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

Alcohol Drinking Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

The purpose of the study is to evaluate the immediate subjective and objective effects of alcohol after consuming a ketone supplement beverage, compared to a placebo beverage (an inactive substance). Participants will not know which lab they receive the ketone drink, however they will be asked to drink an alcohol beverage (based on weight), to bring breath alcohol concentration (BrAC) to about 0.050% at each lab visit.

The goal of the study is to see how measure subjective effects of alcohol, once after drinking the ketone supplement and once after drinking a placebo beverage. The study will use questionnaires, blood, and breath alcohol tests to see how subjects body and brain experience alcohol. The study is also interested in if the ketone supplement makes people want to drink alcohol more or less.

Consent and Screening Session (approximately 3 hrs)

The following will occur at the screening session, following signed consent:

• First, subjects will be asked to show a legal photo ID and then undergo a breathalyzer test to ensure that they are able to make a well-reasoned decision about whether or not to participate in the study. The BrAC must be at 0.000% to complete this visit.

• Demographic information, such as date of birth, age, biological sex, marital status, education, race, and ethnicity will be collected.

• Subjects will be asked to provide current information about address and contact information to register them as a patient at the University of Pennsylvania, if they have not been a patient here before.

• Approximately 2 tablespoons of blood for standard laboratory tests will be drawn. It is possible that bloodwork will need to be repeated due to unforeseen events (abnormal findings or potential lab errors).

• Subject's will be asked to provide a urine sample for routine urinalysis, drug screen, and a pregnancy test in women who are able to become pregnant.

• Study personnel will measure vital signs (blood pressure and pulse), weight, and height. Subject's will be asked to complete a questionnaire about current and past medical history and any medications currently taking.

• Study personnel will complete a brief psychiatric interview and ask about alcohol and cigarette use over the past 90 days.

Staff will confirm eligible within 5 business days after the screening visit, to schedule the rest of the study visits.

Lab visits (approximately 5 1/2 hrs) The following will occur on the day of the two lab visits as a participant.

• Subject's are asked to not eat or drink anything except water after midnight the day before and on the day of the lab visit. A light meal will be provided on the lab days, after staff takes a BrAC (must be 0.000% to continue), preforms a finger stick for blood glucose level (must be below 140), measures weight, and vital signs.

• Subjects will be asked to provide a urine sample to conduct a drug screen, and a pregnancy test (for woman able to become pregnant).

• Staff will review the current list medications and vitamins provided at the screening visit and ask if anything has changed?

• Subjects will be asked about alcohol and drug use history since the last visit.

• Approximately 1 hour after the light meal, subjects will be asked to drink the ketone supplement or placebo beverage.

• Approximately 30 minutes after drinking the beverage, subjects will be asked to drink an alcohol beverage based on weight in 15 minutes. Staff will record the BrAC, draw blood and ask subjects to complete questionnaire as listed in the below table.

• Staff will ask about any side effects that may occur throughout the lab procedures.

• During the lab day between study procedures, subjects may read books, magazines, or watch videos.

• After a snack, staff will check the final BrAC and ask again about any side effects. The second visit will be scheduled at least 2 days after the first visit and will follow the same procedures. Subjects may leave with a BrAC below 0.010.

Table of assessments on Lab Visits:

• Approximate study times • Procedure

• 10:30am • BrAC1, vital signs, urine sample

• 10:40am • light meal

• 11:00am • Review of medications currently taking, and review of alcohol and drug use since last visit

• 12:00pm • Ketone supplement or placebo drink

• 12:20pm • BrAC 2, and 3 questionnaires

• 12:30pm • Finger stick

• Alcohol administration

• 12:45pm • BrAC 3, and blood draw 1

• 1:00pm • BrAC 4, and 2 questionnaires

• 1:15pm • BrAC 5, and blood draw 2

• 1:30pm • BrAC 6, and 2 questionnaires

• 2:00pm • BrAC 7, Blood draw 3, and 3 questionnaires

• 2:30pm • BrAC 8

• 3:00pm • BrAC 9

• 3:30pm • BrAC 10, blood draw 4, and 3 questionnaires

• 3:50pm • Snack

• 4:00pm • Final BrAC end of visit.

Follow-up Visit (approximately 5 minutes): A follow-up phone call will occur the day after each lab visit and the following will occur:

• Staff will ask about any side effects that may have been experienced. ;

Related Conditions & MeSH terms

• Alcohol Drinking

• NCT number: NCT05551754
• Study type: Interventional
• Source: University of Pennsylvania
• Contact: Timothy S Pond, MPH
• Phone: 2157461959
• Email: timpond@pennmedicine.upenn.edu
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: October 20, 2022
• Completion date: July 2025