Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ACTIVE NOT RECRUITING

NCT05551754

PHASE2/PHASE3

Acute Effects of Ketone Supplement on Responses to Alcohol Challenge in Healthy Volunteers

Sponsor: University of Pennsylvania

View on ClinicalTrials.gov

Summary

This is a single blinded, randomized trial to evaluate the immediate subjective and objective effects of alcohol after a dose ketone supplement compared to a placebo in 10 health volunteers. Subjects will complete 2 lab visits where they consume a dose of alcohol (based on weight), to bring their breath alcohol concentration to about 0.050%. Participants will randomly receive ketone supplement at one lab and the placebo at the next lab.

Official title: Acute Effects of Ketone Supplementation on Subjective and Objective Responses to Alcohol in Healthy Volunteers

Key Details

Gender

All

Age Range

21 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2022-10-20

Completion Date

2027-07

Last Updated

2026-01-20

Healthy Volunteers

Yes

Conditions

Alcohol Drinking

Interventions

DIETARY_SUPPLEMENT

Ketone Supplement

Drink a single dose of ketone supplement 25g

OTHER

Alcohol Beverage

Subjects will drink about 2 ½ standard alcohol beverages, based on their weight to reach a breath alcohol level of 0.050%

Inclusion Criteria: 1. Willingness to provide signed, informed consent and commit to completing the alcohol lab studies. 2. All subjects must report at least one occasion in the prior month of drinking at least 2 drinks on a single day. Exclusion Criteria: 1. Unwilling or unable to refrain from use, within 24 hours of alcohol lab procedures, psychoactive medications or medications that may affect study results. 2. Current DSM-5 diagnosis of a major psychiatric disorder (other than nicotine use disorders, or marijuana use disorders) (identified by clinical examination or the structured interview) that could interfere with study participation or make it hazardous for the subject. 3. Currently taking a medication 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) 4. 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). 5. A baseline breath alcohol concentration of greater than 0.00% on study visit prior to alcohol tolerance test 6. A current, clinically significant physical disease or abnormality on the basis of medical history, or routine laboratory evaluation that can impact brain function, the use of a ketone supplement or the use of alcohol (e.g., epilepsy, diabetes, irritable bowel syndrome, Crohn's disease, liver disease, kidney disease, kidney stones, chronic metabolic acidosis or a cardiomyopathy as determined by history and clinical exam). 7. Currently suffering from or with a history of stroke and/or stroke related spasticity. 8. Head trauma with loss of consciousness for more than 30 minutes or associated with skull fracture or inter-cranial bleeding or abnormal MRI. (self-report, medical history). 9. Weight greater than 225lbs (Need to cap amount of alcohol give based on weight to individuals). 10. Judged by the principal investigator or his designee to be an unsuitable candidate for study participation.

Locations (1)

University of Pennsylvania Center for Studies of Addiction

Philadelphia, Pennsylvania, United States