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NCT07570875 · ClinicalTrials.gov registry record · NA
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 NA study, sponsored by University of Alabama at Birmingham.
- Not yet
- Registry status
- NA
- Development phase
- 100
- Enrollment target
NCT07570875: Clinical Trial NA study, sponsored by University of Alabama at Birmingham.
NCT07570875 is a NA study that has not yet begun recruiting, run by University of Alabama at Birmingham. The registered enrollment target is 100 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07570875, a NA study, has not yet begun recruiting, sponsored by University of Alabama at Birmingham.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Interventions
- DIETARY_SUPPLEMENT Ketogenic foodstuffs
- OTHER Standard of Care Oral antipsychotics
- OTHER Standard of care long acting injectable medication for bipolar disorder
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2026-08 |
| Est. Completion | 2026-12 |
| Phase | NA |
What is known before NCT07570875 opens enrollment
NCT07570875 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 3 interventions - of which Ketogenic foodstuffs is the first listed.
NCT07570875 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07570875 about?
NCT07570875 is a clinical study titled "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. Whil...
What is the current status of trial NCT07570875?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2026-08. Estimated completion is 2026-12.
What interventions are being tested in trial NCT07570875?
The interventions under investigation include: Ketogenic foodstuffs (DIETARY_SUPPLEMENT), Standard of Care Oral antipsychotics (OTHER), Standard of care long acting injectable medication for bipolar disorder (OTHER).
Who is sponsoring clinical trial NCT07570875?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07570875's enrollment target sits among peer trials
100 840th of 2000 higher than 1,081 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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