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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alabama at Birmingham

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

100 Participants
are divided into 4 treatment groups

Sponsors and collaborators

University of Alabama at Birmingham

Lead sponsor

Baszucki Family Foundation

Collaborator

Baptist Health System Montgomery

Collaborator