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
Starting soon · Not applicable
Conditions studied: Bipolar Disorder
In brief
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.
Key facts
- Study ID
- NCT07570875
- Run by
- University of Alabama at Birmingham
- People needed
- 100
- Starts
- 2026-08-01
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-07-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age >18
- Verified Bipolar Diagnosis per NETSCID
You may not qualify if…
- Acute psychiatric instability (manic episode, active suicidality requiring hospitalization)
- Anorexia
- Pregnancy
- Severe renal insufficiency
- Hepatic insufficiency
Where it is running
- Baptist Medical Center South — Montgomery, Alabama, United States
Full record on ClinicalTrials.gov
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