± 49 kg for CER and -1± 1.1 kg for IER; ​P  = 0.6

Intermittent dieting is as effective as a continuous caloric restriction over a 8 week time frame, as well as for weight loss maintenance at 1 year

60% of participants dropped out (limited power to the study); protocol in the study is different than for IF & ADF

Trepanowski (2017)

At 6 months, the average weight loss between the two groups (ADF vs. DER) was not significantly different (–6.8% [–9.1% to –4.5%] vs. –6.8% [–9.1% to –4.6%], respectively). These same findings were seen after 12 months as well (–6.0% [–8.5% to –3.6%] vs. –5.3% [–7.6% to –3.0%], respectively). No significant weight changes were seen in the control group. Overall, the participants in the ADF group consumed more calories than prescribed on fasting days, however they consumed less calories than prescribed on feasting days. Participants in the DER group met their prescribed caloric intake goals.

ADF did not produce a greater weight loss compared to DER

Short maintenance phase (6 weeks); control group did not receive food or counseling and received less attention; high dropout rate (this decreased the power); generalizability of the study is limited; study population was metabolically healthy obese individuals (improvements might have been greater in metabolically unhealthy individuals)

Table 1.3

Author (year) Demographics of the study population (n= number of participants)

Bhutani (2013) n= 64; Comorbidities in study population: obesity Average age (years): 44.5 (range: 25-65) % male: 3.6; % female: 96.4

Bowen (2018) n= 162; Comorbidities in study population: obesity Average age (years): 40 (range: 25-60) % male: 19; % female: 81

Byrne (2017) n= 51; Comorbidities in study population: obesity Average age (years): 40 (range: 25-54) % male: 100; % female: 0

Catenacci (2016) n= 26; Comorbidities in study population: obesity Average age (years): 41.1 (range: 18-55) % male: 24; % female: 76

Eshghinia (2013) n= 15; Comorbidities in study population: obesity Average age (years): 33.5 (range: 20-45) % male: 0; % female: 100

Harvie (2011) n= 107; Comorbidities in study population: obesity Average age (years): 40 (range: 30-45) % male: 0; % female: 100

Heilbronn (2005) n= 16; Comorbidities in study population: none Average age (years): 32 (range: 23-53) % male: 50; % female: 50

Hoddy (2014) n= 74; Comorbidities in study population: obesity Average age (years): 45 (range: 25-65) % male: 15; % female: 85

Keogh (2014) n= 36; Comorbidities in study population: obesity Average age (years): 60.2 % male: 0; % female: 100

Trepanowski (2017) n= 100; Comorbidities in study population: obesity Average age (years): 44 (range:18-65) % male: 14; % female: 86

SySllyalblaubsus FDNT680

Page 1

Dr. Dixon Anjejo

FDNT 680-999: Research Seminar

Spring 2020

FDNT 680-999: Research Seminar

Spring 2025

Dr. Dixon Anjejo Assistant: Eugenie Mukamunana

FDNT680 Syllabus

Page 2

Spring 2025

FDNT 680: RESEARCH SEMINAR (1 Credit Hour)

Course Descriptions

The Research Seminar allows MPH students to prepare and present scientific information on

nutrition, wellness, health promotion, and health education to MPH/MS students and/or public

health professionals.

Instructor Contact

Professor: Dixon Anjejo, MPH, DrPH

Assistant: Eugenie Mukamunana

Office: Marsh Hall 313

Office Hours: Wednesdays & Thursdays 12 pm – 2 pm

EST Email: [email protected]

Office Phone: 269-471-3386

Interactive Online Format

This course follows an interactive online format delivered online through Learning Hub

https://learninghub.andrews.edu/. You are expected to log in regularly during the course to

participate in the online discussions, post research documents, and communicate with classmates

and the instructor. The technical requirements include weekly access to an internet connection

(DSL, LAN, or cable connection desirable). Please plan accordingly. Your username and

password are your Andrews’ username and password. You must activate your username and

password to access Learning Hub:

https://vault.andrews.edu/vault/pages/activation/information.jsp.

