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

Part of paid clinical trials in Montgomery, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT07570875
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ketogenic foodstuffs — DIETARY_SUPPLEMENT
    Weekly food box, selected from rotating menu of three options, as designed by study dietician to include ketogenic foodstuffs.
  • Standard of Care Oral antipsychotics — OTHER
    Oral mood stabilizing antipsychotics for the treatment of bipolar disorder. These medications may include second generation antipsychotic mood stabilizing medications aripiprazole, risperidone, quetiapine, and olanzapine.
  • Standard of care long acting injectable medication for bipolar disorder — OTHER
    Long-acting injectable antipsychotic mood stabilizing medication for bipolar disorder. The medication used may include aripiprazole monohydrate.

Study Details

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 Dates

Start date
May 31, 2026
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Oral bipolar medication only
    Participants in this arm will receive oral medication treatment as usual for bipolar disorder. These medications may include second generation antipsychotic mood stabilizing medications aripiprazole, risperidone, quetiapine, and olanzapine.
  • Active Comparator: Long-acting injectable medication only
    Participants in this arm will receive long-acting injectable medication as treatment for bipolar disorder. This medication may include aripiprazole monohydrate.
  • Experimental: Oral medication + ketogenic diet
    Participants in this arm will receive oral medication for bipolar disorder, plus foodstuffs necessary to support ketogenic diet. Oral medications may include second generation antipsychotic mood stabilizing medications aripiprazole, risperidone, quetiapine, and olanzapine.
  • Experimental: Long-acting injectable medication + ketogenic diet
    Participants in this arm will receive long-acting injectable medication for bipolar disorder, plus foodstuffs necessary to support ketogenic diet. The medication used may include aripiprazole monohydrate.

Primary Outcome Measure

Impact on Symptom Severity as measured by Young Mania Ratings Scale [ Time Frame: T0 (time of intake); T0+1 week; T0+2 weeks; T0+3 weeks; T0+4 weeks; T0+6 weeks; T0+8 weeks; T0+10 weeks; T0+12 weeks; T0+16 weeks; T0+20 weeks; T0+24 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Baptist Medical Center SouthMontgomeryAlabama36116-2496
Will Rutland, MD
[email protected]
3347477550

Find similar trials in Montgomery, AL

By condition
Bipolar disorder
By specialty
PsychiatryMental healthBehavioral health
By research site
Baptist Medical Center South· Montgomery, AL

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