Recruiting

Observational StudyChanges in Inhibition and Valuation After Eating

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT05995496

Conditions

Bulimia Nervosa

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Fasting state

Fed state

Magnetic Resonance Imaging

Study Details

Brief summary:

An impaired ability to exert control has been implicated in bulimia nervosa (BN), but this impairment may not represent a stable trait or be the most effective focus for treatment. This project aims to understand how predictions and value-based decisions about control may be abnormally influenced by eating in individuals with BN, thereby maintaining cycles of binge eating, purging, and restriction.

Conditions

Bulimia Nervosa

Study ID

NCT05995496

Start date

Dec 12, 2023

Status verified date

Feb, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

Female
Aged 18 to 45 years
Current BMI greater than or equal to 18.5kg/m2 but under 30kg/m2
Right-handed
English-speaking

Additional Inclusion Criteria for Women with Bulimia Nervosa:

Meet DSM-5 criteria for bulimia nervosa

Exclusion Criteria:

Medical instability
Ongoing medical treatment, medical condition, or psychiatric disorder that may interfere with study variables or participation
Shift work
Pregnancy, planned pregnancy, or lactation during the study period
Allergy to any of the ingredients in or unwillingness to consume the standardized meal or unwillingness to drink water during the fasting period
Any contraindication for fMRI

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Participants with Bulimia Nervosa

Participants are randomly assigned (in even numbers across the two groups) to scan order:

A. These participants are first scanned after 16 hours of fasting on one day, and are next scanned after a standardized meal on a second day.

B. These participants are first scanned after a standardized meal on one day, and are next scanned after 16 hours of fasting on a second day.

active comparator: Participants without Bulimia Nervosa

Interventions

Fasting state

16 hours of fasting

Fed state

Fed a standardized meal

Magnetic Resonance Imaging

Neuroimaging with computational modeling

Primary outcome measure

Frontostriatal Activation Associated with Prediction Errors on the Stop Signal Task [ Time Frame: 1-2.5 hours after a 16-hour fast (fasted state) ]
Frontostriatal Activation Associated with Prediction Errors on the Stop Signal Task [ Time Frame: 1-2.5 hours after a standardized meal (fed state) ]
Frontostriatal Activation Encoding the Subjective Value of Cognitive Effort on the Cognitive-Effort Discounting Task [ Time Frame: 1-2.5 hours after a 16-hour fast (fasted state) ]
Frontostriatal Activation Encoding the Subjective Value of Cognitive Effort on the Cognitive-Effort Discounting Task [ Time Frame: 1-2.5 hours after a standardized meal (fed state) ]

Central Contacts and Locations

Central contacts

Riley Macks, B.A.

(212) 824-9545 riley.macks@mssm.edu

Riley Macks

(212) 824-9545 riley.macks@mssm.edu

Locations

Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Jiulin Dai, B.S.

212-824-9561 jiulin.dai@mssm.edu

Riley Macks

(212) 824-9545 riley.macks@mssm.edu

Principal Investigator:

Laura A Berner

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-02-17.