Pomegranate Dietary Supplements in AUD and ALD

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
University of Louisville
Study ID
NCT07678567
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Pomegranate Dietary Ssupplement — DIETARY_SUPPLEMENT
    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;

Study Details

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.

Key Dates

Start date
Jan 1, 2027
Status verified
Jun 2026
Primary completion
Jun 30, 2031
Completion
Dec 31, 2032

Study Design

Enrollment
144 participants (estimated)

Arms

  • Arm: healthy volunteers
    Adults ≥18, Drink no alcohol or drink \< 50 grams of alcohol per day on average if female and \< 80 grams per day on average if male; 3 capsules of the PDS (pomegranate dietary supplement - Nutricost Pomegranate Extract) - dose of 400 mg
  • Arm: 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
  • Arm: 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
  • Arm: 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

Primary Outcome Measure

To characterize the metabolite and cytokine profiles to inform future trials designed for enhancing cut barrier function [ Time Frame: 2034 yr. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of LouisvilleLouisvilleKentucky40202
Vatsalya Vatsalya, M.D.
[email protected]
502-852-8928
Steve Mahanes, M.S.
[email protected]
502-852-1388
Vatsalya Vatsalya, M.D. (PRINCIPAL_INVESTIGATOR)
Craig J McClain, M.D. (PRINCIPAL_INVESTIGATOR)
Ventakrishna R Jala, Ph.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Louisville, KY

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
University of Louisville· Louisville, KY

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