NCT06815237 · University of Pennsylvania
Effects of Ketone Supplement and Alcohol on Brain Metabolism
What this study is about
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.
View original scientific description
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).
Interventions
DIETARY_SUPPLEMENT
Kenetik
Ketone supplement is randomly given once.
OTHER
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 measures
To examine the acute effects of ketone supplements compared to no intervention on Nicotinamide adenine dinucleotide levels in the brain.
Time frame: 60 minutes
Use MRI imaging to measure the amount of Nicotinamide adenine dinucleotide levels in the brain measured in mmol/L in participants after receiving ketone supplement intervention compared to no intervention.
To examine the acute effects of ketone supplements compared to no intervention on brain Glutamate levels.
Time frame: 45 minutes
Use MRI imaging to measure the amount of Glutamate levels in the brain measured in mmol/L in participants after receiving ketone supplement intervention compared to no intervention.
To examine the acute effects of ketone supplements compared to no intervention on brain Gamma-aminobutyric acid levels.
Time frame: 75 minutes
Use MRI imaging to measure the amount of Gamma-aminobutyric acid levels in the brain measured in mmol/L in participants after receiving ketone supplement intervention compared to no intervention.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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
- Philadelphia, Pennsylvania
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 25, 2026 · Source of record for eligibility and locations