Self-Control in Bulimia Nervosa

NCT ID: NCT04409457

Last Updated: 2026-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-18
• Study Completion Date: 2024-11-05

Brief Summary

This study examines the influence of acute fasting and eating on self-control in adult females with and without bulimia nervosa (BN). Specifically, the study team is investigating whether differences in behavior and brain activation in response to computer tasks after fasting and after eating a meal could help to explain the symptoms of bulimia nervosa. Data will be collected using questionnaires and a technology called magnetic resonance imaging (MRI).

Detailed Description

Treatment-resistant binge eating and purging may be perpetuated by self-control deficits linked to reduced activation in frontostriatal circuits. To date, however, neurocognitive studies of BN have not assessed the dynamic computational processes underlying inhibition or considered the fact that individuals with BN oscillate between two extremes-under-controlled and over-controlled intake. The proposed study combines neuroimaging with computational modeling to investigate the influences of acute fasting and eating (i.e., metabolic states) on how the brains of women with bulimia nervosa (BN) adaptively prepare for and exert inhibitory control. More specifically, the study has the following main objectives: 1) To determine whether eating and fasting affect adaptive inhibitory control and related frontostriatal activation abnormally in BN; 2) To identify associations of BN severity with state-specific frontostriatal activation and behavior.

Conditions

Bulimia Nervosa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: OTHER

fasting state

Intervention Type: OTHER

16 hours of fasting

fed state

Intervention Type: OTHER

fed a standardized meal

magnetic resonance imaging

Intervention Type: OTHER

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.

Group Type: OTHER

fasting state

Intervention Type: OTHER

16 hours of fasting

fed state

Intervention Type: OTHER

fed a standardized meal

magnetic resonance imaging

Intervention Type: OTHER

neuroimaging with computational modeling

Interventions

fasting state

16 hours of fasting

Intervention Type: OTHER

fed state

fed a standardized meal

Intervention Type: OTHER

magnetic resonance imaging

neuroimaging with computational modeling

Intervention Type: OTHER

Other Intervention Names

MRI

Eligibility Criteria

Inclusion Criteria

• Female
• Aged 18 to 35 years
• Currently between 85 and 130% of the expected weight for height
• Right-handed
• English-speaking

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Laura Berner

Associate Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laura A Berner, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry, Icahn School of Medicine at Mount Sinai

Locations

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

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

K23MH118418

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GCO 19-1047

Identifier Type: -

Identifier Source: org_study_id