Recruiting
Phase 2
Phase 3

Ketone & Alcohol

Sponsor:

University of Pennsylvania

Code:

NCT06815237

Conditions

Ketosis

Alcohol Drinking

MRI

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Accepted

Interventions

Kenetik

Alcohol beverage

Study Details

Brief summary:

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).

Conditions

Ketosis

Alcohol Drinking

MRI

Study ID

NCT06815237

Start date

May 13, 2025

Status verified date

Mar, 2026

Completion date

May 31, 2029

Anticipated

Primary completion date

May 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Able to provide written informed consent and commit to completing study procedures.
2. Reported on at least one day in the month before consent of consuming 2 or more standard alcoholic drinks on a single day.

Exclusion Criteria:

1. Unwilling or unable to refrain from the use of psychoactive medications, medication that may affect study results, and or alcohol, within 24 hours of the Alcohol lab, and MRI procedures (self-report, medical history, UDS, and breathalyzer).
2. Current DSM-5 diagnosis of a major psychiatric disorder (other than marijuana and nicotine use disorders) as identified by clinical examination or structured interview that could interfere with study participation or make it hazardous for the subject.
3. Currently taking a medication that could interfere with study participation or make it hazardous for the subject to participate. (e.g., anticholinergics; antipsychotics; psychotropic drugs not otherwise specified)
4. Positive urine drug screen positive for all substances but marijuana on study visits (may be repeated once and if the result is negative on repeat it is not exclusionary).
5. A current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation that could interfere with study participation or make it hazardous for the subject to do so (e.g., bleeding disorder, pancreatitis, epilepsy, liver disease, kidney disease, or diabetes as determined by history and clinical exam); ALAT or ASAT concentration greater than 3 times the upper limit of normal (ULN), or bilirubin above the ULN. (Note-abnormal laboratory tests during screening may be repeated once).
6. Current, major gastrointestinal (GI) diseases, such as: GERD, Crohn's disease, Irritable bowel syndrome, Ulcerative colitis, Celiac disease Diverticulitis, or other clinically significant physical disease that may interfere with the intake of the Ketone Supplement based on medical history, and evaluation of the Study Physician.
7. Head trauma with loss of consciousness for more than 30 minutes (self-report, medical history).
8. Pregnant or breast-feeding
9. Weight greater than 250lbs (Need to cap amount of alcohol give based on weight to individuals).
10. Self-reported claustrophobia
11. Contraindications to MRI (e.g., metal in the body that cannot be removed and is not MRI compatible).

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Ketone Supplement

Subjects will receive ketone supplement once by mouth, 20g of kentones.

experimental: Alcohol beverage

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%

no intervention: No Intervention

No intervention will be given

Interventions

Kenetik

Ketone supplement is randomly given once.

Alcohol beverage

Alcohol beverage is randomly given once. Participants will receive the alcohol beverage that dose-adjusts for body weight and sex differences in pharmacokinetics and calculated to obtain a final breath alcohol concentration of 0.050%

Primary outcome measure

  • To examine the acute effects of ketone supplements compared to no intervention on Nicotinamide adenine dinucleotide levels in the brain. [ Time Frame: 60 minutes ]
  • To examine the acute effects of ketone supplements compared to no intervention on brain Glutamate levels. [ Time Frame: 45 minutes ]
  • To examine the acute effects of ketone supplements compared to no intervention on brain Gamma-aminobutyric acid levels. [ Time Frame: 75 minutes ]

Central Contacts and Locations

Central contacts

Locations

Center for Studies of Addiction

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Principal Investigator:

Corinde Wiers, Ph.D

More Information

Sponsor

University of Pennsylvania

Last update posted

Mar 25, 2026

Last verified

Mar, 2026

Keywords

  • ketone supplement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-03-25.