Username and password

assistance

[email protected] (269) 471-6016

Bookstore http://bookstore.mbsdirect.net/andrews.htm

Library – Silas Marques,

Off-campus Services

Librarian

https://www.andrews.edu/library/offcamp.html 269-471-6263

Technical assistance with

Learning Hub

[email protected] (269) 471-3960

Exam requests and

proctoring assistance

[email protected] (269) 471-6566

FDNT680 Syllabus

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Course Methods and Delivery Methods of Instruction

Methods of instruction include assigned readings from articles in peer-reviewed journals related

to the students’ Interactive Learning Experience (ILE), the course material and selected videos, as

well as feedback from peers and instructor. This course is delivered online through Learning Hub

at http://learninghub.andrews.edu. Your username and password are your Andrews’ username and

password. You need to activate your username and password to access LearningHub. Please do

this online here: https://vault.andrews.edu/vault/pages/activation/information.jsp if you haven’t

already. (269) 471- 6016 or email [email protected] if you need assistance. If you need

technical assistance at any time during the course or to report a problem with Learning Hub,

please email [email protected] or call 269-471-3960.

Part 1: Course Objectives & Schedule

FDNT 680 Research Seminar meets the following requirements:

Course Competencies for CEPH Accreditation

The course reinforces the following foundational and concentration competencies to meet the

CEPH requirements:

1. Review literature of evidence-based education initiatives designed to address diet and

lifestyle issues focusing on preventing chronic diseases and health promotion by applying

knowledge acquired from courses emphasizing vegetarian nutrition and physical activities.

2. Review the literature on a wellness program for a specific population to decrease the

prevalence and incidence of chronic disease related to inactivity using relevant

evidence-based recommendations on physical activity.

3. Review the literature on a health and wellness education initiative/program to educate

and motivate people about health.

4. Review literature on developing and evaluating research (methods) designs using

public health methodology, biostatistics, and/or epidemiology to address research

questions in public health.

5. Systematically and critically evaluate peer-reviewed research articles on nutritional

wellness, physical activities, and general lifestyle.

6. Apply epidemiological methods to the breadth of settings and situations in public

health practice

7. Select quantitative and qualitative data collection methods appropriate for a given

public health context

8. Analyze quantitative and qualitative data using biostatistics, informatics, computer-

based programming and software as appropriate

FDNT680 Syllabus

Page 4

9. Interpret results of data analysis for public health research, policy or practice

10. Select communication strategies for different audiences and sectors

11. Communicate audience-appropriate public health content, both in writing and

through oral presentation

Course Learning Outcomes (Objectives) (LO) from Andrews University:

1. Learn how to search scientific data using different library databases.

2. Learn how to select and gather relevant and sound scientific data.

3. Critically analyze and evaluate scientific literature.

4. Summarize and interpret relevant scientific literature.

5. Create a formal scientific PowerPoint presentation.

6. Present scientific information for graduate level and professional audiences.

7. Enhance verbal and written communication skills.

8. Lead a research discussion using data-backed evidence to defend own conclusions.

FDNT680 Syllabus

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Course Schedule

Week Activity Assignment CC LO

Week 1

Choose your research topic. This topic may be

something you choose to explore further in your

ILE or other culminating research activity. Discuss

your topic with the course instructor. The instructor

must approve the topic before you post.

Post your

research topic.

1, 2

1,2

Week 2

Search scientific databases (Pub Med, Science

Direct, EBSCO, Google Scholar, etc.). Create an

annotated bibliography that includes at least 12

articles relevant to your topic. Ideally, those

papers should be the backbone for the literature

review section of your Interactive Learning

Experience (ILE) or Research Project.

Post an annotated

bibliography with

at least 12

relevant articles

to your topic.

1,2, 3

1,2

Week 3-5

Critically and systematically review the 12

selected articles from week 2. Please remember

how you did your review in Research Methods

and other courses like Current Issues in

Nutrition.

Submit

your

reviews.

