NCT03100656

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Nov 2016Dec 2027

Study Start

First participant enrolled

November 10, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

10.6 years

First QC Date

March 3, 2017

Last Update Submit

March 28, 2026

Conditions

Anorexia Nervosa

Keywords

psychopathologytreatmentepoxide hydrolasespolyunsaturated fatty acidseicosanoids

Outcome Measures

Primary Outcomes (2)

  • Change of metabolism biomarker

    Percentage change of metabolism marker

    2 hours

  • Food aversion/anxiety

    Percentage change of food aversion/anxiety score

    2 hours

Secondary Outcomes (2)

  • Weight

    6 and 12 months

  • Psychopathology

    6 and 12 months

Study Arms (3)

Anorexia nervosa I

OTHER

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

Other: A breakfast sandwich

Anorexia nervosa II

OTHER

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

Other: A breakfast sandwich

Controls

OTHER

Healthy control women

Other: A breakfast sandwich

Interventions

A breakfast sandwichOTHER

A meat-based breakfast sandwich

Anorexia nervosa IAnorexia nervosa IIControls

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UC San Diego Altman Clinical and Translational Research Institute

La Jolla, California, 92037, United States

RECRUITING

Program for Eating Disorders, Toronto General Hospital

Toronto, Ontario, Canada

RECRUITING

Related Publications (4)

  • 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.

    PMID: 28232135BACKGROUND

  • 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.

    PMID: 26944296BACKGROUND

  • 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.

    PMID: 25824304BACKGROUND

  • 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.

    PMID: 31540208RESULT

Related Links

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

  • Pei-an (Betty) Shih, MPM, PhD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pei-an (Betty) Shih, MPM, PhD

CONTACT

(858) 534-0828eatingdisorderresearch@ucsd.edu

Nhien Nguyen, MS

CONTACT

n7nguyen@ucsd.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 3, 2017

First Posted

April 4, 2017

Study Start

November 10, 2016

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)US(1)