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Self-Control in Bulimia Nervosa

Primary Purpose

Bulimia Nervosa

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
fasting state
fed state
magnetic resonance imaging
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Bulimia Nervosa focused on measuring bulimia nervosa, binge eating, purging, fasting, eating disorder, control

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Participants with Bulimia Nervosa

Participants without Bulimia Nervosa

Arm 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.

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.

Outcomes

Primary Outcome Measures

P(stop) at fasting state
Frontostriatal activation associated with the predicted likelihood that upcoming inhibition is needed (P(stop))
Prediction errors at fasting state
Frontostriatal activation associated with: inhibitory control prediction errors (signed and unsigned)
Successful inhibition at fasting state
Frontostriatal activation associated with successful inhibition
P(stop) at fed state
Frontostriatal activation associated with the predicted likelihood that upcoming inhibition is needed (P(stop))
Prediction errors at fed state
Frontostriatal activation associated with inhibitory control prediction errors (signed and unsigned)
Successful inhibition at fed state
Frontostriatal activation associated with successful inhibition

Secondary Outcome Measures

Stop Signal Reaction Time (SSRT) at fasting state
Behavioral performance on the stop signal task, as measured by stop signal reaction time
Stop Signal Reaction Time (SSRT) at fed state
Behavioral performance on the stop signal task, as measured by stop signal reaction time
Stop Signal Task Performance at fasting state
Percent correct responses to stop trial on Stop Signal Task Performance
Stop Signal Task Performance at fed state
Percent correct responses to stop trial on Stop Signal Task Performance
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.

Full Information

First Posted
May 18, 2020
Last Updated
October 17, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04409457
Brief Title
Self-Control in Bulimia Nervosa
Official Title
The Influences of Eating and Fasting on Inhibitory Control in Bulimia Nervosa: A Computational Neuroimaging Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 18, 2020 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bulimia Nervosa
Keywords
bulimia nervosa, binge eating, purging, fasting, eating disorder, control

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Two participant groups (one with and one without bulimia nervosa) will be scanned using MRI after they have fasted and after they have consumed a standardized meal. The order of these two scans will be counterbalanced across groups.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants with Bulimia Nervosa
Arm Type
Other
Arm 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.
Arm Title
Participants without Bulimia Nervosa
Arm Type
Other
Arm 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.
Intervention Type
Other
Intervention Name(s)
fasting state
Intervention Description
16 hours of fasting
Intervention Type
Other
Intervention Name(s)
fed state
Intervention Description
fed a standardized meal
Intervention Type
Other
Intervention Name(s)
magnetic resonance imaging
Other Intervention Name(s)
MRI
Intervention Description
neuroimaging with computational modeling
Primary Outcome Measure Information:
Title
P(stop) at fasting state
Description
Frontostriatal activation associated with the predicted likelihood that upcoming inhibition is needed (P(stop))
Time Frame
at 16 hours after fast
Title
Prediction errors at fasting state
Description
Frontostriatal activation associated with: inhibitory control prediction errors (signed and unsigned)
Time Frame
at 16 hours after fast
Title
Successful inhibition at fasting state
Description
Frontostriatal activation associated with successful inhibition
Time Frame
at 16 hours after fast
Title
P(stop) at fed state
Description
Frontostriatal activation associated with the predicted likelihood that upcoming inhibition is needed (P(stop))
Time Frame
at 30 minutes after a standardized meal
Title
Prediction errors at fed state
Description
Frontostriatal activation associated with inhibitory control prediction errors (signed and unsigned)
Time Frame
at 30 minutes after a standardized meal
Title
Successful inhibition at fed state
Description
Frontostriatal activation associated with successful inhibition
Time Frame
at 30 minutes after a standardized meal
Secondary Outcome Measure Information:
Title
Stop Signal Reaction Time (SSRT) at fasting state
Description
Behavioral performance on the stop signal task, as measured by stop signal reaction time
Time Frame
at 16 hours after fast
Title
Stop Signal Reaction Time (SSRT) at fed state
Description
Behavioral performance on the stop signal task, as measured by stop signal reaction time
Time Frame
at 30 minutes after a standardized meal
Title
Stop Signal Task Performance at fasting state
Description
Percent correct responses to stop trial on Stop Signal Task Performance
Time Frame
at 16 hours after fast
Title
Stop Signal Task Performance at fed state
Description
Percent correct responses to stop trial on Stop Signal Task Performance
Time Frame
at 30 minutes after a standardized meal
Title
Frequency of Eating Disorder Symptom Episodes
Description
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.
Time Frame
Baseline (At study screening)

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
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 & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maia Chester, BA
Phone
212-659-8799
Email
maia.chester@mssm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Laura A Berner, PhD
Phone
212-659-8799
Email
laura.berner@mssm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura A Berner, PhD
Organizational Affiliation
Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura A Berner, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

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Self-Control in Bulimia Nervosa

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