Effects of Ketone Supplement and Alcohol on Brain Metabolism
Acute Effects of Ketone Supplementation and Alcohol on Brain Metabolism
2 other identifiers
interventional
60
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2025
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2025
CompletedFirst Posted
Study publicly available on registry
February 7, 2025
CompletedStudy Start
First participant enrolled
May 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2029
March 25, 2026
March 1, 2026
4.1 years
February 3, 2025
March 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
To examine the acute effects of ketone supplements compared to no intervention on Nicotinamide adenine dinucleotide levels in the brain.
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.
60 minutes
To examine the acute effects of ketone supplements compared to no intervention on brain Glutamate levels.
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.
45 minutes
To examine the acute effects of ketone supplements compared to no intervention on brain Gamma-aminobutyric acid levels.
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.
75 minutes
Secondary Outcomes (3)
To examine the acute effects of alcohol (dose adjusted by weight) compared to no intervention on Nicotinamide adenine dinucleotide levels in the brain.
60 minutes
To examine the acute effects of alcohol (dose adjusted by weight) compared to no intervention on brain Glutamate levels.
45 minutes
To examine the acute effects of alcohol (dose adjusted by weight) compared to no intervention on brain Gamma-aminobutyric acid levels.
75 minutes
Study Arms (3)
Ketone Supplement
EXPERIMENTALSubjects will receive ketone supplement once by mouth, 20g of kentones.
Alcohol beverage
EXPERIMENTALAlcohol lab, participants will receive ethanol drinks that are dose-adjusted for body weight and sex differences in pharmacokinetics and calculated to obtain a final breath alcohol concentration of 0.050%
No Intervention
NO INTERVENTIONNo intervention will be given
Interventions
Ketone supplement is randomly given once.
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%
Eligibility Criteria
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)
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Studies of Addiction
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Corinde Wiers, Ph.D.
University of Pennsylvania
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2025
First Posted
February 7, 2025
Study Start
May 13, 2025
Primary Completion (Estimated)
May 31, 2029
Study Completion (Estimated)
May 31, 2029
Last Updated
March 25, 2026
Record last verified: 2026-03