Study of Food Aversion in Patients With Anorexia Nervosa

University of California San Diego

Status: Enrolling

Conditions: Anorexia Nervosa

Treatments: Other: A breakfast sandwich

Study type: Interventional

Funder types: Other

Identifiers

NCT03100656

R01MH106781

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

Anorexia nervosa I

Other group

Description:

Anorexia nervosa with BMI \<=17.5 kg/m² or BMI \>17.5 kg/m² with regular binge-purge episodes

Treatment:

Other: A breakfast sandwich

Anorexia nervosa II

Other group

Description:

Anorexia nervosa with BMI \> 18.5 kg/m² for at least 12 months.

Treatment:

Other: A breakfast sandwich

Controls

Other group

Description:

Healthy control women

Treatment:

Other: A breakfast sandwich