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

Trial Summary

What is the purpose of this trial?

The proposed study tests fear, gut peptide response, and perceptions of fullness as causes of gastrointestinal distress and eating disorder maintenance.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment 'Test meal description changed' for eating disorders?

The study on food choice in eating disorders suggests that changes in meal composition, such as adjusting macronutrient intake, can influence psychological and temperamental aspects of eating disorders. This implies that altering meal descriptions could potentially impact eating behaviors and treatment outcomes. ^{1 2 3 4 5}

How does this treatment for eating disorders differ from other treatments?

This treatment is unique because it focuses on understanding the physiological and psychological mechanisms in eating disorders, potentially involving stress response and autonomic nervous system (ANS) dysregulation, which are not typically addressed in standard treatments. It uses novel neuroimaging techniques and wearable devices to study these mechanisms, offering a more comprehensive approach to understanding and treating eating disorders. ^{3 6 7 8 9}

Research Team

Katherine J Forney, PhD

Principal Investigator

Ohio University

Eligibility Criteria

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 am between 18 and 40 years old.

Exclusion Criteria

I have a condition that affects my appetite or weight.

Allergy to dairy, strawberry, or honey

Recent pregnancy or current breastfeeding

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Personalized networks of eating disorder symptoms predicting eating disorder outcomes and remission. [2021]

2. England 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Food choice in disorders of eating behavior: correlations with the psychopathological aspects of the diseases. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Micro- and macroanalyses of patterns within a meal in anorexia and bulimia nervosa. [2007]

5. United States pubmed.ncbi.nlm.nih.gov

Sex differences in refeeding among hospitalized adolescents and young adults with eating disorders. [2023]

6. Switzerland 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. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Direct experience while eating: Laboratory outcomes among individuals with eating disorders versus healthy controls. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

The potential of calibrated fMRI in the understanding of stress in eating disorders. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Toward Quantifying the Psychopathology of Eating Disorders From the Autonomic Nervous System Perspective: A Methodological Approach. [2023]