Effects Ketone Supplement and Alcohol on Brain Metabolism

Launched by UNIVERSITY OF PENNSYLVANIA · Feb 3, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how ketone supplements and alcohol affect the brain's functioning and metabolism. Participants in the study will take part in three visits where they will receive one of three treatments: a ketone drink, an alcoholic beverage, or no treatment at all. The order in which they receive these treatments will be randomly assigned, meaning everyone will experience all three, but in a different sequence. The goal is to see how each of these drinks impacts the brain, using MRI scans to gather information.

To be eligible for this trial, participants need to be between the ages of 16 and 40 and must be able to provide written consent and complete the study procedures. They should have consumed at least two standard alcoholic drinks on a single day in the month before joining. However, there are some important exclusions; for instance, individuals with certain psychiatric disorders, major physical health issues, or those who cannot refrain from specific medications or alcohol before the study visits will not be able to participate. If you decide to join, you can expect to undergo MRI scans and be part of an important research effort to understand how these substances affect the brain.

Gender

ALL

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).