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Could a ketone drink help stabilize bipolar disorder?

NCT ID NCT06335875

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This small pilot study tested whether a ketone ester drink combined with a low-glycemic diet could help people with bipolar disorder. Fifteen adults with bipolar I or II took the supplement twice daily and made simple diet changes for several weeks. Researchers measured blood ketone levels and glucose stability to see if the approach was feasible and had any effect on mood symptoms.

What this could mean

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

Active substance
ketone ester beverage (Juvenescence Cognitive Switch™) and a low-glycemic-index diet
What this could lead to
If it works, this could point toward a dietary approach to help stabilize mood in bipolar disorder.
What could go wrong
This is a very small, early pilot study with only 15 people and no placebo group, so results may not be reliable or apply to everyone. The diet and supplement may be hard to stick with long-term.

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

15 people

The number who actually took part.

Started

Jun 2024

Finished

Sep 2025

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 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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 Criteria: * 18 and older * Able to provide informed consent * Diagnosis of bipolar disorder, type I or II as determined primarily via medical/psychiatric documentation provided from mental health provider with patient consent * Regular access to smart phone capable of syncing biometric wearable data collection * If taking psychiatric medications, on stable regimen as defined by no medication changes for mood stabilizers and/or antipsychotics in prior 4 weeks Exclusion Criteria: * Inability to adhere to dietary changes as specified in protocol (e.g., not in control of food selection) * History of moderate-to-severe traumatic brain injury, e.g. loss of consciousness \> 10 min, neurologic sequela * Evidence of large vessel stroke or mass lesion on previous MRI or MRI obtained during study * History of significant GI disease (e.g., malabsorptive disorder, gastric cancer, intestinal resection) * Pregnancy (as determined via urine pregnancy test at study initiation), if capable of becoming pregnant, or breastfeeding * Unwilling to utilize birth control method during course of study (e.g., barrier contraception, oral contraceptive, IUD), if capable of becoming pregnant * Currently receiving treatment with insulin (e.g., chronic pancreatitis, diabetes mellitus) * History of mitochondrial disorder and/or significant uncontrolled metabolic/medical disorder * Active/current illicit substance use (and/or consumption of \>1 alcoholic beverages per day) - defined as using psychoactive medications not as prescribed or using illicit substances (as determined via urine drug screen and screening interview) * Use of marijuana or THC products more than once monthly on average * Subjects with contra-indications to MR imaging, including pacemakers or severe claustrophobia, and/or size incompatible with scanner gantry, e. g., men over 6 feet tall that weigh more than 250 lbs, men under 6 feet tall that weigh over 220 lbs, women over 5'11" tall that weigh more than 220 lbs, or women under 5'10" tall that weigh more than 200 lbs. Subjects of these weights or greater typically have difficult fitting into the fMRI scanner properly. * Suicidal thoughts with plans or intentions, as assessed by C-SSRS * Any other condition or criteria that would preclude safe and meaningful participation in this study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Domino's Farms

    Ann Arbor, Michigan, 48105, United States

  • University Hospital

    Ann Arbor, Michigan, 48109, United States

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