Health TrialsbyHealthPanel

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

ConditionsAlcohol Use DisorderKetosis
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age21-65
SponsorUniversity of Pennsylvania

About this trial

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%.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 21-65 years old

Able to provide written informed consent

Meets current DSM-5 criteria for mild to moderate (established using MINI)

Average weekly alcohol consumption of at least 15 standard drinks over the past month before consent (self-report)

Disqualifiers

Unwilling or unable to refrain from use of alcohol, within 24 hours of Alcohol Bar Lab, MRI and PET procedures (self-report, breathalyzer).

Use of psychoactive medications or medications that may affect study results (self-report, medical history).

Current DSM-5 diagnosis of a major psychiatric disorder (other than alcohol, Marijuana, and nicotine use disorders) that required hospitalization or daily medication in the past year.

Current significant alcohol withdrawal symptoms in the past 12 months that required medical treatment (self-report, medical history).

Trial design

Design model

Crossover

Treatments tested in this trial

  • Kenetik

    Dietary supplement

    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.

  • magnetic resonance imaging scan

    Other intervention

    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.

  • fludeoxyglucose-18 positron emission tomography scan

    Other intervention

    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.

  • Alcohol bar lab

    Other intervention

    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%.

  • Placebo beverage

    Other intervention

    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.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Ketone Supplement, KenetikActive comparator 3 interventions
Group B: Placebo BeveragePlacebo comparator 3 interventions
Group C: Alcohol beverageExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

To examine the effects of a single dose of KS compared to placebo on brain glucose energetics

The primary outcome measure to be analyzed is a comparison of a single dose of KS versus placebo in AUD subjects in the amount of FDG uptake (CMRg metabolic rate of glucose) (mmol/L) levels in the brain.

Time frame
90 minutes
2

To examine the effects of a single dose of KS compared to placebo on brain ketone energetics

The primary outcome measure to be analyzed is a comparison of a single dose of KS versus placebo in AUD subjects in the amount of FDG uptake BHB (beta-hydroxybutyrate) (mmol/L) levels in the brain.

Time frame
90 minutes

Secondary outcomes

1

To determine the effects of KS compared to placebo on alcohol pharmacokinetics and subjective responses following an alcohol priming dose.

The outcome measure to be analyzed is a comparison of breath ethanol levels (grams/210liters of breath) in response to a priming dose of alcohol following administration of KS vs. placebo.

Time frame
3 hours
2

To determine the effects of KS compared to placebo on alcohol consumption.

The outcome measure to be analyzed is a comparison of the number of alcohol drinks consumed during the bar lab, following the administration of KS vs. placebo.

Time frame
2 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pennsylvania

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: