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Ketogenic diet added to usual treatment for bipolar disorder in rural Alabama

Tests a ketogenic diet alongside usual care for bipolar disorder in adults.

Plain-language title generated from the registry record
Registry title: Evaluating the Impact of Ketogenic Therapy on Symptom Severity and Metabolic Side Effect Profile Among Individuals Living With Bipolar Disorder in A Rural Southern Catchment Area

Key facts

Where
Montgomery, United StatesSee the site

Where in United States

  • Baptist Medical Center SouthMontgomery, United StatesNo longer taking part

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Trial details

Who runs it
University of Alabama at Birmingham
Trial code
NCT07570875
Record updated
7 October 2026
Original description
It is the purpose of this pilot study to evaluate a high-fat/low-carbohydrate "ketogenic" diet-based intervention as an adjunctive strategy for impacting symptoms of bipolar disorder. The study is designed to evaluate this impact in the rural southern catchment area around Montgomery, Alabama.Read full original descriptionShow less

Evaluating the Impact of Ketogenic Therapy on Symptom Severity and Metabolic Side Effect Profile Among Individuals Living With Bipolar Disorder in A Rural Southern Catchment Area - A Four-Arm Pilot Study

It is the purpose of this pilot study to evaluate a high-fat/low-carbohydrate "ketogenic" diet-based intervention as an adjunctive strategy for impacting symptoms of bipolar disorder. The study is designed to evaluate this impact in the rural southern catchment area around Montgomery, Alabama.

While existing access and cost barriers can prevent effective treatment of bipolar disorder in the rural south, using food as medicine represents a possible alternative/adjunctive to traditional high-cost/low-access medications. Specifically, this study will evaluate the impact of combining a ketogenic diet with existing treatment options, under the conditions of the rural catchment area, to determine the impact and efficacy of this intervention at patient and systems levels.

If effective, the interventions examined in this pilot study may increase the efficacy, availability and access to care experienced by individuals living with bipolarity in the rural Deep South.

Inclusion: Age >18; Verified Bipolar Diagnosis per NETSCID.

Exclusion: Acute psychiatric instability (manic episode, active suicidality requiring hospitalization); Severe renal insufficiency; Hepatic insufficiency; Anorexia; Pregnancy.

ClinicalTrials.gov NCT07570875