Ketone Supplement + Alcohol for Brain Metabolism
TP
Overseen ByTimothy Pond, MPH
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Waitlist Available
Sponsor: University of Pennsylvania
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The research study is being conducted to better understand the effects of ketones and alcohol on brain functioning and brain metabolism. Participants will be asked to undergo three identical MRI visits after three single-dose interventions: (1) drink a ketone supplement drink, (2) drink an alcoholic beverage, (3) no intervention. These interventions will be randomly assigned (meaning everyone receives all 3 interventions, but in different orders).
Research Team
CW
Corinde Wiers, Ph.D.
Principal Investigator
University of Pennsylvania
Eligibility Criteria
This trial is for individuals who are interested in understanding how ketones and alcohol affect brain function. Participants will undergo MRI scans after consuming a ketone supplement, an alcoholic beverage, or having no intervention at all.Inclusion Criteria
Able to provide written informed consent and commit to completing study procedures
I have had 2 or more drinks in one day in the last month.
Exclusion Criteria
I am claustrophobic.
Head trauma with loss of consciousness for more than 30 minutes (self-report, medical history)
Pregnant or breast-feeding
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Treatment Details
Interventions
- Alcohol beverage (Other)
- Kenetik (Ketone Supplement)
Trial OverviewThe study tests the effects of a single dose of a ketone supplement (Kenetik) and an alcoholic beverage on brain metabolism by comparing them to no intervention using MRI technology. Each participant will experience all three scenarios in random order.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Ketone SupplementExperimental Treatment1 Intervention
Subjects will receive ketone supplement once by mouth, 20g of kentones.
Group II: Alcohol beverageExperimental Treatment1 Intervention
Alcohol lab, participants will receive ethanol drinks that are dose-adjusted for body weight and sex differences in pharmacokinetics and calculated to obtain a final breath alcohol concentration of 0.050%
Group III: No InterventionActive Control1 Intervention
No intervention will be given
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Who Is Running the Clinical Trial?
University of Pennsylvania
Lead Sponsor
Trials
2,118
Recruited
45,270,000+
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Trials
865
Recruited
1,091,000+