Clinical Trial

Pomegranate Dietary Supplements in AUD and ALD

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Summary
The goal of this project is to determine an individual's ability to generate active gut microbial metabolites called urolithins upon consumption of pomegranate dietary supplements. Recent publications have reported that urolithins are the major active metabolites responsible for the beneficial effects of eating pomegranates, berries, or walnuts. However, the production of urolithins from the parent compound ellagic acid (EA) is dependent upon the presence of certain bacteria in the human gut. In this trial, we propose to investigate variations in gut microbiota and their capacity to metabolize pomegranate dietary supplements (PDS) into active urolithins. We will measure the levels of urolithins in blood as well as inflammatory cytokines in plasma samples upon consumption of PDS.
Protocol Amendment History 1 change
critical Primary endpoint(s) modified 2026-07-25
Trial Details
NCT Number NCT07678567
Lead Sponsor University of Louisville
Collaborators: National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions Alcohol Use Disorder, Alcohol-associated Liver Disease, Alcoholic Cirrhosis, Healthy
Enrollment 144 participants
Start Date 2027-01-01
Primary Completion 2031-06-30 (estimated)
Study Completion 2032-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-24