Bulimia NervosaNCT04409457

Self-Control in Bulimia Nervosa

A study testing fasting state, fed state and magnetic resonance imaging in people with Bulimia Nervosa, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for: Bulimia Nervosa
What is being tested?: fasting state, fed state and magnetic resonance imaging
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteUnited States
Study dates: 18 Sep 2020to 5 Nov 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 35 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Center of Excellence in Eating and Weight Disorders at the Icahn School of Medicine at Mount Sinai
New York, New York, 10029

Other trials in United States

About this study

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

Read the 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.

Conditions: Bulimia Nervosa
Being tested: fasting state, fed state, magnetic resonance imaging
Keywords: bulimia nervosa, binge eating, purging, fasting, eating disorder, control
Medical subject headings: Bulimia Nervosa, Bulimia, Fasting, Feeding and Eating Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

fasting stateOther
16 hours of fasting
fed stateOther
fed a standardized meal
magnetic resonance imagingOther
Also called MRI
neuroimaging with computational modeling

Study groups in NCT04409457
Study group	Role	What they receive
Participants with Bulimia Nervosa	Other	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. Receives: Other: fasting state; Other: fed state; Other: magnetic resonance imaging
Participants without Bulimia Nervosa	Other	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. Receives: Other: fasting state; Other: fed state; Other: magnetic resonance imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

Brain Activation Associated With P(Stop)
Frontostriatal activation modulated by the predicted need for inhibition (P(stop) (i.e., parametric modulation by p(Stop)), measured as the mean BOLD signal across voxels within the region of interest (ROI). Positive values indicate that neural activation increases as the predicted probability of needing to stop increases (i.e., stronger responses when stopping is predicted to be more likely), whereas negative values indicate that activation decreases as the predicted probability of needing to stop increases (i.e., greater activation when stopping is predicted to be less likely).
Measured: after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart)
Brain Activation Associated With Prediction Errors (Unsigned)
Frontostriatal activation modulated by unsigned inhibitory control prediction errors (i.e., parametric modulation by absolute prediction error magnitude), measured as the mean BOLD signal across voxels within the region of interest (ROI). Positive values indicate that neural activation increases with the magnitude of unsigned prediction errors (i.e., stronger responses to more surprising outcomes), whereas negative values indicate that activation decreases as unsigned prediction errors increase (i.e., relative deactivation for more surprising outcomes).
Measured: after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart)
Brain Activation Associated With Prediction Errors (Signed)
Frontostriatal activation modulated by signed inhibitory control prediction errors (i.e., parametric modulation by prediction error magnitude), measured as the mean BOLD signal across voxels within the region of interest (ROI). Positive values indicate that neural activation increases as signed prediction errors become more positive (i.e., stronger responses to the surprising need for control), whereas negative values indicate that activation decreases as signed prediction errors become more positive (i.e., stronger responses to the surprising lack of need for control).
Measured: after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart)
Brain Activation Associated With Successful Inhibition
Frontostriatal activation associated with successful inhibition , measured as the mean BOLD signal across voxels within the region of interest (ROI) for the contrast of Successful Stop vs. Go trials. Positive values indicate activation associated with successful inhibition.
Measured: after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart)

Secondary outcomes (2)

Stop Signal Reaction Time (SSRT)
Behavioral performance on the stop signal task, as measured by stop signal reaction time calculated as mean go reaction time minus the stop-signal delay at 50% successful inhibition (SSD₅₀). Higher SSRT means longer latency before failed inhibition.
Measured: after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart)
Stop Signal Task Inhibition
Percent correct responses to stop trials on the Stop Signal Task measured by percent of stop trials on which participant successfully withheld a response (vs. failed to withhold response).
Measured: after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Sep 20205 Nov 2024

