[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645066":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":34,"centralContacts":44,"locations":52,"responsibleParty":77,"collaborators":80,"id":86,"slug":10,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":10,"eligibilityCriteria":91,"healthyVolunteers":92,"sex":93,"minAge":94,"maxAge":10,"enrollmentInfo":95,"targetDuration":10,"studyType":98,"phases":10,"briefSummary":99,"conditions":100,"keywords":105,"overallStatus":107,"whyStopped":10,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"University of Louisville","OTHER",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"healthy volunteers",null,"Adults ≥18, Drink no alcohol or drink \\\u003C 50 grams of alcohol per day on average if female and \\\u003C 80 grams per day on average if male; 3 capsules of the PDS (pomegranate dietary supplement - Nutricost Pomegranate Extract) - dose of 400 mg",[13],"Dietary Supplement: Pomegranate Dietary Ssupplement",{"label":15,"type":10,"description":16,"interventionNames":17},"Alcohol Use Disorder (AUD) subjects","Adults ≥18; Must consume \\>20 standardized alcoholic beverages a week for the last 3 months for men, \\>14 standard alcoholic beverages a week for women; 3 capsules of the PDS (pomegranate dietary supplement - Nutricost Pomegranate Extract) - dose of 400 mg",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Alcoho-associated Cirrhosis (AC) patients","Adults ≥18; A history of alcohol consumption averaging at least 80 grams per day in men or 50 grams per day for women for at least 10 years; 3 capsules of the PDS (pomegranate dietary supplement - Nutricost Pomegranate Extract) - dose of 400 mg",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Early-Stage Alcohol-Associated Liver Disease","Adults ≥18; AUD qualifying criteria, plus ALT\\>40. 3 capsules of the PDS (pomegranate dietary supplement - Nutricost Pomegranate Extract) - dose of 400 mg",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DIETARY_SUPPLEMENT","Pomegranate Dietary Ssupplement","Nutricost Pomegranate Extract 15,000mg Equivalent from 1,000mg of 15:1 Extract Per Servings, 120 Capsules for 40 Servings Per Bottle - Vegan, GMO Free and Gluten Free;",[19,15,23,9],[33],"Nutricost Pomegranate Extract",[35,38,41],{"name":36,"affiliation":5,"role":37},"Craig J McClain, MD","STUDY_CHAIR",{"name":39,"affiliation":5,"role":40},"Vatsalya Vatsalya, MD","STUDY_DIRECTOR",{"name":42,"affiliation":5,"role":43},"Venkatakrishna R Jala, PhD","PRINCIPAL_INVESTIGATOR",[45,49],{"name":39,"role":46,"phone":47,"phoneExt":10,"email":48},"CONTACT","502-852-8928","v0vats01@louisville.edu",{"name":42,"role":46,"phone":50,"phoneExt":10,"email":51},"502-852-5523","jvrao001@louisville.edu",[53],{"facility":5,"status":10,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Louisville","Kentucky","40202","United States","US",{"type":60,"coordinates":61},"Point",[62,63],-85.75941,38.25424,{"lat":63,"lon":62},[66,68,72,73,75],{"name":67,"role":46,"phone":47,"phoneExt":10,"email":48},"Vatsalya Vatsalya, M.D.",{"name":69,"role":46,"phone":70,"phoneExt":10,"email":71},"Steve Mahanes, M.S.","502-852-1388","steve.mahanes@louisville.edu",{"name":67,"role":43,"phone":10,"phoneExt":10,"email":10},{"name":74,"role":43,"phone":10,"phoneExt":10,"email":10},"Craig J McClain, M.D.",{"name":76,"role":43,"phone":10,"phoneExt":10,"email":10},"Ventakrishna R Jala, Ph.D.",{"type":43,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Vatsalya Vatsalya","Medical Faculty",[81,84],{"name":82,"class":83},"National Institutes of Health (NIH)","NIH",{"name":85,"class":83},"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","100645066",false,"NCT07678567","Pomegranate Dietary Supplements in AUD and ALD","Supplementation of Pomegranate Dietary Supplements and Characterization of Urolithin Metabotypes in Patients With Alcohol Use Disorder (AUD) and Alcohol-associated Liver Disease (ALD)","Healthy Group:\n\nInclusion: Healthy individuals, Exclusion: AUD, ALD, AC, and inflammatory conditions,\n\nAlcohol Use Disorder Group:\n\nInclusion: AUD diagnosis Exclusion: alcohol-associated systemic conditions\n\nAlcohol-associated liver disease Group:\n\nInclusion: early-stage ALD comorbid with AUD Exclusion: Only AUD or AUD with AC\n\nAlcohol-associated cirrhosis Inclusion: AC with AUD Exclusion: AUD, and early stage ALD, as well as determined by the study cohort criteria",true,"ALL","18 Years",{"count":96,"type":97},144,"ESTIMATED","OBSERVATIONAL","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.",[101,102,103,104],"Alcohol Use Disorder","Alcohol-associated Liver Disease","Alcoholic Cirrhosis","Healthy",[106],"Pomeragranate, AUD, ALD","NOT_YET_RECRUITING","2026-06-30",{"date":110,"type":111},"2026-07-02","ACTUAL",{"date":113,"type":97},"2027-01-01",{"date":115,"type":97},"2032-12-31",{"name":5,"class":6},1]