Changes in Inhibition and Valuation After Eating
ConditionBulimia Nervosa
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorIcahn School of Medicine at Mount Sinai
About this trial
An impaired ability to exert control has been implicated in bulimia nervosa (BN), but this impairment may not represent a stable trait or be the most effective focus for treatment. This project aims to understand how predictions and value-based decisions about control may be abnormally influenced by eating in individuals with BN, thereby maintaining cycles of binge eating, purging, and restriction.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Female
Aged 18 to 45 years
Current BMI greater than or equal to 18.5kg/m2 but under 30kg/m2
Right-handed
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Fasting state
Other intervention16 hours of fasting
Fed state
Other interventionFed a standardized meal
Magnetic Resonance Imaging
Other interventionNeuroimaging with computational modeling
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Participants with Bulimia NervosaExperimental treatment 3 interventions
Group B: Participants without Bulimia NervosaActive comparator 3 interventions
Trial outcomes
Primary outcomes
1
Frontostriatal Activation Associated with Prediction Errors on the Stop Signal Task
Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with inhibitory control prediction errors
Time frame
1-2.5 hours after a 16-hour fast (fasted state)2
Frontostriatal Activation Associated with Prediction Errors on the Stop Signal Task
Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with inhibitory control prediction errors
Time frame
1-2.5 hours after a standardized meal (fed state)3
Frontostriatal Activation Encoding the Subjective Value of Cognitive Effort on the Cognitive-Effort Discounting Task
Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with the subjective value of expending cognitive effort on control
Time frame
1-2.5 hours after a 16-hour fast (fasted state)4
Frontostriatal Activation Encoding the Subjective Value of Cognitive Effort on the Cognitive-Effort Discounting Task
Blood oxygen level dependent (BOLD) signal in frontostriatal brain circuitry associated with the subjective value of expending cognitive effort on control
Time frame
1-2.5 hours after a standardized meal (fed state)Secondary outcomes
1
Percent correct responses to stop trials and the trial-by-trial association
Behavioral performance on the stop signal task, as measured by percent correct responses to stop trials and the trial-by-trial association between the predicted likelihood that upcoming inhibition is needed (P(stop)) from a Bayesian ideal observer model and accuracy
Time frame
1-2.5 hours after a 16-hour fast (fasted state)2
Percent correct responses to stop trials and the trial-by-trial association
Behavioral performance on the stop signal task, as measured by percent correct responses to stop trials and the trial-by-trial association between the predicted likelihood that upcoming inhibition is needed (P(stop)) from a Bayesian ideal observer model and accuracy
Time frame
1-2.5 hours after a standardized meal (fed state)3
Cognitive Effort Discounting Task Behavioral Performance
The subjective value of cognitive effort estimated for each N-back load level and cost- and benefit-modulated drift rate parameters from a drift- diffusion model applied to behavioral performance data
Time frame
1-2.5 hours after a 16-hour fast (fasted state)4
Cognitive Effort Discounting Task Behavioral Performance
The subjective value of cognitive effort estimated for each N-back load level and cost- and benefit-modulated drift rate parameters from a drift- diffusion model applied to behavioral performance data
Time frame
1-2.5 hours after a standardized meal (fed state)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Icahn School of Medicine at Mount Sinai
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov