About this trial
The research study is being conducted to better understand the effects of ketosis on brain functioning and the acute effects of alcohol. Participants will be asked to undergo \~4 weeks of ketogenic diet intervention. The study involves three lab visits: Lab 1 before starting the diet, Lab 2 after about 2 weeks after starting the diet, and Lab 3 after being on the diet for 4 weeks. All of the labs will include an alcohol tolerance test, and blood draws. Lab 1 and Lab 3 will also include an Magnetic resonance imaging scan. Due to scheduling, study procedures at 2 and 4 weeks may occur +/- 3 days. Magnetic resonance imaging (MRI) of the brain will measure levels of nicotinamide adenine dinucleotide (NAD) (a coenzyme that is important for energy metabolism), lactate (a metabolite produced during energy metabolism), and neurotransmitters glutamate and GABA. Alcohol tolerance will be tested using a dose of alcohol (approximately 4-5 alcohol beverages) to will elevate breath alcohol levels to approximately 0.08% to measure the acute effects of alcohol. Blood samples will be collected to measure varying metabolites.
Eligibility criteria
Qualifiers
Age 21 years to 50 years old.
Willingness to provide signed, informed consent and commit to completing study procedures. Reported on at least one day in the month prior to consent of consuming 2 or more standard alcohol drinks on a single day.
Disqualifiers
Unwilling or unable to refrain from use, within 24 hours of the alcohol lab procedures, psychoactive medications or medication that may affect study results.
Current DSM-5 diagnosis of any major psychiatric disorder (other than nicotine use disorders, or marijuana 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 medication(s) that could interfere with study participation or make it hazardous for the subject to participate. (e.g. anticholinergics; antipsychotics; lithium; psychotropic drugs not otherwise specified)
Positive urine drug screen, positive for all substances but marijuana at screening or study visits (may be repeated once and if the result is negative on repeat, it is not exclusionary).
Trial design
Treatments tested in this trial
- Ketogenic diet
Treatment groups
Sponsors and collaborators
University of Pennsylvania
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator