Study of Food Aversion in Patients With Anorexia Nervosa

Study Overview
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Brief Summary
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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
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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.

Official Title
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Solving EPHX2 and Polyunsaturated Fatty Acid Interactions in Anorexia Nervosa

Conditions
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Anorexia Nervosa

Intervention / Treatment
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* Other: A breakfast sandwich


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Anorexia nervosa I<br>Anorexia nervosa with BMI <=17.5 kg/m² or BMI >17.5 kg/m² with regular binge-purge episodes | Other: A breakfast sandwich<br>* A meat-based breakfast sandwich<br>|
| Other: Anorexia nervosa II<br>Anorexia nervosa with BMI > 18.5 kg/m² for at least 12 months. | Other: A breakfast sandwich<br>* A meat-based breakfast sandwich<br>|
| Other: Controls<br>Healthy control women | Other: A breakfast sandwich<br>* A meat-based breakfast sandwich<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of metabolism biomarker | Percentage change of metabolism marker | 2 hours | 
| Food aversion/anxiety | Percentage change of food aversion/anxiety score | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Change in body weight, kg | 6 and 12 months | 
| Psychopathology | Percentage change in eating disorder psychopathology score | 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psychopathology, treatment, epoxide hydrolases, polyunsaturated fatty acids, eicosanoids