How a ketone drink and alcohol change brain metabolism
Acute Effects of Ketone Supplementation and Alcohol on Brain Metabolism
We will try a single ketone drink, an alcoholic drink, and no drink in adults who drink alcohol to see how each affects brain metabolism on MRI.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 21 Years to 65 Years |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06815237 on ClinicalTrials.gov |
What this trial studies
This randomized crossover protocol has each participant complete three identical MRI visits after receiving one of three single-dose interventions in randomized order: a ketone supplement drink, an alcoholic beverage, or no intervention. Screening includes informed consent, breath alcohol testing, medical history, physical exam, vital signs, bloodwork, urinalysis, and urine toxicology. Eligible participants report at least one day in the prior month with two or more standard alcoholic drinks; exclusions include current major psychiatric disorders, interfering medications, positive drug screens, or inability to abstain before visits. Primary outcomes are MRI measures of brain metabolism and function collected at the Center for Studies of Addiction in Philadelphia, PA.
Who should consider this trial
Good fit: Adults who report at least one day in the prior month of consuming two or more standard alcoholic drinks, who can abstain from alcohol and certain medications before visits, and who pass medical and toxicology screening.
Not a fit: People with current major psychiatric disorders, those taking medications that would interfere with participation, those with positive drug screens, or non-drinkers would likely not benefit from this protocol.
Why it matters
Potential benefit: If successful, this could reveal how ketone supplements change brain energy use compared with alcohol and help guide strategies to protect or support brain function in people who drink.
How similar studies have performed: Prior research shows ketone supplements can alter brain energy metabolism and alcohol changes brain function on MRI, but combining single-dose ketone versus alcohol in a randomized crossover MRI protocol is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Philadelphia, Pennsylvania
- Center for Studies of Addiction — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Corinde Wiers, Ph.D. — University of Pennsylvania
- Study coordinator: Timothy Pond, MPH
- Email: timpond@Pennmedicine.upenn.edu
- Phone: 215-746-1959
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.