Actively Recruiting
Acute Effects of Ketone Supplementation and Alcohol on Brain Metabolism
Led by University of Pennsylvania · Updated on 2026-03-25
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Pennsylvania
Lead Sponsor
N
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how ketone supplements and alcohol affect brain function and metabolism using brain imaging technology. The study aims to better understand the acute effects of these substances on brain chemicals such as Nicotinamide adenine dinucleotide, Glutamate, and Gamma-aminobutyric acid. Participants include adults who consume alcohol and are able to complete study procedures, with the research sponsored by the University of Pennsylvania. Participants will undergo three separate visits, each involving one of three interventions given in random order: a ketone supplement drink containing 20 grams of ketones, an alcoholic beverage adjusted by body weight and sex to reach a breath alcohol concentration of 0.050%, or no intervention. Each visit starts early in the morning with fasting from midnight, followed by assessments, administration of the intervention or no intervention, and a brain MRI scan. After the scan, participants are monitored until their breath alcohol and blood glucose levels return to safe ranges. During the study, participants attend a screening visit with medical history, physical exam, blood and urine tests, psychiatric assessments, and an HIV test. On lab days, vital signs, breathalyzer tests, blood glucose, ketone levels, and urine tests are performed. A follow-up phone call checks on health and side effects the day after each visit. The study measures brain chemical levels at specific times after interventions to understand their acute effects. Participation lasts for the screening plus three lab visits and follow-up calls.
CONDITIONS
Brief Title
Effects of Ketone Supplement and Alcohol on Brain Metabolism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide written informed consent and commit to completing study procedures.
- Reported consuming 2 or more standard alcoholic drinks on a single day at least once in the month before consent.
- Adults aged 21 to 65 years.
- Able to attend all study visits and procedures.
You will not qualify if you...
- Unwilling or unable to refrain from psychoactive medications, alcohol, or medications affecting study results within 24 hours of lab visits.
- Current major psychiatric disorder (other than marijuana or nicotine use disorder) interfering with participation.
- Taking medications that may interfere with participation or safety (e.g., anticholinergics, antipsychotics).
- Positive urine drug screen for substances other than marijuana on study visits (repeat allowed once).
- Clinically significant physical diseases or abnormalities including bleeding disorders, pancreatitis, epilepsy, liver or kidney disease, diabetes, or abnormal liver labs.
- Major gastrointestinal diseases like GERD, Crohn's disease, Irritable bowel syndrome, Ulcerative colitis, Celiac disease, Diverticulitis.
- History of head trauma with loss of consciousness over 30 minutes.
- Pregnant or breastfeeding.
- Weight greater than 250 pounds.
- Self-reported claustrophobia.
- Contraindications to MRI such as non-removable metal implants or incompatible devices.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) including medical history, physical exam, blood and urine tests, psychiatric interview, and informed consent
Duration - 3 lab visits scheduled after screening, each lasting approximately 4 hours
Participants receive one of three interventions in a randomized crossover design: a ketone supplement, an alcohol beverage dose-adjusted for body weight and sex, or no intervention. Each treatment visit includes fasting, vital signs measurements, blood glucose and ketone testing, urine tests, MRI scans, and safety assessments.
3 lab visits (in-person) with each visit starting at 8:30 AM; includes fasting, light breakfast, MRI scan, multiple blood glucose and breathalyzer tests, and post-visit safety assessments; alcohol visits require Lyft transportation to and from the site
Duration - Approximately 5 minutes per follow-up call after each lab visit
Participants receive a follow-up phone call on the first business day after each study lab visit to check for any health changes or side effects from the procedures.
Phone call follow-up on the first business day after each lab visit
Trial Site Locations
Total: 1 location
1
Center for Studies of Addiction
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
T
Timothy Pond, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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