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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

Must not have

Head trauma with loss of consciousness for more than 30 minutes or associated with skull fracture, inter-cranial bleeding or abnormal MRI (self-report, medical history).

Females who are pregnant or breast-feeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 hours

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I've had a severe head injury with loss of consciousness, skull fracture, or abnormal MRI results.

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I am not pregnant or breastfeeding.

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I have had a stroke or suffer from muscle stiffness due to a stroke.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in breath alcohol concentration

Secondary study objectives

Change in cognitive performance tasks

Change in motor agility tasks

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

0 / 3Eligibility criteria met