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NCT Number: NCT07570875

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

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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baptist Medical Center South

Montgomery, Alabama, 36116-2496, United States

Location contact

Will Rutland, MD

CONTACT

[email protected]

3347477550

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >18
  • Verified Bipolar Diagnosis per NETSCID

Exclusion criteria

  • Acute psychiatric instability (manic episode, active suicidality requiring hospitalization)
  • Anorexia
  • Pregnancy
  • Severe renal insufficiency
  • Hepatic insufficiency

Treatment and study plan

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.

Primary outcomes

  1. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Will Rutland, MD

CONTACT

[email protected]

334-747-7550

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Baptist Health System Montgomery
  • Baszucki Family Foundation

Registry information

Official study title

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 - A Four-Arm Pilot Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 6, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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