1, 2

3

Week 6 Read the 12 selected articles. Write a (200-250

words) abstract of your reviews.

Post your revised

title and the

abstract.

1, 2 3

Week 7

Create and prepare the PowerPoint slides for your

oral presentation of the reviews. You may consult

with your instructor for further guidance.

Present your

research via

Zoom

conference.

8,

9,

10

5,6,7,8

Week 8

Oral presentations.

Present your

research via

Zoom conference.

Upload the

research

presentation

slides and the

research paper

after revising

based on instructor

feedback.

8, 9, 10

5, 6,7,8

FDNT680 Syllabus

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KEY: CC – Concentration Competency

LO – Course Learning Outcome

Part 2: Course Requirements

Topic Selection: 5%

Bibliography: 10%

Critical and Systematic of Literature 35%

Students are required to prepare a focused literature review paper and a PowerPoint presentation.

Then, write a short abstract summarizing the presentation. See the rubrics for the evaluation in

the syllabus appendix. In addition, the student will research and critically review the scientific

literature to prepare a 30-minute PowerPoint culminating presentation summarizing a selected

topic of nutrition and wellness, highlighting the most salient finding of their research, and

critically analyzing the literature used for the research presentation. In addition, each student will

prepare a 4-6 research paper summarizing the key research topic and critically analyzing the data

of the research topic articles.

The research topic must be approved in advance by the instructor early in the course. NOTE: To

expedite the completion of the ILE, each student can research the literature relevant to their ILE

project. The research seminar can help students meet the course requirements and, at the same

time, can be used to gather background information relevant to the ILE.

The content of the literature review paper:

1) Title.

2) Abstract.

3) Literature review—focused systematic and critical review

4) Summary of results.

5) Discussion

6) Conclusion

7) Recommendations

Timely Submission of Assignments: 5%

The assignments must be submitted before or on the due date. Students who submit past the due date

will lose points.

FDNT680 Syllabus

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PowerPoint Presentation-Instructor Evaluation 45%

The PowerPoint presentations follow a research conference format. The abstracts will be printed

and circulated to all participants in the presentation. The instructor will announce the conference

time after discussing it in class. Each student will consult with the instructor at least once to review

their presentation before presenting. As the rubric indicates, faculty will react to several aspects of

each presentation. This is an interactive presentation, and the presenters will have the opportunity

to answer questions about their research and to receive feedback from students and faculty. This

culminating presentation will enhance the presentation skills of each participant. The culminating

presentation will target graduate public health students and health professionals, not lay audiences.

Therefore, we expect the student to demonstrate an in-depth understanding of the topic presented.

The presentation should provide the following:

• a clear overview of the topic

• a solid and relevant background about the topic being presented and key findings of

the papers reviewed in the selected research area

• methodological issues that might explain discrepancies between similar studies

• gaps in knowledge

• Recommendations for future research in the topic of study

Students must consult with the course instructor before their oral

presentations.

FDNT680 Syllabus

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Credit Hour and Commitment

This course is offered for 1 credit; therefore, it is expected that you will spend averagely 22 hours

per week during the 8-week duration of this class. There are no quizzes or exams for this course.

MS students will take an additional credit of Research Seminar the following semester. The

additional credit will focus on clinical aspects.

Part 4: Grading Policy

Key Assignments and Evaluations

Percent

%

Description

5% Topic of the Review

10% Annotated Bibliography

35% Critical and systematic review of Literature - This literature review can be

used in the student’s ILE research project.

Peer Evaluation - Average of all the peer evaluations for each presentation

45% PowerPoint Presentation - Instructor Evaluation - Course instructor

evaluation

4% Timely submission of assignments

1% Course Evaluation

100% Total Percent Possible

Letter Grade Assignment

Letter Grade Percentage

A 94-100%

A- 90-93%

B+ 88-89%

B 83-87%

B- 80-82%

C+ 78-79%

C 73-77%

C- 70-72%

D 60-69%

F 0-59%

FDNT680 Syllabus

Page 9

Completing Assignments

All assignments for this course will be submitted electronically through Learning Hub unless

otherwise instructed.

