Study of Food Aversion in Patients With Anorexia Nervosa

NCT ID: NCT03100656

Last Updated: 2023-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-10

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Anorexia Nervosa

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Anorexia nervosa I

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

Group Type OTHER

A breakfast sandwich

Intervention Type OTHER

A meat-based breakfast sandwich

Anorexia nervosa II

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

Group Type OTHER

A breakfast sandwich

Intervention Type OTHER

A meat-based breakfast sandwich

Controls

Healthy control women

Group Type OTHER

A breakfast sandwich

Intervention Type OTHER

A meat-based breakfast sandwich

Interventions

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A breakfast sandwich

A meat-based breakfast sandwich

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Toronto

OTHER

Sponsor Role collaborator

University of California, Davis

OTHER

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Pei-an (Betty) Shih

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pei-an (Betty) Shih, MPM, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

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UC San Diego Altman Clinical and Translational Research Institute

La Jolla, California, United States

Site Status RECRUITING

Program for Eating Disorders, Toronto General Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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United States Canada

Central Contacts

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Pei-an (Betty) Shih, MPM, PhD

Role: CONTACT

(858) 534-0828

Nhien Nguyen, MS

Role: CONTACT

Facility Contacts

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P. Betty Shih, MPM, PhD

Role: primary

858-534-0828

D. Blake Woodside

Role: primary

416-340-4445

D. Blake Woodside, MD FRCPC

Role: backup

416-340-4445

References

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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.

Reference Type BACKGROUND
PMID: 28232135 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26944296 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25824304 (View on PubMed)

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.

Reference Type RESULT
PMID: 31540208 (View on PubMed)

Related Links

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https://g3garcia.wixsite.com/eatdisordersresearch

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

Other Identifiers

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R01MH106781

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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