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Ketogenic Diet for Alcohol Metabolism (KAM Trial)

Phase 2 & 3

Recruiting

Led By Corinde Wiers, Ph.D.

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 3 hours

Awards & highlights

KAM Trial Summary

This trial will study the effects of ketosis and alcohol on brain functioning using MRI scans and other measurements.

Who is the study for?

This trial is for healthy individuals who have consumed at least two alcoholic drinks on one occasion in the past month. They must be willing to follow study procedures and diets, not exceed a weight of 225lbs, and can't be using medications or substances that affect the study. Pregnant or breastfeeding women, those with certain medical conditions or psychiatric disorders, and anyone with MRI contraindications are excluded.Check my eligibility

What is being tested?

The study tests how a ketogenic diet affects brain function during ketosis and after consuming alcohol (4-5 beverages). Participants will undergo three different dietary interventions over three days each: a ketogenic diet, ethanol intake, ketone supplements, versus a control diet. Brain activity is monitored using MRI scans.See study design

What are the potential side effects?

Potential side effects may include discomfort from dietary changes such as nausea or constipation due to the ketogenic diet; intoxication symptoms from alcohol consumption; reactions to ketone supplements like stomach upset; and possible claustrophobia or discomfort during an MRI scan.

KAM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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

Change in breath alcohol concentration

Secondary outcome measures

Change in cognitive performance tasks

Change in motor agility tasks

KAM Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Ketone supplementExperimental Treatment2 Interventions

Eat a control diet for 3 days with a ketone supplement drink

Group II: Ketogenic dietExperimental Treatment1 Intervention

Eat a ketogenic diet for 3 days

Group III: Alcohol InterventionExperimental Treatment3 Interventions

Alcohol lab, participants will receive ethanol drinks that are dose-adjusted for body weight and sex differences in pharmacokinetics and calculated to obtain a final breath alcohol concentration of 0.08%

Group IV: Control DietPlacebo Group1 Intervention

Eat a control diet for 3 days

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ethanol

2005

Completed Phase 4

~3000

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,005 Previous Clinical Trials

42,882,267 Total Patients Enrolled

5 Trials studying Metabolic Syndrome

642 Patients Enrolled for Metabolic Syndrome

Kyle Kampman, MDStudy DirectorUniversity of Pennsylvania

3 Previous Clinical Trials

185 Total Patients Enrolled

Henry Kranzler, MDStudy DirectorUniversity of Pennsylvania

Frequently Asked Questions

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

Is there an age limitation for participation in this trial?

"As indicated by the inclusion criteria, qualified applicants must be between 21 and 50 years old. 38 medical studies are available for those under 18 while 247 exist for participants over 65."

Answered by AI

For whom is enrollment available in this research project?

"Candidates who are 21 - 50 years old and have a history of alcohol consumption may qualify for this clinical trial. In total, 20 people will be accepted to participate in the study."

Answered by AI

Are there presently openings for study participants in this trial?

"According to clinicaltrials.gov, this medical experiment has not been recruiting since September 29th 2023 and is no longer actively searching for participants. However, there are still 356 other trials in search of patients at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of Nutritional Ketosis on Alcohol Metabolism

2023. "Effect of Nutritional Ketosis on Alcohol Metabolism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06065657.

All > Metabolic Syndrome