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Self-Control in Bulimia Nervosa

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ClinicalTrials.gov Identifier: NCT04409457
Recruitment Status : Recruiting
First Posted : June 1, 2020
Last Update Posted : October 22, 2020
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Laura Berner, Icahn School of Medicine at Mount Sinai

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).

Condition or disease Intervention/treatment Phase
Bulimia Nervosa Other: fasting state Other: fed state Other: magnetic resonance imaging Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: The Influences of Eating and Fasting on Inhibitory Control in Bulimia Nervosa: A Computational Neuroimaging Study
Actual Study Start Date : September 25, 2020
Estimated Primary Completion Date : July 31, 2024
Estimated Study Completion Date : July 31, 2024

Arm Intervention/treatment
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 Name: MRI

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 Name: MRI




Primary Outcome Measures :
  1. 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))

  2. Prediction errors at fasting state [ Time Frame: at 16 hours after fast ]
    Frontostriatal activation associated with: inhibitory control prediction errors (signed and unsigned)

  3. Successful inhibition at fasting state [ Time Frame: at 16 hours after fast ]
    Frontostriatal activation associated with successful inhibition

  4. 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))

  5. 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)

  6. Successful inhibition at fed state [ Time Frame: at 30 minutes after a standardized meal ]
    Frontostriatal activation associated with successful inhibition


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   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.
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04409457


Contacts
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Contact: Thalia Viranda, BA 212-659-8799 thalia.viranda@mssm.edu
Contact: Laura A Berner, PhD 212-659-8725 laura.berner@mssm.edu

Locations
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United States, New York
Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Principal Investigator: Laura A Berner, Ph.D.         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Laura A Berner, PhD Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai
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Responsible Party: Laura Berner, Assistant Professor of Psychiatry, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT04409457    
Other Study ID Numbers: GCO 19-1047
K23MH118418 ( U.S. NIH Grant/Contract )
First Posted: June 1, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: Beginning 24 months following peer-reviewed article publication
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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laura Berner, Icahn School of Medicine at Mount Sinai:
bulimia nervosa
binge eating
purging
fasting
eating disorder
control
Additional relevant MeSH terms:
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Bulimia
Bulimia Nervosa
Hyperphagia
Signs and Symptoms, Digestive
Feeding and Eating Disorders
Mental Disorders