Self-Control in Bulimia Nervosa

Bulimia Nervosa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04409457
• Other study ID #: GCO 19-1047
• Secondary ID: K23MH118418
• Status: Recruiting
• Phase: N/A
• Start date: September 18, 2020
• Est. completion date: July 31, 2024

Study information

• Verified date: October 2023
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Maia Chester, BA
• Phone: 212-659-8799
• Email: maia.chester[@]mssm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Bulimia
• Bulimia Nervosa

Intervention

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

Locations

Country	Name	City	State
United States	Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	P(stop) at fasting state	Frontostriatal activation associated with the predicted likelihood that upcoming inhibition is needed (P(stop))	at 16 hours after fast
Primary	Prediction errors at fasting state	Frontostriatal activation associated with: inhibitory control prediction errors (signed and unsigned)	at 16 hours after fast
Primary	Successful inhibition at fasting state	Frontostriatal activation associated with successful inhibition	at 16 hours after fast
Primary	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
Primary	Prediction errors at fed state	Frontostriatal activation associated with inhibitory control prediction errors (signed and unsigned)	at 30 minutes after a standardized meal
Primary	Successful inhibition at fed state	Frontostriatal activation associated with successful inhibition	at 30 minutes after a standardized meal
Secondary	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
Secondary	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
Secondary	Stop Signal Task Performance at fasting state	Percent correct responses to stop trial on Stop Signal Task Performance	at 16 hours after fast
Secondary	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
Secondary	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)