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Ketone Supplement for Alcohol Consumption Effects

Phase 2 & 3
Recruiting
Led By Corinde Wiers, PhD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 hours
Awards & highlights

Study Summary

This trial is testing whether a ketone supplement can offset the effects of alcohol.

Who is the study for?
This trial is for healthy volunteers who've had at least two drinks on one occasion in the past month. They must be under 225lbs, not have a history of significant brain-related health issues, and can't be taking medications that affect brain function or interact with alcohol. Participants should not have any major psychiatric disorders (except nicotine or marijuana use disorders) and must agree to avoid psychoactive drugs before lab procedures.Check my eligibility
What is being tested?
The study tests how a ketone supplement affects the body's response to alcohol compared to a placebo. It's conducted over two lab visits where participants consume alcohol to reach a specific breath alcohol concentration, receiving either the ketone supplement or placebo randomly during these visits.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical reactions to alcohol such as dizziness, nausea, impaired coordination, and mood changes. The ketone supplement could also cause digestive discomfort or other mild adverse effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Apnea
Secondary outcome measures
Ketones

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: ketone supplementActive Control2 Interventions
Subjects will drink single dose of ketone supplement 25g
Group II: Placebo beveragePlacebo Group1 Intervention
Subjects will drink single dose of placebo beverage that will look and taste the same as ketone supplement.

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,223 Total Patients Enrolled
Corinde Wiers, PhDPrincipal InvestigatorUniversity of Pennsylvania

Media Library

ketone supplement Clinical Trial Eligibility Overview. Trial Name: NCT05551754 — Phase 2 & 3
Alcohol Consumption Research Study Groups: Placebo beverage, ketone supplement
Alcohol Consumption Clinical Trial 2023: ketone supplement Highlights & Side Effects. Trial Name: NCT05551754 — Phase 2 & 3
ketone supplement 2023 Treatment Timeline for Medical Study. Trial Name: NCT05551754 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we able to enroll more participants in this clinical trial at this time?

"The information available on clinicaltrials.gov suggests that this clinical trial is open and recruiting patients. The listing was created on 10/20/2022 and was last updated on 10/21/2022."

Answered by AI

Could you please provide the total patient population for this trial?

"According to the latest information available on clinicaltrials.gov, this study is currently looking for recruits. The trial was first posted on October 20th, 2020 and was last updated on October 21st, 2020. They are recruiting for 10 patients from 1 site."

Answered by AI

Who meets the ideal candidate criteria for this clinical trial?

"This alcoholism study only requires that participants have a drinking problem and are within the ages of 21 and 50. 10 people will be accepted into the clinical trial."

Answered by AI

Does this research require all participants to be under the age of seventy?

"The individuals this trial is looking to recruit must be younger than 50 and older than 21."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Acute Effects of Ketone Supplement on Responses to Alcohol Challenge in Healthy Volunteers
2022. "Acute Effects of Ketone Supplement on Responses to Alcohol Challenge in Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05551754.
~3 spots leftby Dec 2024
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