Clinical trial NCT04409457: 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
Overall status: COMPLETED
Phase: NA
Conditions: Bulimia Nervosa
Keywords: bulimia nervosa
binge eating
purging
fasting
eating disorder
control
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-06-01
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: P(stop) at fasting state
timeFrame: at 16 hours after fast
measure: Prediction errors at fasting state
timeFrame: at 16 hours after fast
measure: Successful inhibition at fasting state
timeFrame: at 16 hours after fast
measure: P(stop) at fed state
timeFrame: at 30 minutes after a standardized meal
measure: Prediction errors at fed state
timeFrame: at 30 minutes after a standardized meal
measure: Successful inhibition at fed state
timeFrame: at 30 minutes after a standardized meal
Secondary outcomes:
measure: Stop Signal Reaction Time (SSRT) at fasting state
timeFrame: at 16 hours after fast
measure: Stop Signal Reaction Time (SSRT) at fed state
timeFrame: at 30 minutes after a standardized meal
measure: Stop Signal Task Performance at fasting state
timeFrame: at 16 hours after fast
measure: Stop Signal Task Performance at fed state
timeFrame: at 30 minutes after a standardized meal
measure: Frequency of Eating Disorder Symptom Episodes
timeFrame: Baseline (At study screening)
Other outcomes:
Locations:
city: New York
country: United States
facility: Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai
name: Laura A Berner, PhD
role: PRINCIPAL_INVESTIGATOR
References: