Pomegranate Dietary Supplements in AUD and ALD

NCT07678567 | Not Yet Recruiting

• 2 other identifiers: 21.09992P50AA024337
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcohol Use Disorder; Alcohol-associated Liver Disease; Alcoholic Cirrhosis; Healthy

Keywords

Pomeragranate, AUD, ALD

Outcome Measures

Primary Outcomes (4)

• To characterize the metabolite and cytokine profiles to inform future trials designed for enhancing cut barrier function

  To evaluate the impact of pomegranate dietary supplements (PDS) on gut microbiome composition and epithelial barrier function in healthy, alcohol use disorder (AUD), early-stage ALD (eALD), and alcohol-associated liver cirrhosis (AC) subjects by characterizing the metabolite and cytokine profiles to inform future trials designed for enhancing cut barrier function in alcohol-associated liver disease (ALD).

  2036 yr.

• If inter-individual variation in gut microbiome is responsible for the production of beneficial metabolites

  To determine if inter-individual variation in gut microbiome is responsible for the production of beneficial metabolites in healthy, AUD, eALD, and AC patients by correlating urolithin levels to inflammatory mediators in both healthy and diseased conditions.

  2036 yr.

• To determine if more correlative studies between produced metabolites, inflammatory mediators, and disease conditions could provide informed decisions during disease progression.

  Develop identifiers for the pathology and treatment development of the study cohorts.

  2036 yr.

• To evaluate the omics of the subject and the microbiomes in their saliva, urine, and stool.

  To evaluate the omics of the subject and the microbiomes in their saliva, urine, and stool. This will help determine what response changes are genetic changes (both bacterial and human) in saliva; and omics, and genetic changes in stool and urine (both human and bacterial) could illustrate their role in profiling these potential modifiable risk factors for AUD/ALD. The data could be correlated with the blood sample-derived cytokine, gut dysfunction, and candidate biomarkers of liver (K18s) and AUD severity (neurotransmitters, such as dopamine, GABA, serotonin, etc.)

  2036 yr.

Study Arms (4)

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

Dietary Supplement: Pomegranate Dietary Ssupplement

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

Dietary Supplement: Pomegranate Dietary Ssupplement

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

Dietary Supplement: Pomegranate Dietary Ssupplement

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

Dietary Supplement: Pomegranate Dietary Ssupplement

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;

Also known as: Nutricost Pomegranate Extract

Alcoho-associated Cirrhosis (AC) patients; Alcohol Use Disorder (AUD) subjects; Early-Stage Alcohol-Associated Liver Disease; healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Young adults and up with open population specifics, qualifying for each cohort requirements

You may not qualify if:

• Alcohol Use Disorder Group:
• Alcohol-associated liver disease Group:

Sponsors & Collaborators

• University of Louisville: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Related Publications (1)

• Ghosh S, Singh R, Vanwinkle ZM, McClain CJ, Vatsalya V, Haribabu B, Vemula PK, Jala VR. Urolithin A regulates gut: liver axis to ameliorate alcohol-associated liver disease. Front Pharmacol. 2026 Jan 19;16:1706111. doi: 10.3389/fphar.2025.1706111. eCollection 2025.

  PMID: 41635923 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine, fecal, and blood

MeSH Terms

Conditions

Alcoholism; Liver Cirrhosis, Alcoholic

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Liver Cirrhosis; Liver Diseases; Digestive System Diseases; Liver Diseases, Alcoholic; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Alcohol-Induced Disorders

Study Officials

• Craig J McClain, MD

  University of Louisville

  STUDY CHAIR

• Vatsalya Vatsalya, MD

  University of Louisville

  STUDY DIRECTOR

• Venkatakrishna R Jala, PhD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vatsalya Vatsalya, MD

CONTACT

502-852-8928; v0vats01@louisville.edu

Venkatakrishna R Jala, PhD

CONTACT

502-852-5523; jvrao001@louisville.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Faculty

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 1, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): June 30, 2031
• Study Completion (Estimated): December 31, 2032
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: 2034 Onwards
• Access Criteria: Contact the Investigators for approval to upload the NDA issuance data.

Locations

US (1)