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Changes in Inhibition and Valuation After Eating

Primary Purpose

Bulimia Nervosa

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fasting state
Fed state
Magnetic Resonance Imaging
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Bulimia Nervosa

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Participants with Bulimia Nervosa

Participants without Bulimia Nervosa

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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
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
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

Secondary Outcome Measures

Percent correct responses to stop trials and the trial-by-trial association
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
Percent correct responses to stop trials and the trial-by-trial association
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
Cognitive Effort Discounting Task Behavioral Performance
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
Cognitive Effort Discounting Task Behavioral Performance
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
Binge-eating Severity
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.
Compensatory Behavior Severity
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.
Dietary Restriction Severity
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.

Full Information

First Posted
August 1, 2023
Last Updated
October 17, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05995496
Brief Title
Changes in Inhibition and Valuation After Eating
Official Title
Dynamic Neural Computations Underlying Cognitive Control in Bulimia Nervosa
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
December 31, 2027 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bulimia Nervosa

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants with Bulimia Nervosa
Arm Type
Experimental
Arm Description
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.
Arm Title
Participants without Bulimia Nervosa
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Fasting state
Intervention Description
16 hours of fasting
Intervention Type
Other
Intervention Name(s)
Fed state
Intervention Description
Fed a standardized meal
Intervention Type
Other
Intervention Name(s)
Magnetic Resonance Imaging
Other Intervention Name(s)
MRI
Intervention Description
Neuroimaging with computational modeling
Primary Outcome Measure Information:
Title
Frontostriatal Activation Associated with Prediction Errors on the Stop Signal Task
Description
Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with inhibitory control prediction errors
Time Frame
1-2.5 hours after a 16-hour fast (fasted state)
Title
Frontostriatal Activation Associated with Prediction Errors on the Stop Signal Task
Description
Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with inhibitory control prediction errors
Time Frame
1-2.5 hours after a standardized meal (fed state)
Title
Frontostriatal Activation Encoding the Subjective Value of Cognitive Effort on the Cognitive-Effort Discounting Task
Description
Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with the subjective value of expending cognitive effort on control
Time Frame
1-2.5 hours after a 16-hour fast (fasted state)
Title
Frontostriatal Activation Encoding the Subjective Value of Cognitive Effort on the Cognitive-Effort Discounting Task
Description
Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with the subjective value of expending cognitive effort on control
Time Frame
1-2.5 hours after a standardized meal (fed state)
Secondary Outcome Measure Information:
Title
Percent correct responses to stop trials and the trial-by-trial association
Description
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
Time Frame
1-2.5 hours after a 16-hour fast (fasted state)
Title
Percent correct responses to stop trials and the trial-by-trial association
Description
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
Time Frame
1-2.5 hours after a standardized meal (fed state)
Title
Cognitive Effort Discounting Task Behavioral Performance
Description
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
Time Frame
1-2.5 hours after a 16-hour fast (fasted state)
Title
Cognitive Effort Discounting Task Behavioral Performance
Description
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
Time Frame
1-2.5 hours after a standardized meal (fed state)
Title
Binge-eating Severity
Description
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.
Time Frame
Baseline and 6-month follow-up
Title
Compensatory Behavior Severity
Description
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.
Time Frame
Baseline and 6-month follow-up
Title
Dietary Restriction Severity
Description
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.
Time Frame
Baseline and 6-month follow-up

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
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.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiulin Dai, B.S.
Phone
212-824-9561
Email
jiulin.dai@mssm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Alexa R Krugel, B.S
Email
alexa.krugel@mssm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura A Berner, Ph.D.
Organizational Affiliation
Mount Sinai Icahn School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiulin Dai, B.S.
Phone
212-824-9561
Email
jiulin.dai@mssm.edu
First Name & Middle Initial & Last Name & Degree
Alexa R Krugel, B.S.
Email
alexa.krugel@mssm.edu
First Name & Middle Initial & Last Name & Degree
Laura A Berner

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All of the individual participant data collected during the trial, after deidentification.
IPD Sharing 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
IPD Sharing 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.
IPD Sharing URL
https://nda.nih.gov/edit_collection.html?id=4723

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Changes in Inhibition and Valuation After Eating

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