Changes in Inhibition and Valuation After Eating

Sponsor
Icahn School of Medicine at Mount Sinai (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05995496
Collaborator
National Institute of Mental Health (NIMH) (NIH)
169
1
2
53
3.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Fasting state
  • Other: Fed state
  • Other: Magnetic Resonance Imaging
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
169 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
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.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.
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Dynamic Neural Computations Underlying Cognitive Control in Bulimia Nervosa
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2027
Anticipated Study Completion Date :
Dec 31, 2027

Arms and Interventions

Arm Intervention/Treatment
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.

Other: Fasting state
16 hours of fasting

Other: Fed state
Fed a standardized meal

Other: Magnetic Resonance Imaging
Neuroimaging with computational modeling
Other Names:
  • MRI
  • Active Comparator: 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.

    Other: Fasting state
    16 hours of fasting

    Other: Fed state
    Fed a standardized meal

    Other: Magnetic Resonance Imaging
    Neuroimaging with computational modeling
    Other Names:
  • MRI
  • Outcome Measures

    Primary Outcome Measures

    1. Frontostriatal Activation Associated with Prediction Errors on the Stop Signal Task [1-2.5 hours after a 16-hour fast (fasted state)]

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

    2. Frontostriatal Activation Associated with Prediction Errors on the Stop Signal Task [1-2.5 hours after a standardized meal (fed state)]

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

    3. Frontostriatal Activation Encoding the Subjective Value of Cognitive Effort on the Cognitive-Effort Discounting Task [1-2.5 hours after a 16-hour fast (fasted state)]

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

    4. Frontostriatal Activation Encoding the Subjective Value of Cognitive Effort on the Cognitive-Effort Discounting Task [1-2.5 hours after a standardized meal (fed state)]

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

    Secondary Outcome Measures

    1. Percent correct responses to stop trials and the trial-by-trial association [1-2.5 hours after a 16-hour fast (fasted state)]

      Behavioral performance on the stop signal task, as measured by percent correct responses to stop trials and the trial-by-trial association between the predicted likelihood that upcoming inhibition is needed (P(stop)) from a Bayesian ideal observer model and accuracy

    2. Percent correct responses to stop trials and the trial-by-trial association [1-2.5 hours after a standardized meal (fed state)]

      Behavioral performance on the stop signal task, as measured by percent correct responses to stop trials and the trial-by-trial association between the predicted likelihood that upcoming inhibition is needed (P(stop)) from a Bayesian ideal observer model and accuracy

    3. Cognitive Effort Discounting Task Behavioral Performance [1-2.5 hours after a 16-hour fast (fasted state)]

      The subjective value of cognitive effort estimated for each N-back load level and cost- and benefit-modulated drift rate parameters from a drift- diffusion model applied to behavioral performance data

    4. Cognitive Effort Discounting Task Behavioral Performance [1-2.5 hours after a standardized meal (fed state)]

      The subjective value of cognitive effort estimated for each N-back load level and cost- and benefit-modulated drift rate parameters from a drift- diffusion model applied to behavioral performance data

    5. Binge-eating Severity [Baseline and 6-month follow-up]

      The frequency of binge-eating episodes as assessed by the Eating Disorder Examination (EDE) and Ecological Momentary Assessment (EMA). Binge-eating frequency has a minimum limit of 0 and no maximum limit. A higher score indicates a greater severity.

    6. Compensatory Behavior Severity [Baseline and 6-month follow-up]

      The frequency of compensatory behaviors as assessed by the EDE and EMA. This frequency has a minimum limit of 0 and no maximum limit. A higher score indicates a greater severity.

    7. Dietary Restriction Severity [Baseline and 6-month follow-up]

      The frequency of fasting episodes as assessed by the EDE avoidance of eating item (minimum limit = 0, maximum limit = 6); the severity of dietary restriction as assessed by the Eating Pathology Symptoms Inventory (EPSI) - restricting subscale (minimum limit=0; maximum limit=24), and the frequency of restrictive eating behaviors as assessed by EMA (minimum limit=0; no maximum limit). On all measures, a higher score indicates a greater severity.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai New York New York United States 10029

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Laura A Berner, Ph.D., Mount Sinai Icahn School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Laura Berner, Assistant Professor, Icahn School of Medicine at Mount Sinai
    ClinicalTrials.gov Identifier:
    NCT05995496
    Other Study ID Numbers:
    • STUDY-22-01587
    • 1R01MH132786
    First Posted:
    Aug 16, 2023
    Last Update Posted:
    Aug 16, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 16, 2023