Food as medicine: keto diet tested for bipolar disorder in rural south
NCT ID NCT07570875
First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This pilot study will test whether a high-fat, low-carbohydrate ketogenic diet can reduce symptoms of bipolar disorder when added to standard treatments. The study will enroll 100 adults in rural Alabama and measure changes in mania severity. The goal is to see if a dietary approach can improve access to effective care in underserved areas.
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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 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
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 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age \>18 * Verified Bipolar Diagnosis per NETSCID Exclusion Criteria: * Acute psychiatric instability (manic episode, active suicidality requiring hospitalization) * Anorexia * Pregnancy * Severe renal insufficiency * Hepatic insufficiency
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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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Baptist Medical Center South
Montgomery, Alabama, 36116-2496, United States
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Other studies related to the condition(s) this trial covers.
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