Effects of Ketone Supplement and Alcohol on Brain Metabolism

Recruiting now · Phase 2/Phase 3

Conditions studied: Ketosis, Alcohol Drinking, MRI

In brief

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).

Key facts

Study ID

NCT06815237

Run by

University of Pennsylvania

People needed

60

Starts

2025-05-13

Expected to finish

2029-05-31

Last updated by the study team

2026-03-25

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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).
• 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.
• 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)
• 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).
• 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).
• 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.
• Head trauma with loss of consciousness for more than 30 minutes (self-report, medical history).
• Pregnant or breast-feeding
• Weight greater than 250lbs (Need to cap amount of alcohol give based on weight to individuals).
• Self-reported claustrophobia
• Contraindications to MRI (e.g., metal in the body that cannot be removed and is not MRI compatible).

Where it is running

• Center for Studies of Addiction — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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