Effect of Nutritional Ketosis on Alcohol Metabolism

Last updated: January 16, 2025
Sponsor: University of Pennsylvania
Overall Status: Active - Recruiting

Phase

2/3

Condition

Alcohol Use Disorder

Treatment

Ketone Supplement

Control Diet

Ethanol

Clinical Study ID

NCT06065657
853707
24446
  • Ages 21-50
  • All Genders
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Willingness to provide signed, informed consent and commit to completing studyprocedures.

  2. Reported on at least one day in the month prior to consent of consuming 2 or morestandard alcohol drinks on a single day.

Exclusion

Exclusion Criteria:

  1. Unwilling or unable to refrain from use, within 24 hours of the alcohol labprocedures, psychoactive medications or medication that may affect study results.

  2. Current Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)diagnosis of any major psychiatric disorder (other than nicotine use disorders, ormarijuana use disorders) as identified by clinical examination or structuredinterview that could interfere with study participation or make it hazardous for thesubject.

  3. Currently taking medication(s) that could interfere with study participation or makeit hazardous for the subject to participate. (e.g. anticholinergics; antipsychotics;lithium; psychotropic drugs not otherwise specified)

  4. Positive urine drug screen, positive for all substances but marijuana at screeningor study visits (may be repeated once and if the result is negative on repeat, it isnot exclusionary).

  5. A current, clinically significant physical disease or abnormality on the basis ofmedical history, or routine laboratory evaluation that can impact brain function,the use of a ketone supplement, administration of ketogenic diet, or the use ofalcohol (e.g., epilepsy, diabetes, irritable bowel syndrome, Crohn's disease, liverdisease, kidney disease, kidney stones, chronic metabolic acidosis or acardiomyopathy as determined by history and clinical exam).

  6. Currently suffering from or has a history of stroke and/or stroke relatedspasticity.

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

  8. Weight greater than 225lbs (Need to cap amount of alcohol given based on weight toindividuals).

  9. Females who are pregnant or breast-feeding

  10. Contraindication to MRI, including presence of ferromagnetic objects, claustrophobiaor fear of enclosed, medical conditions that prevent subjects from lying comfortablyflat on his/ her back for up to 2 hrs.

Study Design

Total Participants: 20
Treatment Group(s): 4
Primary Treatment: Ketone Supplement
Phase: 2/3
Study Start date:
February 29, 2024
Estimated Completion Date:
December 31, 2026

Study Description

The research study is being conducted to better understand the effects of ketosis on brain functioning and the acute effects of alcohol. Healthy participants will undergo three randomly assigned dietary interventions, each lasting three days, followed by a study lab visit day on day 4. The three interventions are: (1) Eat a ketogenic diet for 3 days, (2) eat a control diet for 3 days with a ketone supplement drink, and (3) eat a control diet for 3 days. The dietary interventions will be spaced 1 week apart. The ketone supplement drink (Kenetik, Vitanav inc, Washington DC) is a dietary supplement that has been extensively studied in humans and is designated by the FDA as Generally Recognized as Safe (GRAS). Its use in this study is experimental. On the day of the 3 labs visits days, magnetic resonance imaging (MRI) will be used to study the brain. Specifically, levels of nicotinamide adenine dinucleotide (NAD) (a coenzyme that is important for energy metabolism), lactate (a metabolite produced during energy metabolism), and neurotransmitters glutamate and GABA. Following the scans, participants will be provided a dose of alcohol that will elevate participants breath alcohol levels to approximately 0.08% to measure the acute effects of alcohol.

Connect with a study center

  • University of Pennsylvania Center for Studies of Addiction

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

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