Could a High-Fat diet tame bipolar mood swings? new study investigates
NCT ID NCT06081426
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
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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
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About 107 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 40 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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University of Pittsburgh Medical Center
RECRUITINGPittsburgh, Pennsylvania, 15213, United States
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