Understanding Physiological and Psychological Mechanisms in Eating Disorders

Overseen By Katherine J Forney, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Ohio University

Disqualifiers: Pregnancy, Breastfeeding, Food allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

152 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the roles of fear, gut reactions, and perceptions of fullness in eating disorders and related stomach issues. Participants will consume yogurt labeled as either "high fat" or "low fat" to determine if these descriptions influence their gut feelings and perceptions. Women diagnosed with an eating disorder, who often experience nausea or stomachache after meals, and meet certain other criteria may be suitable for this study. As an unphased trial, this study provides participants with a unique opportunity to contribute to groundbreaking research that could enhance the understanding and treatment of eating disorders.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that yogurt is generally safe to eat as part of a healthy diet. Studies have found that eating yogurt can help reduce hunger and may lower the risk of certain diseases, such as type 2 diabetes. Most people can consume yogurt without issues, and it is often linked to healthy lifestyles. No major reports of negative effects from eating yogurt exist, making it a safe choice for many. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how the perception of food can impact eating disorders. Unlike traditional treatments focusing on behavior modification or medication, this trial examines whether simply changing how food is described—like labeling yogurt as "high fat" or "low fat"—can influence psychological and physiological responses in individuals with eating disorders. This approach could reveal new, non-invasive ways to manage these disorders by altering perceptions rather than altering the food itself. Understanding these mechanisms could lead to innovative strategies that complement existing therapies, offering a fresh perspective on treating eating disorders.

What evidence suggests that this trial's treatments could be effective for eating disorders?

Research has shown that altering meal descriptions can influence people's perceptions of eating. One study demonstrated that changing how a meal's fat content was described affected participants' fear and reactions to eating. This finding is crucial for understanding eating disorders, as certain foods can cause distress. In this trial, participants will encounter different descriptions of yogurt: one group will consume yogurt labeled as 'high fat' during one visit and 'low fat' during another, while the other group will follow the opposite order. Other studies have found that eating yogurt, whether high-fat or low-fat, can offer health benefits, such as lowering blood sugar levels. This indicates that both types of yogurt might be useful in studying eating behaviors. ^{3 6 7 8 9}

Who Is on the Research Team?

Katherine J Forney, PhD

Principal Investigator

Ohio University

Are You a Good Fit for This Trial?

This trial is for women aged 18-40 with a DSM-5 diagnosed eating disorder, feeling sick or having stomachaches after eating sometimes. They should have a BMI between 18.5 and 26.5 and experience significant distress or impairment from their condition. It's not for those with conditions affecting appetite/weight, recent/current pregnancy, dairy/strawberry/honey allergies, or specific blood-injection-injury phobias.

Inclusion Criteria

I am female.

Score 16 or higher on the Clinical Impairment Assessment

I sometimes feel nauseous or have a stomachache after eating.

Exclusion Criteria

I have a condition that affects my appetite or weight.

Allergy to dairy, strawberry, or honey

Recent pregnancy or current breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants consume yogurt described as 'high fat' or 'low fat' during study visits to assess physiological and psychological responses

2 weeks

2 visits (in-person)

Assessment

Physiological and psychological measures are taken, including fear, gastrointestinal distress, and peptide responses

1 day

Multiple assessments within a single day

Follow-up

Participants are monitored for any delayed responses or effects post-intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Test meal description changed

Trial Overview The study examines how changing the description of a test meal affects fear responses, gut hormone levels, and feelings of fullness in individuals with eating disorders to understand gastrointestinal distress and maintenance of these disorders.

How Is the Trial Designed?

Group I: Low Fat Yogurt - High Fat Yogurt Experimental Treatment 1 Intervention

Participants will eat yogurt described as 'low fat' at Study Visit 2 and yogurt described as 'high fat' at Study Visit 3.

Group II: High Fat Yogurt - Low Fat Yogurt Experimental Treatment 1 Intervention

Participants will eat yogurt described as 'high fat' at Study Visit 2 and yogurt described as 'low fat' at Study Visit 3.

Who Is Running the Clinical Trial?

Ohio University

Lead Sponsor

Trials

73

Recruited

17,800+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Women with anorexia nervosa showed distinct eating patterns compared to clinically normal women, including longer meal durations, slower eating rates, and more frequent pauses, indicating a different relationship with food.

Both anorectic and bulimic patients exhibited abnormal hunger and satiety ratings, with bulimics displaying confusion in their eating responses and a tendency to overeat, suggesting that these patterns could be important for evaluating treatment outcomes in eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Micro- and macroanalyses of patterns within a meal in anorexia and bulimia nervosa. Sunday, SR., Halmi, KA.[2007]

The study aims to improve treatment for eating disorders (EDs) by developing personalized models that account for individual differences in symptoms and pathology, as up to 50% of individuals do not respond to standard Enhanced Cognitive-Behavioral Therapy (CBT-E).

By collecting data from 120 participants over 30 days using a mobile app and a sensor wristband, the research will identify specific behavioral and physiological targets that predict treatment outcomes and remission, potentially leading to more effective, tailored interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized networks of eating disorder symptoms predicting eating disorder outcomes and remission. Levinson, CA., Cash, E., Welch, K., et al.[2021]

In a study of 124 female patients with various eating disorders, it was found that all patient groups had significantly lower intake of animal proteins compared to healthy controls, indicating a distinct alteration in food choices associated with these disorders.

