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Effects of Ketone Supplementation on Brain Energetics and Alcohol Consumption in Alcohol Use Disorder (KABA)
This is a randomized, double-blind, crossover trial to evaluate the immediate effects of a nutritional ketone supplement, Kenotic compared to placebo on brain function and alcohol consumption in individuals with alcohol use disorder. Participants will complete 2 MRI scans, 2 FDG PET/CT scans, and 2 alcohol bar labs and will randomly receive Kenetik at one lab and the placebo at the next lab. During the bar labs participants will consume a dose of alcohol (based on weight), to bring their breath alcohol concentration to about 0.050%.
Details
| Lead sponsor | University of Pennsylvania |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 60 |
| Start date | 2026-06 |
| Completion | 2030-12 |
Conditions
- Alcohol Use Disorder
- Ketosis
Interventions
- Kenetik
- magnetic resonance imaging scan
- fludeoxyglucose-18 positron emission tomography scan
- Alcohol bar lab
- Placebo beverage
Primary outcomes
- To examine the effects of a single dose of KS compared to placebo on brain glucose energetics — 90 minutes
The primary outcome measure to be analyzed is a comparison of a single dose of KS versus placebo in AUD subjects in the amount of FDG uptake (CMRg metabolic rate of glucose) (mmol/L) levels in the brain. - To examine the effects of a single dose of KS compared to placebo on brain ketone energetics — 90 minutes
The primary outcome measure to be analyzed is a comparison of a single dose of KS versus placebo in AUD subjects in the amount of FDG uptake BHB (beta-hydroxybutyrate) (mmol/L) levels in the brain.
Countries
United States