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NCT07678567
Pomegranate Dietary Supplements in AUD and ALD
Conditions: Alcohol Use Disorder, Alcohol-associated Liver Disease, Alcoholic Cirrhosis, Healthy
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 144
Sponsor: University of Louisville
Location: University of Louisville Louisville Kentucky
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.
Eligibility Criteria
Healthy Group:
Inclusion: Healthy individuals, Exclusion: AUD, ALD, AC, and inflammatory conditions,
Alcohol Use Disorder Group:
Inclusion: AUD diagnosis Exclusion: alcohol-associated systemic conditions
Alcohol-associated liver disease Group:
Inclusion: early-stage ALD comorbid with AUD Exclusion: Only AUD or AUD with AC
Alcohol-associated cirrhosis Inclusion: AC with AUD Exclusion: AUD, and early stage ALD, as well as determined by the study cohort criteria
Source: ClinicalTrials.gov (NCT07678567). StuddyBuddy aggregates publicly available trial information.