Self-Control in Bulimia Nervosa

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

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).

Study Overview

• Status: Recruiting
• Conditions: Bulimia Nervosa
• Intervention / Treatment: Other: fasting state; Other: fed state; Other: magnetic resonance imaging

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maia Chester, BA; Phone Number: 212-659-8799; Email: maia.chester@mssm.edu
• Study Contact Backup: Name: Laura A Berner, PhD; Phone Number: 212-659-8799; Email: laura.berner@mssm.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai
      • Principal Investigator: Laura A Berner, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

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: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: fasting state; 16 hours of fasting; Other: fed state; fed a standardized meal; Other: magnetic resonance imaging; neuroimaging with computational modeling; Other Names: MRI
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.	Other: fasting state; 16 hours of fasting; Other: fed state; fed a standardized meal; Other: magnetic resonance imaging; neuroimaging with computational modeling; Other Names: MRI

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stop Signal Reaction Time (SSRT) at fasting state	Behavioral performance on the stop signal task, as measured by stop signal reaction time	at 16 hours after fast
Stop Signal Reaction Time (SSRT) at fed state	Behavioral performance on the stop signal task, as measured by stop signal reaction time	at 30 minutes after a standardized meal
Stop Signal Task Performance at fasting state	Percent correct responses to stop trial on Stop Signal Task Performance	at 16 hours after fast
Stop Signal Task Performance at fed state	Percent correct responses to stop trial on Stop Signal Task Performance	at 30 minutes after a standardized meal
Frequency of Eating Disorder Symptom Episodes	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.	Baseline (At study screening)

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Laura A Berner, PhD, Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2020
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: May 18, 2020
• First Submitted That Met QC Criteria: May 26, 2020
• First Posted (Actual): June 1, 2020

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: control; fasting; binge eating; eating disorder; bulimia nervosa; purging
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Hyperphagia; Bulimia; Bulimia Nervosa
• 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)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 24 months following peer-reviewed article publication
• IPD Sharing Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No