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

ConditionBipolar Disorder

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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 intervention
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 intervention
Long-acting injectable antipsychotic mood stabilizing medication for bipolar disorder. The medication used may include aripiprazole monohydrate.

Treatment groups

100 Participants

are divided into 4 treatment groups

Group A: Oral bipolar medication onlyActive comparator 1 intervention

Group B: Long-acting injectable medication onlyActive comparator 1 intervention

Group C: Oral medication + ketogenic dietExperimental treatment 2 interventions

Group D: Long-acting injectable medication + ketogenic dietExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Impact on Symptom Severity as measured by Young Mania Ratings Scale

The Young Mania Rating Scale (YMRS) is a clinical assessment tool specifically designed to evaluate manic symptoms and their severity. The YMRS comprises 11 items. Each item is rated on a scale that varies in range, typically from 0 to 4 or 0 to 8, allowing for a nuanced measurement of symptoms. The total score can range from 0 to 60, with higher scores indicating more severe manic symptoms.

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

Sponsors and contacts

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University of Alabama at Birmingham

Lead sponsor

Baszucki Family Foundation

Collaborator

Baptist Health System Montgomery

Collaborator

Source ClinicalTrials.gov

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