First posted1 Jun 2020
Study start18 Sep 2020
Primary completion5 Nov 2024
Study completion5 Nov 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Bulimia NervosaStudies of the same condition, open and under way.
More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
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 blind
Who is masked: Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04409457
Sponsor's protocol ID: GCO 19-1047
Other IDs: K23MH118418
Status last verified: Nov 2025
First submitted: 18 May 2020
Last updated: 6 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Children s Growth and Behavior Study
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Naltrexone Neuroimaging in Teens With Eating Disorders
Eating Disorders, Binge Eating
Recruiting
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Binge Eating, Food Insecurity
Active, not recruitingObservational study
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Bulimia Nervosa

All Bulimia Nervosa trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Influences of Eating and Fasting on Inhibitory Control in Bulimia Nervosa: A Computational Neuroimaging Study
ClinicalTrials.gov ID: NCT04409457
Acronym / sponsor ID: GCO 19-1047
Conditions: Bulimia Nervosa
Keywords: bulimia nervosa, binge eating, purging, fasting, eating disorder, control
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Icahn School of Medicine at Mount SinaiUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 18 Sep 2020 (actual)
Primary completion: 5 Nov 2024 (actual)
Study completion: 5 Nov 2024 (actual)
First posted: 1 Jun 2020 (actual)
Results: Posted 14 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
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.

Arm	Type	Receives
Participants with Bulimia Nervosa	Other	Other: fasting state, Other: fed state, Other: magnetic resonance imagingParticipants 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 without Bulimia Nervosa	Other	Other: fasting state, Other: fed state, Other: magnetic resonance imagingParticipants 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.

Who may qualify

Ages: 18 to 35 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Female
Aged 18 to 35 years
Currently between 85 and 130% of the expected weight for height
Right-handed
English-speaking

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
fasting state16 hours of fasting	Other	Participants with Bulimia Nervosa, Participants without Bulimia Nervosa
fed statefed a standardized meal	Other	Participants with Bulimia Nervosa, Participants without Bulimia Nervosa
magnetic resonance imagingAlso: MRIneuroimaging with computational modeling	Other	Participants with Bulimia Nervosa, Participants without Bulimia Nervosa

Primary outcome

Brain Activation Associated With P(Stop)
Time frame: after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart)
Frontostriatal activation modulated by the predicted need for inhibition (P(stop) (i.e., parametric modulation by p(Stop)), measured as the mean BOLD signal across voxels within the region of interest (ROI). Positive values indicate that neural activation increases as the predicted probability of needing to stop increases (i.e., stronger responses when stopping is predicted to be more likely), whereas negative values indicate that activation decreases as the predicted probability of needing to stop increases (i.e., greater activation when stopping is predicted to be less likely).
Brain Activation Associated With Prediction Errors (Unsigned)
Time frame: after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart)
Frontostriatal activation modulated by unsigned inhibitory control prediction errors (i.e., parametric modulation by absolute prediction error magnitude), measured as the mean BOLD signal across voxels within the region of interest (ROI). Positive values indicate that neural activation increases with the magnitude of unsigned prediction errors (i.e., stronger responses to more surprising outcomes), whereas negative values indicate that activation decreases as unsigned prediction errors increase (i.e., relative deactivation for more surprising outcomes).
Brain Activation Associated With Prediction Errors (Signed)
Time frame: after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart)
Frontostriatal activation modulated by signed inhibitory control prediction errors (i.e., parametric modulation by prediction error magnitude), measured as the mean BOLD signal across voxels within the region of interest (ROI). Positive values indicate that neural activation increases as signed prediction errors become more positive (i.e., stronger responses to the surprising need for control), whereas negative values indicate that activation decreases as signed prediction errors become more positive (i.e., stronger responses to the surprising lack of need for control).
Brain Activation Associated With Successful Inhibition
Time frame: after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart)
Frontostriatal activation associated with successful inhibition , measured as the mean BOLD signal across voxels within the region of interest (ROI) for the contrast of Successful Stop vs. Go trials. Positive values indicate activation associated with successful inhibition.

