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Study of Food Aversion in Patients With Anorexia Nervosa

Primary Purpose

Anorexia Nervosa

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
A breakfast sandwich
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Anorexia Nervosa focused on measuring psychopathology, treatment, epoxide hydrolases, polyunsaturated fatty acids, eicosanoids

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts 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.

Sites / Locations

  • UC San Diego Altman Clinical and Translational Research InstituteRecruiting
  • Program for Eating Disorders, Toronto General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Anorexia nervosa I

Anorexia nervosa II

Controls

Arm Description

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

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

Healthy control women

Outcomes

Primary Outcome Measures

Change of metabolism biomarker
Percentage change of metabolism marker
Food aversion/anxiety
Percentage change of food aversion/anxiety score

Secondary Outcome Measures

Weight
Change in body weight, kg
Psychopathology
Percentage change in eating disorder psychopathology score

Full Information

First Posted
March 3, 2017
Last Updated
August 3, 2022
Sponsor
University of California, San Diego
Collaborators
University of Toronto, University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT03100656
Brief Title
Study of Food Aversion in Patients With Anorexia Nervosa
Official Title
Solving EPHX2 and Polyunsaturated Fatty Acid Interactions in Anorexia Nervosa
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 10, 2016 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
University of Toronto, University of California, Davis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
psychopathology, treatment, epoxide hydrolases, polyunsaturated fatty acids, eicosanoids

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anorexia nervosa I
Arm Type
Other
Arm Description
Anorexia nervosa with BMI <=17.5 kg/m² or BMI >17.5 kg/m² with regular binge-purge episodes
Arm Title
Anorexia nervosa II
Arm Type
Other
Arm Description
Anorexia nervosa with BMI > 18.5 kg/m² for at least 12 months.
Arm Title
Controls
Arm Type
Other
Arm Description
Healthy control women
Intervention Type
Other
Intervention Name(s)
A breakfast sandwich
Intervention Description
A meat-based breakfast sandwich
Primary Outcome Measure Information:
Title
Change of metabolism biomarker
Description
Percentage change of metabolism marker
Time Frame
2 hours
Title
Food aversion/anxiety
Description
Percentage change of food aversion/anxiety score
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Weight
Description
Change in body weight, kg
Time Frame
6 and 12 months
Title
Psychopathology
Description
Percentage change in eating disorder psychopathology score
Time Frame
6 and 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pei-an (Betty) Shih, MPM, PhD
Phone
(858) 534-0828
Email
eatingdisorderresearch@ucsd.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Nhien Nguyen, MS
Email
n7nguyen@ucsd.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pei-an (Betty) Shih, MPM, PhD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC San Diego Altman Clinical and Translational Research Institute
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
P. Betty Shih, MPM, PhD
Phone
858-534-0828
Email
eatingdisorderresearch@ucsd.edu
First Name & Middle Initial & Last Name & Degree
Pei-an Betty Shih, MPM, PhD
Facility Name
Program for Eating Disorders, Toronto General Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28232135
Citation
Shih PB. Integrating multi-omics biomarkers and postprandial metabolism to develop personalized treatment for anorexia nervosa. Prostaglandins Other Lipid Mediat. 2017 Sep;132:69-76. doi: 10.1016/j.prostaglandins.2017.02.002. Epub 2017 Feb 21.
Results Reference
background
PubMed Identifier
26944296
Citation
Shih PA, Woodside DB. Contemporary views on the genetics of anorexia nervosa. Eur Neuropsychopharmacol. 2016 Apr;26(4):663-73. doi: 10.1016/j.euroneuro.2016.02.008. Epub 2016 Feb 20.
Results Reference
background
PubMed Identifier
25824304
Citation
Shih PB, Yang J, Morisseau C, German JB, Zeeland AA, Armando AM, Quehenberger O, Bergen AW, Magistretti P, Berrettini W, Halmi KA, Schork N, Hammock BD, Kaye W. Dysregulation of soluble epoxide hydrolase and lipidomic profiles in anorexia nervosa. Mol Psychiatry. 2016 Apr;21(4):537-46. doi: 10.1038/mp.2015.26. Epub 2015 Mar 31.
Results Reference
background
PubMed Identifier
31540208
Citation
Nguyen N, Dow M, Woodside B, German JB, Quehenberger O, Shih PB. Food-Intake Normalization of Dysregulated Fatty Acids in Women with Anorexia Nervosa. Nutrients. 2019 Sep 13;11(9):2208. doi: 10.3390/nu11092208.
Results Reference
result
Links:
URL
https://g3garcia.wixsite.com/eatdisordersresearch
Description
Food Aversion Study For Anorexia Nervosa at University of California, San Diego

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Study of Food Aversion in Patients With Anorexia Nervosa

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