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Could a ketone drink calm the bipolar brain?

NCT ID NCT06373016

Knowledge-focused Sponsor: Stony Brook University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how two types of energy—glucose and ketones—change brain activity and behavior in people with bipolar disorder. Participants will have MRI scans while playing money-winning games, before and after drinking either glucose or ketones. Researchers will compare results between people with bipolar disorder and healthy volunteers to understand how the brain uses energy differently.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Glucose and ketone drinks
What this could lead to
If successful, this could reveal how diet-based energy sources like ketones might stabilize brain networks in bipolar disorder, pointing toward future dietary or metabolic therapies.
What could go wrong
This is an early-stage observational study with only 100 participants, not a treatment trial. Results may not lead to direct clinical changes or apply to all people with bipolar disorder.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion/Exclusion Criteria: * Bipolar disorder diagnosis: Patients must have a Diagnostic Statistical Manual (DSM)-V diagnosis of bipolar disorder on the Structured Clinical Interview for DSM (SCID) * Bipolar disorder symptoms: Patients must be stable and euthymic at time of consent and testing, documented by no hospitalizations in the prior 4 weeks * Age: between 18-45 yrs for patients with bipolar disorder and age-matched controls * Weight does not exceed 350lbs. * Diameter does not exceed 60 cm when supine * HbA1C \< 7% * No non-MRI-compatible metal in the body (e.g., pacemaker, shrapnel, joint pins) * No claustrophobia * No history of significant head injury * No history of electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within the last 3 months * No history of previous treatment with following procedures: vagus nerve stimulation, or deep brain stimulation * Are not deemed a serious suicide or homicide risk * No unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease * No seizure disorders * Have the capacity to sign informed consent * No current diagnosis or history of an alcohol or substance use disorder in the last 6 months or positive test for an illicit drug on the screening urine analysis (positive cannabis screen is not exclusionary): confirmed using urine toxicology test during the initial screening visit and before each MRI scan visit. * For Healthy Volunteers Only: No psychotropic medication and no history of neurological disease * Must have vision that is 20/20 or correctable to 20/20 with contact lenses * No Type 1 diabetes mellitus * No regular consumption of insulin and other antidiabetics, like Metformin®, GLP1-RA's and others. * No kidney disease, as determined by medical history and/or blood work * No history of heart attack or stroke * No difficulty swallowing * No myxedema * No Pregnancy (pre-menopausal females): confirmed during medical screening and each MRI scan visit using a urine test * No breastfeeding

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Conditions

The condition(s) this trial relates to.

bipolar disorder bipolar I disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bipolar disorder Bipolar disorder type 1

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Laufer Center for Physical and Quantitative Biology , Stony Brook University

    ACTIVE_NOT_RECRUITING

    Stony Brook, New York, 11794, United States

  • Martinos Center for Biomedical Research, Building 149, 13th Street

    RECRUITING

    Charlestown, Massachusetts, 02129, United States

  • McLean Hospital

    RECRUITING

    Belmont, Massachusetts, 02478, United States

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