About this trial
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
Qualifiers
Age >18
Verified Bipolar Diagnosis per NETSCID
Disqualifiers
Acute psychiatric instability (manic episode, active suicidality requiring hospitalization)
Anorexia
Pregnancy
Severe renal insufficiency
Trial design
Treatments tested in this trial
- Ketogenic foodstuffs
- Standard of Care Oral antipsychotics
- Standard of care long acting injectable medication for bipolar disorder
Treatment groups
Locations
1Sponsors and collaborators
University of Alabama at Birmingham
Lead sponsor
Baszucki Family Foundation
Collaborator
Baptist Health System Montgomery
Collaborator