Part 5: Course Policies

Late Work

Each student is expected to turn in all the assignments promptly. The deadline for submissions

and reviews is Sunday at midnight the following week. If I need to modify those deadlines, I will

notify the students.

Withdrawal and Incomplete Policies

The current withdrawal policy can be found online at

http://www.andrews.edu/distance/students/withdrawal.html. The incomplete policy is found online

at http://www.andrews.edu/weblmsc/moodle/public/incompletes.html.

ACADEMIC INTEGRITY:

“Andrews University, as a Seventh-day Adventist institution, expects students to demonstrate the

ability to think clearly and exhibit personal moral integrity in every sphere of life. Honesty in all

academic matters is a vital component of personal integrity. Breaches in academic integrity

principles are taken seriously by the University. Acts of academic dishonesty, as described in the

University Bulletin, are subject to incremental disciplinary penalties with redemptive intent. Such

acts are tracked in the office of the Provost. Repeated and/or serious offenses will be referred to

the Committee on Academic Integrity for further recommendations on penalties.”

ARTIFICIAL INTELLIGENCE (AI) USE POLICY

This policy applies to generative AI tools like ChatGPT, Elicit, etc. Suppose you include material generated

by an AI program in your work; it must be cited as you would with any other reference material,

considering the reference quality, which might be subpar. No more than 25% of an assignment should

consist of AI-created content. For guidance on proper APA formatting for these citations, please refer to the

article in the link below How to cite ChatGPT

In this course my policy will be that any student who:

(a) submits work done by another student as their own

(b) engages in or contributes to plagiarism

(c) engages in or contributes to cheating on a test or assignment

(d) deliberately misleads the instructor through falsehood (i.e. lying)

(e) falsifies data etc.

The student may receive a grade of zero for that assignment. Depending on the severity of the

offense, and at the discretion of the instructor, further disciplinary measures may be pursued at the

college level. Repeat offenses may result in a zero for the course. Please note again that all

FDNT680 Syllabus

Page 10

instances of academic honesty must and will be reported to the office of the Provost, where a

record will be kept on file. As noted above, the University uses these records to track repeat

offenders

FDNT680 Syllabus

Page 11

In order to protect academic integrity the following policies will be followed:

(a) A student may be given an oral examination on any assignment at any time.

(b) All electronic equipment must be turned off and placed out of sight during tests. The

presence of active electronic equipment may be considered as an attempt to engage in

cheating. (c) The provision of materials used in plagiarism or cheating will be

considered as serious an offense as the plagiarism or cheating itself.

Plagiarism is defined as:

(a) The use of works produced by another without indicating that a source is being copied

and without citation

(b) The use of ideas produced by another without citation

(c) The use of a structure for making an argument or describing a finding without citation

(d) Any of the above, no matter what the type of material that is used – drawings,

written text, and spoken presentations, may all be plagiarism

EMAIL ETIQUETEE

• Answer ASAP – within 24 to 48 hours. A month in email feels like 20 years. A day feels

like a week. Not returning emails or phone calls is communicating that you view the caller

or sender as unimportant. Be brief in your communication – Most people don’t

thoroughly read anything much longer than a memo.

• Don’t forget punctuation, capitalization, and spelling – How many emails have you

received with poor spelling or grammar? How many have you sent with poor spelling and

grammar? It sends what communication theorists call a meta-message or “message around

a message.” The meta message is that you don’t care enough to proofread. Use the spell-

check feature.

• Respond to the sender’s question when returning the email - Isn’t it frustrating when

you purposefully ask a question via email only to ignore it? You then have to resubmit

the question in the next email. Use a greeting and a salutation – They are friendlier.

Every e-mail sounds better with a “Dear Bill” and a “Thanks, Sue.” The greeting and the

closing set an important tone for your message.

• Email is a written work – There is a finality to an email message. Never use email to

send sensitive information.

