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Not Yet Recruiting NCT07570875

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

Conditions: Bipolar Disorder

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: University of Alabama at Birmingham

Location: Baptist Medical Center South Montgomery Alabama

Summary

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.

Eligibility Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07570875). StuddyBuddy aggregates publicly available trial information.