The research also revealed that food choices in patients with eating disorders are correlated with psychological symptoms, suggesting that changes in nutrient intake may be influenced by underlying psychological and temperamental factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food choice in disorders of eating behavior: correlations with the psychopathological aspects of the diseases. Segura-García, C., De Fazio, P., Sinopoli, F., et al.[2018]

In a study of 588 adolescents and young adults with eating disorders, males were found to have higher prescribed caloric intake at discharge compared to females, indicating a need for tailored nutritional strategies for different sexes.

Males also experienced greater weight changes and longer hospital stays than females, suggesting that individualized treatment plans are essential for effectively managing eating disorders in young males.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sex differences in refeeding among hospitalized adolescents and young adults with eating disorders. Nagata, JM., Bojorquez-Ramirez, P., Nguyen, A., et al.[2023]

The Eating Disorder Diagnostic Scale (EDDS) has demonstrated strong reliability and validity in a clinical population of 59 female patients with eating disorders, making it a useful tool for diagnosing conditions like anorexia nervosa and bulimia nervosa.

A cut-off score of 16.5 on the EDDS effectively differentiates clinical patients from healthy controls, indicating its potential application in clinical settings and research related to eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Eating Disorder Diagnostic Scale: psychometric features within a clinical population and a cut-off point to differentiate clinical patients from healthy controls. Krabbenborg, MA., Danner, UN., Larsen, JK., et al.[2022]

In a study of 75 female patients with bulimia nervosa (BN) and 30 healthy controls, BN patients exhibited significantly higher levels of impulsivity, depressive symptoms, and personality traits associated with emotional instability compared to controls.

Biological markers such as lower serotonin and dopamine excretion, along with impaired cortisol suppression, were found in BN patients, indicating that these neurobiological factors may be linked to their psychopathological status and could serve as potential markers for the disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurobiological and psychopathological variables related to emotional instability: a study of their capability to discriminate patients with bulimia nervosa from healthy controls. Vaz-Leal, FJ., Rodríguez-Santos, L., García-Herráiz, MA., et al.[2015]

Individuals with eating disorders (EDs) showed significantly lower engagement in the direct experience of eating compared to healthy controls, indicating a potential area of concern in their relationship with food.

Participants with EDs also scored lower on mindfulness-related measures, suggesting that enhancing mindfulness could be beneficial in improving their eating experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Direct experience while eating: Laboratory outcomes among individuals with eating disorders versus healthy controls. Elices, M., Carmona, C., Narváez, V., et al.[2018]

Eating disorders like Anorexia Nervosa, Bulimia Nervosa, and Binge Eating Disorder are complex conditions influenced by a combination of genetic, neurobiological, and psychosocial factors, particularly stress.

Stress hormones play a significant role in appetite regulation and food reward systems, suggesting that dysfunction in the stress response may contribute to the development and maintenance of eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The potential of calibrated fMRI in the understanding of stress in eating disorders. Wierenga, CE., Lavender, JM., Hays, CC.[2020]

The study aims to investigate how the Autonomic Nervous System (ANS) responds to stress in individuals with Eating Disorders (ED) by measuring physiological signals and psychological profiles, using a novel methodology that integrates easily into clinical practice.

Currently, the research includes 37 patients with ED and 16 matched controls, utilizing wearable devices for continuous monitoring of ANS functioning during a controlled stress task and in naturalistic settings, with ethical approval for the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward Quantifying the Psychopathology of Eating Disorders From the Autonomic Nervous System Perspective: A Methodological Approach. Simões-Capela, N., Schiavone, G., De Raedt, W., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02795455

Reward Systems and Food Avoidance in Eating Disorders One core feature of Anorexia Nervosa (AN) is eating a small number of high-calorie or high-fat foods. ... Consumption of a standardized strawberry yogurt shake ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11737816/

Moderate full-fat and low-fat yoghurt consumption correlates ... Moderate consumption of full-fat and low-fat yoghurt was correlated with decreased all-cause mortality.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5682997/

Yogurt and Cardiometabolic Diseases: A Critical Review of ... In other prospective cohort studies, yogurt (total, high-fat, and low-fat) consumption was inversely associated with fasting plasma glucose (13) and had a ...

4. researchgate.net researchgate.net/publication/356113417_Validation_of_a_test_meal_paradigm_to_experimentally_manipulate_meal-related_fears_A_registered_report

Validation of a test meal paradigm to experimentally ... The current study will examine the reliability and validity of a test meal paradigm that varies perceptions of fat content to manipulate fear. Undergraduate ...

5. nutritionj.biomedcentral.com nutritionj.biomedcentral.com/articles/10.1186/1475-2891-13-97

Effects of high-protein vs. high- fat snacks on appetite control ... These data suggest that, when compared to high-fat snacks, eating less energy dense, high-protein snacks like yogurt improves appetite ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11056554/

Yogurt, in the context of a healthy diet, for the prevention ... In this work, we aimed at giving a perspective on the role of yogurt, as part of a healthy lifestyle, for the prevention and management of obesity and diabetes.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0002916523050773

Yogurt consumption and impact on health Interestingly, a study performed in healthy women showed that a 160-kcal afternoon Greek yogurt snack, containing 24 g protein, led to reduced hunger, increased ...

8. fda.gov fda.gov/media/176608/download

Petition for a Qualified Health Claim for Yogurt and ... The inverse association with type 2 diabetes was mainly associated with low-fat dairy intake, in which yogurt was included (RR = 0.69; 95% CI: ...

9. webmd.com webmd.com/vitamins/ai/ingredientmono-829/yogurt

Yogurt - Uses, Side Effects, and More Consumption of Yogurt, Low-Fat Milk, and Other Low-Fat Dairy Products Is ... lactis) strain BB-12-supplemented yogurt in healthy adults on antibiotics: a phase I ...