- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04409457
Self-Control in Bulimia Nervosa
The Influences of Eating and Fasting on Inhibitory Control in Bulimia Nervosa: A Computational Neuroimaging Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10029
- Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Female
- Aged 18 to 35 years
- Currently between 85 and 130% of the expected weight for height
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: 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. |
16 hours of fasting
fed a standardized meal
neuroimaging with computational modeling
Other Names:
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Other: 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. |
16 hours of fasting
fed a standardized meal
neuroimaging with computational modeling
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brain Activation Associated With P(Stop)
Time Frame: after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart)
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Frontostriatal activation modulated by the predicted need for inhibition (P(stop) (i.e., parametric modulation by p(Stop)), measured as the mean BOLD signal across voxels within the region of interest (ROI).
Positive values indicate that neural activation increases as the predicted probability of needing to stop increases (i.e., stronger responses when stopping is predicted to be more likely), whereas negative values indicate that activation decreases as the predicted probability of needing to stop increases (i.e., greater activation when stopping is predicted to be less likely).
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after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart)
|
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Brain Activation Associated With Prediction Errors (Unsigned)
Time Frame: after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart)
|
Frontostriatal activation modulated by unsigned inhibitory control prediction errors (i.e., parametric modulation by absolute prediction error magnitude), measured as the mean BOLD signal across voxels within the region of interest (ROI).
Positive values indicate that neural activation increases with the magnitude of unsigned prediction errors (i.e., stronger responses to more surprising outcomes), whereas negative values indicate that activation decreases as unsigned prediction errors increase (i.e., relative deactivation for more surprising outcomes).
|
after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart)
|
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Brain Activation Associated With Prediction Errors (Signed)
Time Frame: after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart)
|
Frontostriatal activation modulated by signed inhibitory control prediction errors (i.e., parametric modulation by prediction error magnitude), measured as the mean BOLD signal across voxels within the region of interest (ROI).
Positive values indicate that neural activation increases as signed prediction errors become more positive (i.e., stronger responses to the surprising need for control), whereas negative values indicate that activation decreases as signed prediction errors become more positive (i.e., stronger responses to the surprising lack of need for control).
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after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart)
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Brain Activation Associated With Successful Inhibition
Time Frame: after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart)
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Frontostriatal activation associated with successful inhibition , measured as the mean BOLD signal across voxels within the region of interest (ROI) for the contrast of Successful Stop vs. Go trials.
Positive values indicate activation associated with successful inhibition.
|
after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stop Signal Reaction Time (SSRT)
Time Frame: after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart)
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Behavioral performance on the stop signal task, as measured by stop signal reaction time calculated as mean go reaction time minus the stop-signal delay at 50% successful inhibition (SSD₅₀).
Higher SSRT means longer latency before failed inhibition.
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after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart)
|
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Stop Signal Task Inhibition
Time Frame: after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart)
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Percent correct responses to stop trials on the Stop Signal Task measured by percent of stop trials on which participant successfully withheld a response (vs.
failed to withhold response).
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after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Laura A Berner, PhD, Department of Psychiatry, Icahn School of Medicine at Mount Sinai
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Hyperphagia
- Signs and Symptoms, Digestive
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Feeding Behavior
- Bulimia
- Feeding and Eating Disorders
- Bulimia Nervosa
- Fasting
- Investigative Techniques
- Chemistry Techniques, Analytical
- Spectrum Analysis
- Magnetic Resonance Spectroscopy
Other Study ID Numbers
- GCO 19-1047
- K23MH118418 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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