2 secondary outcomes

Stop Signal Reaction Time (SSRT)
Time frame: after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart)
Stop Signal Task Inhibition
Time frame: after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart)

Results and safety

Results posted to the registry on 14 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Participants With Bulimia Nervosa	51	33
Healthy Control Participants Without Bulimia Nervosa	49	35
Bulimia Nervosa Fast Then Fed	0	0
Bulimia Nervosa Fed Then Fast	0	0
Healthy Control Fast Then Fed	0	0
Healthy Control Fed Then Fast	0	0

Primary outcome: Brain Activation Associated With P(Stop)

Time frame: after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart). Mean (Standard Deviation). Unit: BOLD Signal

Measure	Participants With Bulimia Nervosa (Fasted Scan) n = 28	Participants With Bulimia Nervosa (Fed Scan) n = 28	Healthy Control Participants (Fasted Scan) n = 28	Healthy Control Participants (Fed Scan) n = 28
Left DLPFC Brain Activation	0.02 (0.32)	0.11 (0.35)	0.04 (0.41)	0.05 (0.34)
Left Caudate Brain Activation	-0.16 (0.36)	-0.06 (0.35)	-0.05 (0.31)	-0.07 (0.39)
Left Putamen Brain Activation	-0.06 (0.28)	-0.01 (0.27)	0.02 (0.31)	-0.01 (0.29)
Left Dorsal ACC Activation	-0.07 (0.27)	0 (0.29)	-0.08 (0.30)	-0.06 (0.31)
Left VLPFC Brain Activation	0.01 (0.28)	0.03 (0.29)	-0.01 (0.32)	0.02 (0.28)
Right DLPFC Brain Activation	0.07 (0.36)	0.14 (0.37)	0.14 (0.36)	0.12 (0.34)
Right Caudate Brain Activation	-0.12 (0.42)	0 (0.38)	-0.02 (0.32)	-0.01 (0.45)
Right Putamen Brain Activation	-0.05 (0.31)	-0.01 (0.29)	0.02 (0.35)	-0.01 (0.30)

Population analysed: Brain imaging data were pre-processed and analyzed for each group and state. Data from 8 participants were excluded: 2 HC due to technical malfunction that caused loss of behavioral data from their 2nd MRI visit, 1 HC for incidental finding on MRI (not identified until after their 2nd scan), 2 (1 BN, 1 HC) for insufficient trials for analysis in a key condition at one or both scans, and 3 BN for excessive movement (\>20% of TRs with ≥0.5mm framewise displacement) at one or both scans.

Primary outcome: Brain Activation Associated With Prediction Errors (Unsigned)

Time frame: after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart). Mean (Standard Deviation). Unit: BOLD Signal

Measure	Participants With Bulimia Nervosa (Fasted Scan) n = 28	Participants With Bulimia Nervosa (Fed Scan) n = 28	Healthy Control Participants (Fasted Scan) n = 28	Healthy Control Participants (Fed Scan) n = 28
Left DLPFC Brain Activation	0.09 (0.29)	0.13 (0.35)	0.08 (0.40)	0.09 (0.29)
Left Caudate Brain Activation	0.07 (0.35)	0.11 (0.30)	0.06 (0.46)	0.08 (0.32)
Left Putamen Brain Activation	-0.03 (0.26)	-0.02 (0.32)	0.01 (0.35)	-0.06 (0.39)
Left Dorsal ACC Activation	-0.02 (0.32)	0.07 (0.29)	0.09 (0.41)	-0.01 (0.26)
Left VLPFC Brain Activation	0.04 (0.31)	0.11 (0.36)	0.09 (0.40)	0.04 (0.26)
Right DLPFC Brain Activation	0.33 (0.37)	0.32 (0.31)	0.38 (0.38)	0.39 (0.36)
Right Caudate Brain Activation	0.12 (0.38)	0.12 (0.29)	0.07 (0.53)	0.14 (0.32)
Right Putamen Brain Activation	0.13 (0.31)	0.08 (0.28)	0.14 (0.35)	0.07 (0.35)

