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Recruiting Phase 2, Phase 3 NCT06065657

Effect of Nutritional Ketosis on Alcohol Metabolism

Trial Parameters

Condition Ketoses, Metabolic
Sponsor University of Pennsylvania
Study Type INTERVENTIONAL
Phase Phase 2, Phase 3
Enrollment 20
Sex ALL
Min Age 21 Years
Max Age 50 Years
Start Date 2024-02-29
Completion 2029-05-31
Interventions
Ketone SupplementControl DietKetogenic diet

Brief 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 Criteria: 1. Willingness to provide signed, informed consent and commit to completing study procedures. 2. Reported on at least one day in the month prior to consent of consuming 2 or more standard alcohol drinks on a single day. Exclusion Criteria: 1. Unwilling or unable to refrain from use, within 24 hours of the alcohol lab procedures, 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, or marijuana use disorders) as identified by clinical examination or structured interview that could interfere with study participation or make it hazardous for the subject. 3. Currently taking medication(s) that could interfere with study participation or make it hazardous for the subject to participate. (e.g. anticholinergics; antipsychotics; lithium; psychotropic drugs not otherwise specified) 4. Positive

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