Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT03100656

Conditions

Anorexia Nervosa

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

A breakfast sandwich

Study Details

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.

Conditions

Anorexia Nervosa

Study ID

NCT03100656

Start date

Nov 10, 2016

Status verified date

Mar, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Accepted

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 Design

Enrollment

300 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: Anorexia nervosa I

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

other: Anorexia nervosa II

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

other: Controls

Healthy control women

Interventions

A breakfast sandwich

A meat-based breakfast sandwich

Primary outcome measure

  • Change of metabolism biomarker [ Time Frame: 2 hours ]
  • Food aversion/anxiety [ Time Frame: 2 hours ]

Central Contacts and Locations

Central contacts

Pei-an (Betty) Shih, MPM, PhD

(858) 534-0828eatingdisorderresearch@ucsd.edu

Nhien Nguyen, MS

n7nguyen@ucsd.edu

Locations

UC San Diego Altman Clinical and Translational Research Institute

Recruiting

La Jolla, California, United States, 92037

Contacts

P. Betty Shih, MPM, PhD

858-534-0828eatingdisorderresearch@ucsd.edu

Principal Investigator:

Pei-an Betty Shih, MPM, PhD

Program for Eating Disorders, Toronto General Hospital

Recruiting

Toronto, Ontario, Canada

Contacts

D. Blake Woodside

416-340-4445pbshih@ucsd.edu

D. Blake Woodside, MD FRCPC

416-340-4445pbshih@ucsd.edu

Principal Investigator:

D. Blake Woodside, MD FRCPC

More Information

Sponsor

University of California, San Diego

Last update posted

Mar 31, 2026

Last verified

Mar, 2026

Keywords

  • psychopathology
  • treatment
  • epoxide hydrolases
  • polyunsaturated fatty acids
  • eicosanoids

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-03-31.