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
- Diseases
- Bipolar disorder
- 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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Baptist Medical Center South Coordinator of this site? Confirm its status | Montgomery | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.