Study of Food Aversion in Patients With Anorexia Nervosa

November 9, 2023 updated by: Pei-an (Betty) Shih, University of California, San Diego

Solving EPHX2 and Polyunsaturated Fatty Acid Interactions in 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Recruiting
        • Program for Eating Disorders, Toronto General Hospital
        • Contact:
        • Contact:
          • D. Blake Woodside, MD FRCPC
          • Phone Number: 416-340-4445
          • Email: pbshih@ucsd.edu
        • Principal Investigator:
          • D. Blake Woodside, MD FRCPC
        • Principal Investigator:
          • Pei-an (Betty) Shih, PhD
  • United States
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • UC San Diego Altman Clinical and Translational Research Institute
        • Contact:
        • Principal Investigator:
          • Pei-an Betty Shih, MPM, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

University of California, Davis
University of Toronto

Investigators

  • Principal Investigator: Pei-an (Betty) Shih, MPM, PhD, University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2016

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 3, 2017

First Submitted That Met QC Criteria

March 28, 2017

First Posted (Actual)

April 4, 2017

Study Record Updates

Last Update Posted (Estimated)

November 13, 2023

Last Update Submitted That Met QC Criteria

November 9, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH106781 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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