Study Results
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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RECRUITING
NA
150 participants
INTERVENTIONAL
2023-12-12
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
SINGLE
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.
Fasting state
16 hours of fasting
Fed state
Fed a standardized meal
Magnetic Resonance Imaging
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.
Fasting state
16 hours of fasting
Fed state
Fed a standardized meal
Magnetic Resonance Imaging
Neuroimaging with computational modeling
Interventions
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Fasting state
16 hours of fasting
Fed state
Fed a standardized meal
Magnetic Resonance Imaging
Neuroimaging with computational modeling
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
45 Years
FEMALE
Yes
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Laura Berner
Assistant Professor
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY-22-01587
Identifier Type: -
Identifier Source: org_study_id
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