Effects of Ketone Supplement and Alcohol on Brain Metabolism
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age21-65
SponsorUniversity of Pennsylvania
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Crossover
Treatments tested in this trial
Kenetik
Dietary supplementKetone supplement is randomly given once.
Alcohol beverage
Other interventionAlcohol 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%
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Ketone SupplementExperimental treatment 1 intervention
Group B: Alcohol beverageExperimental treatment 1 intervention
Group C: No InterventionNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
60 minutes2
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.
Time frame
45 minutes3
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.
Time frame
75 minutesSecondary outcomes
1
To examine the acute effects of alcohol (dose adjusted by weight) 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 an alcohol (dose adjusted by weight) intervention compared to no intervention.
Time frame
60 minutes2
To examine the acute effects of alcohol (dose adjusted by weight) 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 an alcohol (dose adjusted by weight) intervention compared to no intervention.
Time frame
45 minutes3
To examine the acute effects of alcohol (dose adjusted by weight) 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 an alcohol (dose adjusted by weight) intervention compared to no intervention.
Time frame
75 minutesSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pennsylvania
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov