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Study of Food Aversion in Patients With Anorexia Nervosa

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ClinicalTrials.gov Identifier: NCT03100656
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : February 1, 2021
Sponsor:
Collaborators:
University of Toronto
University of California, Davis
Information provided by (Responsible Party):
Pei-an (Betty) Shih, 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.

Condition or disease Intervention/treatment Phase
Anorexia Nervosa Other: A breakfast sandwich Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Solving EPHX2 and Polyunsaturated Fatty Acid Interactions in Anorexia Nervosa
Actual Study Start Date : November 10, 2016
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : December 31, 2022

Arm Intervention/treatment
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

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

Controls
Healthy control women
Other: A breakfast sandwich
A meat-based breakfast sandwich




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03100656


Contacts
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Contact: Eileen Lam 416-603-5800 ext 5494 Eileen.Lam@uhn.ca
Contact: Pei-an (Betty) Shih, MPM, PhD (858) 534-0828 eatingdisorderresearch@ucsd.edu

Locations
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United States, California
UC San Diego Altman Clinical and Translational Research Institute Recruiting
La Jolla, California, United States, 92037
Contact: P. Betty Shih, MPM, PhD    858-534-0828    eatingdisorderresearch@ucsd.edu   
Principal Investigator: Pei-an Betty Shih, MPM, PhD         
Canada, Ontario
Program for Eating Disorders, Toronto General Hospital Recruiting
Toronto, Ontario, Canada
Contact: Eileen Lam    416-603-5800 ext 5494    eileen.lam@uhn.ca   
Contact: D. Blake Woodside, MD FRCPC    416-340-4445    b.woodside@utoronto.ca   
Principal Investigator: D. Blake Woodside, MD FRCPC         
Principal Investigator: Pei-an (Betty) Shih, PhD         
Sponsors and Collaborators
University of California, San Diego
University of Toronto
University of California, Davis
Investigators
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Principal Investigator: Pei-an (Betty) Shih, MPM, PhD University of California, San Diego
Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Pei-an (Betty) Shih, Associate Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03100656    
Other Study ID Numbers: R01MH106781 ( U.S. NIH Grant/Contract )
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: February 1, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pei-an (Betty) Shih, University of California, San Diego:
psychopathology
treatment
epoxide hydrolases
polyunsaturated fatty acids
eicosanoids
Additional relevant MeSH terms:
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Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Feeding and Eating Disorders
Mental Disorders