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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

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Dec 2026 → Apr 2027
See other at-risk trials from University of Alabama at Birmingham

Record History

  1. Start date pushed from Oct 2026 to Nov 2026 Primary completion date: Apr 2027 to May 2027 · Completion date: Oct 2027 to Nov 2027 Show 2 more changesShow less
    • Primary completion date: Apr 2027 to May 2027
    • Completion date: Oct 2027 to Nov 2027
  2. Start date: Aug 2026 to Oct 2026 Primary completion pushed from Dec 2026 to Apr 2027 · Completion pushed from Dec 2026 to Oct 2027 · Eligibility criteria expanded, about 7 words · 1 more Show 4 more changesShow less
    • Primary completion pushed from Dec 2026 to Apr 2027
    • Completion pushed from Dec 2026 to Oct 2027
    • Eligibility criteria expanded, about 7 words
    • Publications: details revised at 3 of 3 entries
  3. Start date: May 2026 to Aug 2026v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07570875
Lead Sponsor University of Alabama at Birmingham
Collaborators: Baszucki Family Foundation, Baptist Health System Montgomery
Conditions Bipolar Disorder
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov