NCT06815237 Effects of Ketone Supplement and Alcohol on Brain Metabolism
| NCT ID | NCT06815237 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | University of Pennsylvania |
| Condition | Ketosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-05-13 |
| Primary Completion | 2029-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2025-05-13 with a primary completion date of 2029-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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).
Contact & Investigator
Corinde Wiers, Ph.D.
PRINCIPAL INVESTIGATOR
University of Pennsylvania
Frequently Asked Questions
Who can join the NCT06815237 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 65 Years, studying Ketosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06815237 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06815237 currently recruiting?
Yes, NCT06815237 is actively recruiting participants. Contact the research team at timpond@Pennmedicine.upenn.edu for enrollment information.
Where is the NCT06815237 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT06815237 clinical trial?
NCT06815237 is sponsored by University of Pennsylvania. The principal investigator is Corinde Wiers, Ph.D. at University of Pennsylvania. The trial plans to enroll 60 participants.