Changes in Inhibition and Valuation After Eating

NCT ID: NCT05995496

Last Updated: 2026-02-17

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

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-12

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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The overarching goal of this project is to test a neurocomputational model of BN that incorporates learning and decision-making components of control. The study combines functional magnetic resonance imaging (fMRI), computational modeling, and real-time mobile assessments to examine the influences of acute fasting and eating on brain function and associated control-related updating and effort-valuation processes in BN. More specifically, the study has the following main objectives: 1) To determine the influence of eating on control-related prediction updating in BN.; 2) To determine the influence of eating on control-related cognitive effort valuation in BN; 3) To use state-specific neural activation to predict BN symptoms.

Conditions

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Bulimia Nervosa

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Two participant groups (one with and one without bulimia nervosa) will be scanned using MRI after they have fasted and after they have consumed a standardized meal. The order of these two scans will be counterbalanced across groups.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Fasting state

Intervention Type OTHER

16 hours of fasting

Fed state

Intervention Type OTHER

Fed a standardized meal

Magnetic Resonance Imaging

Intervention Type OTHER

Neuroimaging with computational modeling

Participants without 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.

Group Type ACTIVE_COMPARATOR

Fasting state

Intervention Type OTHER

16 hours of fasting

Fed state

Intervention Type OTHER

Fed a standardized meal

Magnetic Resonance Imaging

Intervention Type OTHER

Neuroimaging with computational modeling

Interventions

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Fasting state

16 hours of fasting

Intervention Type OTHER

Fed state

Fed a standardized meal

Intervention Type OTHER

Magnetic Resonance Imaging

Neuroimaging with computational modeling

Intervention Type OTHER

Other Intervention Names

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MRI

Eligibility Criteria

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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


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Laura Berner

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laura A Berner, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Mount Sinai Icahn School of Medicine

Locations

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

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Riley Macks, B.A.

Role: CONTACT

(212) 824-9545

Riley Macks

Role: CONTACT

(212) 824-9545

Facility Contacts

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Jiulin Dai, B.S.

Role: primary

212-824-9561

Riley Macks

Role: backup

(212) 824-9545

Other Identifiers

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1R01MH132786

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY-22-01587

Identifier Type: -

Identifier Source: org_study_id

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