Study of Food Aversion in Patients With Anorexia Nervosa

Anorexia Nervosa Clinical Trial

Official title:

Solving EPHX2 and Polyunsaturated Fatty Acid Interactions in Anorexia Nervosa

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03100656
• Other study ID #: R01MH106781
• Status: Recruiting
• Phase: N/A
• Start date: November 10, 2016
• Est. completion date: December 31, 2026

Study information

• Verified date: November 2023
• Source: University of California, San Diego
• Contact: Pei-an (Betty) Shih, MPM, PhD
• Phone: (858) 534-0828
• Email: eatingdisorderresearch[@]ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2026
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Other:
• A breakfast sandwich
A meat-based breakfast sandwich

Locations

Country	Name	City	State
Canada	Program for Eating Disorders, Toronto General Hospital	Toronto	Ontario
United States	UC San Diego Altman Clinical and Translational Research Institute	La Jolla	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Diego	University of California, Davis, University of Toronto

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of metabolism biomarker	Percentage change of metabolism marker	2 hours
Primary	Food aversion/anxiety	Percentage change of food aversion/anxiety score	2 hours
Secondary	Weight	Change in body weight, kg	6 and 12 months
Secondary	Psychopathology	Percentage change in eating disorder psychopathology score	6 and 12 months

External Links

•   Food Aversion Study For Anorexia Nervosa at University of California, San Diego