Study of Food Aversion in Patients With Anorexia Nervosa

Not Applicable

Recruiting

• Conditions: Anorexia Nervosa
• Interventions: Other: A breakfast sandwich

• Registration Number: NCT03100656
• Lead Sponsor: University of California, San Diego

Brief Summary

This study uses a meal-challenge protocol to assess if patients with anorexia nervosa show a differential metabolism in response to food in comparison to healthy controls. This study determines how heritable and biochemical factors influence food metabolism in anorexia nervosa in order to develop more effective treatment strategies.

Detailed Description

Anorexia nervosa is a brain-based disorder that often leads to serious health consequences including death. The EPHX2 gene has been identified as a susceptibility gene for anorexia nervosa. This study utilizes a multi-omics biomarker system approach to investigate how genetic factors interact with dietary factors to influence food aversion, psychopathology, and clinical outcome in patients with anorexia nervosa.

Study Timeline

• Study Start: 2016-11-10
• Study First Submitted: 2017-03-03
• Study First Submitted QC: 2017-03-28
• Study First Posted: 2017-04-04
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-09
• Last Update Posted: 2023-11-13
• Primary Completion: 2025-06-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• Ill AN subjects will meet current Diagnostic and Statistical Manual of Mental Disorders (DSM V) diagnosis of AN, body mass index (BMI) between 11 kg/m² and 17.5 kg/m², or BMI > 17.5 kg/m² with active eating disorder symptoms.
• Recovered AN must meet the following criteria at time of study entry: 1) Current or past DSM V diagnosis of AN; 2) BMI between 18.5 kg/m2 and 30 kg/m2; 3) Having maintained a BMI of >18.5 for at least one year.
• Control must be healthy adolescent or woman negative on our screen for AN, other Axis I psychiatric illnesses, and having maintained a BMI of between 18.5-30 kg/m² since the age of 18.

Exclusion Criteria

• Exclusion criteria for AN and control subjects include: Organic brain syndrome, schizophrenia and schizoaffective disorder, untreated thyroid disease, renal disease, hepatic disease, and the regular use of fish-oil containing supplements within the last three months of the study. All pregnant and lactating individuals will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anorexia nervosa II	A breakfast sandwich	Anorexia nervosa with BMI \> 18.5 kg/m² for at least 12 months.
Anorexia nervosa I	A breakfast sandwich	Anorexia nervosa with BMI \<=17.5 kg/m² or BMI \>17.5 kg/m² with regular binge-purge episodes
Controls	A breakfast sandwich	Healthy control women

Primary Outcome Measures

Name	Time	Method
Change of metabolism biomarker	2 hours	Percentage change of metabolism marker
Food aversion/anxiety	2 hours	Percentage change of food aversion/anxiety score

Secondary Outcome Measures

Name	Time	Method
Psychopathology	6 and 12 months	Percentage change in eating disorder psychopathology score
Weight	6 and 12 months	Change in body weight, kg

Trial Locations

Locations (2)

UC San Diego Altman Clinical and Translational Research Institute; 🇺🇸 La Jolla, California, United States

Program for Eating Disorders, Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada