Changes in Inhibition and Valuation After Eating

NCT05995496 | Recruiting

• 2 other identifiers: STUDY-22-015871R01MH132786
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Frontostriatal Activation Associated with Prediction Errors on the Stop Signal Task

  Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with inhibitory control prediction errors

  1-2.5 hours after a 16-hour fast (fasted state)

• Frontostriatal Activation Associated with Prediction Errors on the Stop Signal Task

  Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with inhibitory control prediction errors

  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

  Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with the subjective value of expending cognitive effort on control

  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

  Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with the subjective value of expending cognitive effort on control

  1-2.5 hours after a standardized meal (fed state)

Secondary Outcomes (7)

• Percent correct responses to stop trials and the trial-by-trial association

  1-2.5 hours after a 16-hour fast (fasted state)

• Percent correct responses to stop trials and the trial-by-trial association

  1-2.5 hours after a standardized meal (fed state)

• Cognitive Effort Discounting Task Behavioral Performance

  1-2.5 hours after a 16-hour fast (fasted state)

• Cognitive Effort Discounting Task Behavioral Performance

  1-2.5 hours after a standardized meal (fed state)

• Binge-eating Severity

  Baseline and 6-month follow-up

Study Arms (2)

Participants with Bulimia Nervosa

EXPERIMENTAL

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.

Other: Fasting state; Other: Fed state; Other: Magnetic Resonance Imaging

Participants without Bulimia Nervosa

ACTIVE COMPARATOR

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.

Other: Fasting state; Other: Fed state; Other: Magnetic Resonance Imaging

Interventions

Fasting state OTHER

16 hours of fasting

Participants with Bulimia Nervosa; Participants without Bulimia Nervosa

Fed state OTHER

Fed a standardized meal

Participants with Bulimia Nervosa; Participants without Bulimia Nervosa

Magnetic Resonance Imaging OTHER

Neuroimaging with computational modeling

Also known as: MRI

Participants with Bulimia Nervosa; Participants without Bulimia Nervosa

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: The prevalence of bulimia nervosa is substantially greater in women than in men. Moreover, prior research suggest that men and women show different neural response patterns during the engagement of inhibitory control, and that satiety differentially impacts the neural function of men and women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

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

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Bulimia Nervosa

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Laura A Berner, Ph.D.

  Mount Sinai Icahn School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Riley Macks, B.A.

CONTACT

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

Riley Macks

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 16, 2023
• Study Start: December 12, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Specify Other Time FrameWithin one year of the completion of the funded project period or upon acceptance of the data for publication, whichever is earlier
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose. Any purpose. Specify Other Mechanism All data will be deposited to the National Data Archive (NDA) starting 12 months after the award begins and will be deposited every 6 months thereafter following the usual NDA data submission dates. The research community will be able to find the data through this study's NDA Collection C4723. The research community will have access to the data within one year of the completion of the funded project period or upon acceptance of the data for publication, whichever is earlier. NDA will make decisions about how long to preserve the data, but that data archive has not deleted any deposited data up to now.

Locations

US (1)