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NCT07570875Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 7 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
100 (estimated)
First submitted
22 Apr 2026
Start date
1 Nov 2026
Primary completion date
31 May 2027
Lead sponsor
University of Alabama at Birmingham
NCT number
NCT07570875

What you commit to

  • Study type: Interventional
  • Planned participants: 100
  • From 1 Nov 2026 to the primary completion date, 31 May 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

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

Other

  • Anorexia
  • Pregnancy

Who the study is looking for

  • Age \>18
  • Verified Bipolar Diagnosis per NETSCID

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Baptist Medical Center South
Coordinator of this site? Confirm its status
MontgomeryUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.