Self-Control in Bulimia Nervosa

Overview

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).

Full Title of Study: “The Influences of Eating and Fasting on Inhibitory Control in Bulimia Nervosa: A Computational Neuroimaging Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Other
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: July 31, 2024

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.

Interventions

  • Other: fasting state
    • 16 hours of fasting
  • Other: fed state
    • fed a standardized meal
  • Other: magnetic resonance imaging
    • neuroimaging with computational modeling

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • P(stop) at fasting state
    • Time Frame: at 16 hours after fast
    • Frontostriatal activation associated with the predicted likelihood that upcoming inhibition is needed (P(stop))
  • Prediction errors at fasting state
    • Time Frame: at 16 hours after fast
    • Frontostriatal activation associated with: inhibitory control prediction errors (signed and unsigned)
  • Successful inhibition at fasting state
    • Time Frame: at 16 hours after fast
    • Frontostriatal activation associated with successful inhibition
  • P(stop) at fed state
    • Time Frame: at 30 minutes after a standardized meal
    • Frontostriatal activation associated with the predicted likelihood that upcoming inhibition is needed (P(stop))
  • Prediction errors at fed state
    • Time Frame: at 30 minutes after a standardized meal
    • Frontostriatal activation associated with inhibitory control prediction errors (signed and unsigned)
  • Successful inhibition at fed state
    • Time Frame: at 30 minutes after a standardized meal
    • Frontostriatal activation associated with successful inhibition

Secondary Measures

  • Stop Signal Reaction Time (SSRT) at fasting state
    • Time Frame: at 16 hours after fast
    • Behavioral performance on the stop signal task, as measured by stop signal reaction time
  • Stop Signal Reaction Time (SSRT) at fed state
    • Time Frame: at 30 minutes after a standardized meal
    • Behavioral performance on the stop signal task, as measured by stop signal reaction time
  • Stop Signal Task Performance at fasting state
    • Time Frame: at 16 hours after fast
    • Percent correct responses to stop trial on Stop Signal Task Performance
  • Stop Signal Task Performance at fed state
    • Time Frame: at 30 minutes after a standardized meal
    • Percent correct responses to stop trial on Stop Signal Task Performance
  • Frequency of Eating Disorder Symptom Episodes
    • Time Frame: Baseline (At study screening)
    • The frequency of binge eating episodes, self-induced vomiting episodes, and fasting episodes as assessed by the Eating Disorder Examination (EDE). Frequency of episodes assessed with no minimum or maximum limit.

Participating in This Clinical Trial

Inclusion Criteria

  • Female
  • Aged 18 to 35 years
  • Currently between 85 and 120% 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

Gender Eligibility: Female

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: 18 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Icahn School of Medicine at Mount Sinai
  • Collaborator
    • National Institute of Mental Health (NIMH)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Laura Berner, Assistant Professor of Psychiatry – Icahn School of Medicine at Mount Sinai
  • Overall Official(s)
    • Laura A Berner, PhD, Principal Investigator, Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai
  • Overall Contact(s)
    • Thalia Viranda, BA, 212-659-8799, thalia.viranda@mssm.edu

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