Primary outcome: Brain Activation Associated With Prediction Errors (Signed)

Time frame: after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart). Mean (Standard Deviation). Unit: BOLD Signal

Measure	Participants With Bulimia Nervosa (Fasted Scan) n = 28	Participants With Bulimia Nervosa (Fed Scan) n = 28	Healthy Control Participants (Fasted Scan) n = 28	Healthy Control Participants (Fed Scan) n = 28
Left DLPFC Brain Activation	0.05 (0.29)	0.07 (0.40)	0.03 (0.40)	0.02 (0.32)
Left Caudate Brain Activation	0.16 (0.35)	0.16 (0.34)	0.06 (0.45)	0.05 (0.41)
Left Putamen Brain Activation	-0.04 (0.25)	-0.07 (0.33)	-0.07 (0.34)	-0.13 (0.41)
Left Dorsal ACC Activation	0.03 (0.36)	0.09 (0.36)	0.10 (0.43)	-0.01 (0.31)
Left VLPFC Brain Activation	0.02 (0.33)	0.10 (0.41)	0.07 (0.39)	0.03 (0.26)
Right DLPFC Brain Activation	0.25 (0.33)	0.24 (0.36)	0.28 (0.39)	0.30 (0.38)
Right Caudate Brain Activation	0.15 (0.37)	0.09 (0.36)	0.04 (0.48)	0.10 (0.40)
Right Putamen Brain Activation	0.12 (0.29)	0.06 (0.28)	0.06 (0.33)	0.02 (0.40)

Primary outcome: Brain Activation Associated With Successful Inhibition

Time frame: after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart). Mean (Standard Deviation). Unit: BOLD Signal

Measure	Participants With Bulimia Nervosa (Fasted Scan) n = 28	Participants With Bulimia Nervosa (Fed Scan) n = 28	Healthy Control Participants (Fasted Scan) n = 28	Healthy Control Participants (Fed Scan) n = 28
Left DLPFC Brain Activation	0.06 (0.27)	0.11 (0.40)	0.08 (0.36)	0.06 (0.33)
Left Caudate Brain Activation	0.18 (0.30)	0.21 (0.31)	0.12 (0.48)	0.10 (0.36)
Left Putamen Brain Activation	0.06 (0.23)	0.09 (0.33)	0.07 (0.37)	0.04 (0.39)
Left Dorsal ACC Activation	-0.04 (0.32)	0.09 (0.37)	0.06 (0.43)	-0.04 (0.28)
Left VLPFC Brain Activation	0.02 (0.32)	0.12 (0.44)	0.07 (0.38)	0.02 (0.23)
Right DLPFC Brain Activation	0.29 (0.32)	0.32 (0.38)	0.43 (0.37)	0.39 (0.38)
Right Caudate Brain Activation	0.22 (0.34)	0.16 (0.32)	0.15 (0.52)	0.19 (0.34)
Right Putamen Brain Activation	0.18 (0.28)	0.16 (0.30)	0.18 (0.36)	0.15 (0.39)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: At baseline clinical interviews, the 16-hour fasting period before scan visits, and at the two scan visits (up to 3 weeks on average). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Participants With Bulimia Nervosa	0 of 32 (0%)	1 of 32 (3.1%)	0 of 32
Healthy Control Participants Without Bulimia Nervosa	0 of 32 (0%)	4 of 32 (12.5%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Laura A Berner, PhD principal investigator

Department of Psychiatry, Icahn School of Medicine at Mount Sinai

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing fasting state, fed state and magnetic resonance imaging in people with Bulimia Nervosa, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brain Activation Associated With P(Stop) (time frame: after 16 hours of fasting and at 30 minutes after a standardized meal (as least 24 hours apart, but not more than 7 days apart)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04409457.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.