USING TECHNOLOGY:

Many assignments in this class will require you to complete assignments on computers or the

internet. If you submit an assignment electronically, be sure to keep a backup copy. At a

minimum, this should be an electronic copy; however, you may find it to your advantage to print

a copy for your records.

EMERGENCY PROTOCOLS

FDNT680 Syllabus

Page 12

Andrews University takes the safety of its student seriously. Signs identifying emergency protocol

are posted throughout buildings. Instructors will provide guidance and direction to students in the

classroom in the event of an emergency affecting that specific location. It is important that you

follow these instructions and stay with your instructor during any evacuation or sheltering

emergency.

DISABILITY:

Andrews University accepts and appreciates diversity in its students, including students with

disabilities. Accordingly, students with documented disabilities are encouraged to inform the

University of their disability and enter into a dialogue regarding ways in which the University

might reasonably accommodate them. If you qualify for the accommodations under the Americans

with Disabilities Act, please see the instructor as soon as possible for referral and assistance in

arranging such accommodations.

Academic Accommodations

Students who require accommodations may request an academic adjustment as follows:

1. Read the Andrews University Disability Accommodation information at

https://www.andrews.edu/services/sscenter/disability/

2. Download and fill in the disability form at

http://www.andrews.edu/services/sscenter/disability/accommodationsreqform.pdf .

Preferably type answers. To save a digital copy, 1) print to file and save or 2) print and

scan. Email the completed form and disability documentation (if any) to

[email protected] or fax it to 269471-8407.

3. Email [email protected] to inform the School of Distance Education that a

disability has been reported to Student Success.

4. Please note that you cannot revise a paper you have not written. If you fail to turn in an

assigned essay, you cannot submit a revision of that paper. You are encouraged to revise

any paper with which you are not satisfied. Unfortunately, you can only revise your

essays. You cannot revise discussion board postings, journal entries, midterm exam, or

final exam.

Commit to Integrity

As a student in this course (and at this university) you are expected to maintain high degrees of

professionalism, commitment to active learning and participation in this class and also integrity in

your behavior in and out of the classroom.

Commit to Excellence

You deserve a standing ovation based on your decision to enroll in, and effectively complete this

course.

FDNT680 Syllabus

Page 13

Along with your pledge of “commitment to Integrity” you are expected to adhere to a

“Commitment to excellence.” Andrews University has established high academic standards that

will truly enhance your writing and communication skills across the disciplines and in diverse

milieu with many discourse communities in the workplace.

Honesty

Using the work of another student or allowing work to be used by another student jeopardizes not

only the teacher-student relationship but also the student’s academic standing. Lessons may be

discussed with other students, tutors may help to guide a student’s work, and textbooks,

encyclopedias and other resource materials may be used for additional assistance, but the actual

response must be the student’s own work. A student who gives information to another student to

be used in a dishonest way is equally guilty of dishonesty.

“Andrews University, as a Seventh-day Adventist institution, expects students to demonstrate the

ability to think clearly and exhibit personal moral integrity in every sphere of life. Honesty in all

academic matters is a vital component of personal integrity. Breaches in academic integrity

principles are taken seriously by the University. Acts of academic dishonesty as described in the

University Bulletin are subject to incremental disciplinary penalties with redemptive intent. Such

acts are tracked in the office of the Provost. Repeated and/or serious offenses will be referred to

the Committee on Academic Integrity for further recommendations on penalties.”

In this course my policy will be that any student who:

(a) submits work done by another student as their own

(b) engages in or contributes to plagiarism

(c) engages in or contributes to cheating on a test or assignment

(d) deliberately misleads the instructor through falsehood (i.e., lying) (e)

falsifies that may receive a grade of zero for that assignment.

Depending on the severity of the offense and at the instructor's discretion, further disciplinary

measures may be pursued at the college level. Repeat offenses may result in a zero for the course.

Please note again that all instances of academic honesty must and will be reported to the office of

the Provost, where a record will be kept on file. As noted above, the University uses these records

to track repeat offenders.

In order to protect academic integrity, the following policies will be followed:

(a) A student may be given an oral examination on any assignment at any time.

