Actively Recruiting
Effects of Ketogenic Diet on Alcohol Intoxication
Led by University of Pennsylvania · Updated on 2026-05-22
20
Participants Needed
1
Research Sites
52 weeks
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
This research aims to better understand how a ketogenic diet affects brain function and the immediate effects of alcohol. The study focuses on adults aged 21 to 50 who have consumed at least two alcoholic drinks on one day in the past month. Researchers will measure changes in brain chemicals and alcohol tolerance during and after the diet period. Participants will follow a ketogenic diet for about four weeks, receiving all meals from a commercial meal service. The study includes three lab visits: before starting the diet, about two weeks after starting, and after approximately four weeks on the diet. During these visits, participants will undergo alcohol tolerance tests, blood draws, and brain MRI scans to measure brain metabolites and neurotransmitters. Compliance with the diet is monitored daily through urine ketone tests and weekly phone check-ins. Participants will visit the lab for detailed assessments, including breath alcohol tests, cognitive and motor tasks, blood and urine samples, and MRI brain scans lasting about 1.5 hours. They will have meals provided during visits and transportation arranged via Lyft. Researchers will track alcohol effects, blood glucose, ketone levels, mood, and side effects throughout the study. The total commitment includes screening, diet adherence, and three main lab visits spread over four weeks.
CONDITIONS
Brief Title
Effects of Ketogenic Diet on Alcohol Intoxication
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 21 years to 50 years old
- Willingness to provide signed, informed consent and complete all study procedures
- Reported consuming 2 or more standard alcoholic drinks on at least one day in the month prior to consent
You will not qualify if you...
- Unable or unwilling to refrain from psychoactive medications within 24 hours of alcohol lab tests
- Current major psychiatric disorder diagnosis (except nicotine or marijuana use disorders)
- Taking medications that may interfere with participation or safety (e.g. anticholinergics, antipsychotics, lithium)
- Positive urine drug screen for substances other than marijuana at screening or visits
- Significant physical disease or abnormality affecting brain function or diet use (e.g. epilepsy, diabetes, liver or kidney disease)
- History of stroke or stroke-related spasticity
- Head trauma with loss of consciousness over 30 minutes or skull injury
- Weight over 225 pounds
- Pregnant or breastfeeding females
- Contraindications to MRI including metal implants, claustrophobia, or inability to lie flat for up to 2 hours
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, approximately 4 hours)
Duration - 4 weeks
Participants follow a ketogenic diet for 4 weeks, receiving all meals by delivery. Daily urine ketone tests and weekly health check calls are conducted to monitor compliance, mood, and alcohol use.
Daily urine ketone tests at home; weekly phone calls
Duration - 3 visits over 4 weeks
Participants attend three laboratory visits during the ketogenic diet. Visits include breath alcohol tests, blood and urine sampling, MRI brain scans, alcohol administration, cognitive and motor tests, and monitoring of side effects.
1 visit at Week 2 (~5 hours), 2 visits at Week 4 (~8 hours each)
Trial Site Locations
Total: 1 location
1
Center for Studies of Addiction
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
T
Timothy S Pond, MPH
C
Cindy Li, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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