Effect of Nutritional Ketosis on Alcohol Metabolism

Summary

The research study is being conducted in health controls to better understand the effects of ketosis on brain functioning after 3 different, randomly assigned, 3-day dietary interventions and the acute effects of alcohol after consuming about 4-5 alcohol beverages. The labs visits will use magnetic resonance imaging (MRI) scans to study the brain, measuring levels of nicotinamide adenine dinucleotide (NAD), lactate, neurotransmitters glutamate, and Gamma-aminobutyric acid (GABA).

Conditions

• Ketoses, Metabolic
• Ketogenic Dieting
• Alcohol Intoxication
• Magnetic Resonance Imaging
• Alcohol Drinking

Interventions

DIETARY_SUPPLEMENT

Ketone Supplement

Ketone supplement 3x day with control diet for 3 days.

OTHER

Control Diet

Control Diet breakfast, lunch, and dinner for 3 days.

OTHER

Ketogenic diet

Ketogenic Diet breakfast, lunch, and dinner for 3 days.

DRUG

Ethanol

After 3 days of diet intervention, participants will receive alcohol drinks that dose-adjusts for body weight and sex differences in pharmacokinetics and calculated to obtain a final breath alcohol concentration of 0.08%

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  collaborator NIH

• University of Pennsylvania

  lead OTHER

Principal Investigators

• Corinde Wiers, Ph.D. · University of Pennsylvania

• Henry Kranzler, MD · University of Pennsylvania

• Kyle Kampman, MD · University of Pennsylvania

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

21 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-02-29

Primary Completion

2025-12-01

Completion

2026-12-01

FDA Drug

Yes

Countries

• United States

Study Locations