(b) All electronic equipment must be turned off and placed out of sight during tests. The presence

of active electronic equipment may be considered as an attempt to engage in cheating.

(c) The provision of materials used in plagiarism or cheating will be considered as serious an

offense as the plagiarism or cheating itself.

FDNT680 Syllabus

Page 14

Any violation of this policy will be taken before the Higher Education Academic and Curriculum

Committee for appropriate punitive action.

Copyright © 2024 by Andrews University. Update the year if necessary and this should always be

at the bottom of the last page. All rights reserved. No part of these course materials may be

reproduced, stored in a retrieval system, or transmitted by any form or by any means-electronic,

mechanical, photocopying, recording, or otherwise except as may be expressly permitted by the

applicable copyright statutes or in writing by Andrews University.

FDNT680 Syllabus

Page 15

Appendix 1

15 POINTS TITLE OR TOPIC

Perfect Title with EDP: 15

points

Title with 2 of the required

contents: 10 points

Title with the one required

content: 5 points

FDNT680 Syllabus

Page 16

Appendix 2

30 POINTS ANNOTADATED BIBLIOGRAPHY RUBRIC

Illegible or inaccurate annotations score a 0

Rubric

Categories:

30 points

Thorough &

Insightful: 27

points

Acceptable &

Literal: 21 points

Attempted &

Gaps: 15 points

Partial &

Incomplete: 9

points

Confused &

Inaccurate: 3

points

Number of

Annotations:

10 points

Ample margin

Notes: 9 points

Sufficient margin

notes: 7 points

Some margin

notes: 5 points

Few margin notes:

3 points

Very few

margin notes; 1

point

Quality of

Annotations:

10 points

Insightful margin

notes with many

connections made

beyond the text;

outstanding effort:

9 points

Literal margin

notes show

understanding of

the text; sufficient

effort: 7 points

Some margin

notes show

confusion: some

effort: 5 points

Many margin

notes show

confusion: little

effort: 3 points

Most margin

notes show

confusion or

inaccurate;

very little

effort: 1 point

Quality of

Writing: 10

points

Very neat writing;

very easy to read:

9 points

Neat writing

readable: 7 points

Attempted to

write neatly, some

areas require

effort to read: 5

points

Struggled to write

neatly; many areas

require effort to

read: 3 points

Really

Struggled to

write neatly;

most areas are

difficult to

read: 1 point

30 27 21 15 9 3

FDNT680 Syllabus

Page 17

Appendix 3

Systematic and Review Literature: 100 points

Criterion Excellent: (100) Good: (90) Satisfactory: (80) Needs Improvement

(70)

Unsatisfactory:

(50)

Research

Quality and

Relevance

Sources are scholarly,

credible, and highly

relevant to the topic; a

variety of perspectives

are well-integrated.

Sources are credible

and mostly relevant;

minor gaps in

coverage, but overall

sufficient.

Sources are somewhat

relevant but lack

depth or variety;

several sources lack

credibility.

Sources are minimally

relevant or mostly not

credible; coverage of

topic is lacking.

Sources are

irrelevant, outdated,

or lacking

credibility; topic is

insufficiently

addressed.

Depth of

Analysis and

Synthesis

Demonstrates in-depth

analysis and synthesis of

research; integrates

multiple perspectives

seamlessly.

Shows good synthesis

and some analysis;

integrates different

perspectives, but some

may lack depth.

Basic synthesis with

limited analysis;

perspectives are

presented without

strong integration.

Minimal synthesis or

analysis; perspectives are

mostly summarized

rather than analyzed.

Lacks synthesis and

analysis;

perspectives are

presented without

critical insight.

Clarity and

Organization

Literature review is

well-organized, flows

logically, and uses clear,

professional language;

follows assignment

format.

Organization is

generally clear and

logical; minor issues

with flow or clarity;

mostly follows

assignment format.

Organization is

adequate but lacks

cohesion in some

areas; language and

structure require

improvement.

