Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Could a High-Fat diet tame bipolar mood swings? new study investigates

NCT ID NCT06081426

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Researchers at the University of Pittsburgh are studying how a ketogenic diet—a high-fat, low-carb eating plan—affects brain activity, metabolism, and mood in adults with bipolar disorder. The study will compare people with bipolar disorder who follow either a ketogenic or non-ketogenic diet, along with a group of healthy volunteers who do not change their diet. The goal is to understand the brain mechanisms behind any mood changes, not to test the diet as a proven treatment.

What this could mean

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

Active substance
ketogenic diet
What this could lead to
If successful, this study could reveal how a ketogenic diet changes brain function and metabolism in bipolar disorder, pointing toward a new dietary approach to help manage the condition.
What could go wrong
This is an early-stage mechanistic study, not a treatment trial. It is small (107 people) and focuses on understanding brain changes, not proving the diet works as a therapy. Results may not lead to a practical treatment.

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 107 people

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

Started

Jan 2024

Expected to finish

Jan 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 40 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 Criteria: All participants: * 18-40 years of age * Not following a ketogenic diet BD hypomanic group (n=30): * Meeting sex proportion: 50% female * Meeting diagnosis proportion: 50:50% Bipolar I: Bipolar II (BDI:II) (Diagnostic and Statistical Manual of Mental Disorders 5; DSM-5) * Score greater than 10 on the Young Mania Rating Scale score(YMRS) * BD medications will be allowed as in our previous studies: any combination of atypical antipsychotics, lithium, antidepressants, anxiolytics (common in BD) BD euthymic group (n=30): * Meeting sex proportion: 50% female * Meeting diagnosis proportion: 50:50% BDI:II (DSM-5) * Score less than or equal to 10 on YMRS * BD medications will be allowed as in our previous studies: any combination of atypical antipsychotics, lithium, antidepressants, anxiolytics (common in BD) Healthy Control (HC) Group (n=30): * Sex matched with BD groups * No psychiatric history Exclusion Criteria: All participants: * Not between 18-40 years of age * History of head injury, neurological, pervasive developmental disorder (e.g. autism), systemic medical disease and treatment (medical records, participant report) * Mini-Mental State Examination score (cognitive state) \<24 * Premorbid National Adult Reading Test Intelligent Quotient (NAART IQ) estimate\<85 * Visual disturbance: \<20/40 Snellen visual acuity * History of alcohol/substance use disorder (SUD; all substances, including nicotine), and/or illicit substance use (except cannabis) over the last 6 months (SCID-5). Note: lifetime/present cannabis use (at non-abuse (\<3 times in the past month) and non SUD levels) will be allowed, given its common usage in BD and young adults. Cannabis SUD over the last 6 months will not be allowed. Urine tests on scan days will exclude current illicit substance use (except cannabis). Salivary alcohol tests on scan days will exclude intoxicated individuals * MRI exclusion: metallic objects, e.g., surgical implants; claustrophobia; positive pregnancy test for females or self-report pregnancy * Unable to understand English * Conditions related to the pancreas, liver, thyroid or gallbladder. * Taking anticoagulants and/or those with blood dyscrasias (illnesses) who have coagulation disorders (eg, hemophilia) because of the ketomojo finger stick blood tests * Scoring 3 or higher on positive symptom factor questions on the Positive and Negative Syndrome Scale (PANSS) questionnaire (indicative of psychotic symptoms) * Currently following a ketogenic diet * Head circumference larger than 24 inches (62cm) and/or chest circumference larger than 55 inches (139 cm) BD hypomanic group: * Must be meeting sex proportions: not 50% female * Must be meeting diagnosis proportions: not 50:50% BDI:II (DSM-5) * Diagnosis of BD in a manic or euthymic episode * Score 10 or lower on the Young Mania Rating Scale score(YMRS) * Using psychotropic medications other than those allowed in inclusion criteria * Does not have a smartphone with a) iOS version 12.0 or above, or b) Android version 8 and later to use with the Keto-Mojo app BD euthymic group: * Not meeting sex proportion: not 50% female * Not meeting diagnosis proportion: not 50:50% BDI:II * Diagnosis of BD in a depressive, hypomanic, or manic episode * Score greater than 10 on YMRS * Using psychotropic medications other than those allowed in inclusion criteria * Does not have a smartphone with a) iOS version 12.0 or above, or b) Android version 8 and later to use with the Keto-Mojo app Healthy Control (HC) Group * Not sex-matched with BD groups * Has psychiatric history

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Bipolar disorder are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

How to take part

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

  1. The places running it

    1 site. 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

  • University of Pittsburgh Medical Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.