Effects of Ketones on Brain Energetics and Alcohol Consumption in Alcohol Use Disorder

Summary

This is a randomized, double-blind, crossover trial to evaluate the immediate effects of a nutritional ketone supplement, Kenotic compared to placebo on brain function and alcohol consumption in individuals with alcohol use disorder. Participants will complete 2 MRI scans, 2 FDG PET/CT scans, and 2 alcohol bar labs and will randomly receive Kenetik at one lab and the placebo at the next lab. During the bar labs participants will consume a dose of alcohol (based on weight), to bring their breath alcohol concentration to about 0.050%.

Conditions

• Alcohol Use Disorder
• Ketosis

Interventions

DIETARY_SUPPLEMENT

Kenetik

Drink a single dose of ketone supplement 25g, three times, randomly given at 1 of 2 MRI scan visits, 1 of 2 FDG PET/CT scan visits, and 1 of 2 alcohol bar lab visits.

OTHER

magnetic resonance imaging scan

Each subject will undergo 2 research MRI scan evaluations of the brain (up to 90 min.). The MRI is FDA-approved 7.0T Magentom Prisma scanner (Siemens Medical Solutions USA, Inc., Malvern, PA) with an approved radiofrequency head coil.

OTHER

fludeoxyglucose-18 positron emission tomography scan

Each subject will undergo 2 FDG PET/CT scans. FDG is a positron emitting radiopharmaceutical. In addition to the radioactive FDG tracer, a low-dose CT of the chest is typically performed with the FDG PET/CT for the purpose of anatomical registration and attenuation correction of PET images. There are no separate diagnostic CT scans performed as part of this study.

OTHER

Alcohol bar lab

Each subject will undergo 2 alcohol bar labs. Subjects will drink about 2 ½ standard alcohol beverages, based on their weight to reach a breath alcohol level of 0.050%.

OTHER

Placebo beverage

Drink a single dose of placebo beverage, that will look and taste the same as the ketone supplement. Subjects will recieve the beverage three times, randomly given at 1 of 2 MRI scan visits, 1 of 2 FDG PET/CT scan visits, and 1 of 2 alcohol bar lab visits, opisite of the Kenetik beverage.

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

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

21 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-30

Primary Completion

2029-12-31

Completion

2030-12-31

Countries

• United States

Study Locations