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NCT Number: NCT03100656

Study of Food Aversion in Patients With Anorexia Nervosa

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.

Recruiting

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Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Program for Eating Disorders, Toronto General Hospital, Toronto, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

A breakfast sandwich

Other

A meat-based breakfast sandwich

Primary outcomes

  1. Change of metabolism biomarker

    Time frame: 2 hours

    Percentage change of metabolism marker

  2. Food aversion/anxiety

    Time frame: 2 hours

    Percentage change of food aversion/anxiety score

Secondary outcomes

  1. Weight

    Time frame: 6 and 12 months

    Change in body weight, kg

  2. Psychopathology

    Time frame: 6 and 12 months

    Percentage change in eating disorder psychopathology score

Study contacts

Contact information is provided by the study sponsor or research team.

Nhien Nguyen, MS

CONTACT

[email protected]

Pei-an (Betty) Shih, MPM, PhD

CONTACT

[email protected]

(858) 534-0828

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • University of California, Davis
  • University of Toronto

Registry information

Official study title

Solving EPHX2 and Polyunsaturated Fatty Acid Interactions in Anorexia Nervosa

Important dates

Study start
2016
Primary completion
2027
Study completion
2027
First posted
Apr 4, 2017
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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