Changes in Inhibition and Valuation After Eating

Mount Sinai Health System

Status: Enrolling

Conditions: Bulimia Nervosa

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05995496

1R01MH132786 (U.S. NIH Grant/Contract)

STUDY-22-01587

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Participants with Bulimia Nervosa

Experimental group

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.

Treatment:

Other: Magnetic Resonance Imaging

Other: Fasting state

Other: Fed state

Participants without Bulimia Nervosa

Active Comparator group

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.

Treatment:

Other: Magnetic Resonance Imaging

Other: Fasting state

Other: Fed state