Organization is unclear or

illogical; language and

structure are inconsistent

or difficult to follow.

Disorganized and

difficult to

understand; lacks

adherence to

assignment format.

Referencing

and Citation

References and citations

are accurate and

complete, following the

required citation style

consistently.

References and

citations are mostly

accurate, with few

minor errors; generally

follows the required

style.

Several references or

citations contain

errors; style is

inconsistent in places.

Significant errors in

referencing and citation;

does not consistently

follow required style.

Referencing is

inaccurate or

missing; lacks

adherence to

required citation

style.

Argument

Structure

and

Coherence

Presents a clear,

coherent argument

throughout; supports

claims with relevant

evidence and logical

progression.

Presents a generally

coherent argument;

supports claims well

but may lack depth in

some areas.

Argument is mostly

clear, though parts

lack coherence or

sufficient support.

Argument is unclear or

inconsistent; lacks logical

progression and sufficient

supporting evidence.

No clear argument

is presented; lacks

coherence and

necessary support

for claims.

FDNT680 Syllabus

Page 18

Appendix 4

Evaluation of Oral Presentation

Criteria Excellent Very Good Good Poor

Content

Opening

Opening

captivates the

audience with

interest and/or

intrigue. 10 points

Interesting

opening; engages

audience. 8 points

Opening is

minimally

engaging. 6 points

Opening is not

engaging. 4 points

Organization

Information/ideas

are presented in a

consistently

logical sequence.

Transition/conne

ctions are

eloquent. A

strong sense of

wholeness is

conveyed.

Conclusion

leaves the

audience with a

strong sense of

closure. 10

points

Important ideas

and information

are identified for

the audience.

Information/ideas

are presented in a

logical sequence

with few lapses.

Transitions and

connections are

made. Closing

effectively

summarizes the

presentation. 8

points

Irrelevant,

unnecessary

information

detracts. Big

ideas are not

specifically

identified. There

are significant

lapses in the

order of ideas.

Transitions are

inconsistent and

weak or missing.

Closing

demonstrates an

attempt to

summarize. 6

points

No clear

organization.

Ideas do not

connect with one

another. There are

no clear

transitions.

No closing is

evident. 4 points

FDNT680 Syllabus

Page 19

Presentation

Speech

Commands

audience politely

using eye contact,

making sure the

audience is ready.

Can be heard by

all members of

the audience

without

assistance. Uses

visual aid as a

guide or outline

for speaking.

Consistently

maintains eye

contact. 20 points

Makes sure the

audience is ready

before starting.

May need

reminders from the

audience to speak

up; generally,

consistently

maintains eye

contact and

minimizes reliance

on notes. 15 points

Makes occasional

eye contact, makes

few attempts to

command the

audience; may

start speaking

before an audience

is ready. Needs

reminders from

the audience to

speak up. Mostly

reads from notes.

10 points

The audience

hears with great

difficulty. Reads

notes and seldom

establishes eye

contact. 5 points

FDNT680 Syllabus

Page 20

Visual Aid

Visual aid

readable and

attractive from all

parts of the room.

Graphic is clear

and professional

looking,

enhancing the

message. 10

points.

Visual aid

readable from all

parts of the room.

Graphic is neat.

Appropriate

subject chosen to

depict message. 8

points

Visual aid is not

completely

accessible to all

audience

members.

Graphic may be

messy. Visual may

not be most

appropriate to

support

presentation. 6

points

Visual aid is

indecipherable.

The graphic

detracts from

the message.

Messy or

inappropriate

visual. 4 points

Content

The content of the

presentation

reflects extensive

research and is

based on strong

scientific

evidence. 40

points

The content of the

presentation

reflects some

supportive

research. 30 points

The content of the

presentation

reflects limited

research to

support it. 20

points

The content of the

presentation

reflects limited

research. 10 points

Time Frame

The presentation

falls within the

required time

frame.

The presentation

falls within the

required time

frame.

Presentation is

less than the

minimum time.

Presentation is

more than the

maximum time.

Total Points /100 points

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