Alcohol Use DisorderNCT07678567
Pomegranate Dietary Supplements in AUD and ALD
An observational study of Alcohol Use Disorder and Alcohol-associated Liver Disease, run by University of Louisville at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder, Alcohol-associated Liver Disease, Alcoholic Cirrhosis
- What is being tested?
- Pomegranate Dietary Ssupplement
- Type of treatment
- Pill or oral medicine
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 31 Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Young adults and up with open population specifics, qualifying for each cohort requirements
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Louisville
Louisville, Kentucky, 40202
Vatsalya Vatsalya, M.D., 502-852-8928, v0vats01@louisville.edu
Steve Mahanes, M.S., 502-852-1388, steve.mahanes@louisville.edu
About this study
Official title: Supplementation of Pomegranate Dietary Supplements and Characterization of Urolithin Metabotypes in Patients With Alcohol Use Disorder (AUD) and Alcohol-associated Liver Disease (ALD)
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.
Read the detailed description
A large body of anecdotal evidence suggests beneficial effects for many botanical dietary supplements (BDS) on human health. The U.S. alone spent ~$7.5 billion on BDS in 2016, suggesting significant interest in the consumption of such products. Since ancient times, pomegranate has been known as a 'healing food', with numerous health benefits, including prevention of health risk factors for high blood pressure, arthritis, high cholesterol, oxidative stress, and hyperglycemia (1-4). Despite reported benefits from consumption of pomegranate dietary supplements (PDS), the overall outcomes of clinical trials were not uniform, and the results were inconclusive (5-7). However, gut microbial metabolites derived from polyphenolics of pomegranate have been shown to promote many beneficial activities, including anti-oxidative and anti-inflammatory activities (8- 12). Thus, the inter-individual variation in human gut microbiota compositions and their metabolic capacities may hamper the predicted PDS-mediated benefits. We postulate that harboring the specific gut microbiota responsible for metabolizing PDS into beneficial metabolites is critical to manifesting the complete benefits of PDS consumption. Recently, we reported one such microbial metabolite, 'urolithin A' (UroA), derived from ellagic acid-rich diets (e.g., pomegranate), significantly enhanced gut barrier function in addition to blocking unwarranted inflammation in colitis models (13) and protected from alcoholic liver disease (ALD) in mouse models (unpublished data). UroA is produced only in 40-50% of humans, who harbor the appropriate microbiota capable of converting consumed ellagic acid-rich diets (such as pomegranates, berries, and walnuts). UroA levels varied significantly among populations, to micromolar levels in some individuals. The direct correlations between UroA levels and human health/disease conditions are not yet available.
This project aims to determine an individual's ability to generate active gut microbial metabolites called urolithins upon consumption of pomegranate dietary supplements. We, and others, reported that urolithins are the major active metabolites that are responsible for the beneficial activities that are rendered from 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.
- Being tested
- Pomegranate Dietary Ssupplement
- Keywords
- Pomeragranate, AUD, ALD
- Medical subject headings
- Alcoholism, Liver Cirrhosis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pomegranate Dietary SsupplementDietary supplement
Also called Nutricost Pomegranate Extract
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Dietary Supplement: Pomegranate Dietary Ssupplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.)
Measured: 2036 yr.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start1 Jan 2027 (estimated)
- Primary completion30 Jun 2031 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Vatsalya Vatsalya, University of Louisville
- Investigators
- Craig J McClain, MD, Study chair, University of LouisvilleVatsalya Vatsalya, MD, Study director, University of LouisvilleVenkatakrishna R Jala, PhD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678567
- Sponsor's protocol ID
- 21.0999
- Other IDs
- 2P50AA024337
- Status last verified
- Jul 2026
- First submitted
- 24 Jun 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study data can be obtained by contacting the NIH NDA system
Publications
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.
PubMed 41635923
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementation of Pomegranate Dietary Supplements and Characterization of Urolithin Metabotypes in Patients With Alcohol Use Disorder (AUD) and Alcohol-associated Liver Disease (ALD)
- ClinicalTrials.gov ID
- NCT07678567
- Acronym / sponsor ID
- 21.0999
- Keywords
- Pomeragranate, AUD, ALD
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 30 Jun 2031 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A large body of anecdotal evidence suggests beneficial effects for many botanical dietary supplements (BDS) on human health. The U.S. alone spent ~$7.5 billion on BDS in 2016, suggesting significant interest in the consumption of such products. Since ancient times, pomegranate has been known as a 'healing food', with numerous health benefits, including prevention of health risk factors for high blood pressure, arthritis, high cholesterol, oxidative stress, and hyperglycemia (1-4). Despite reported benefits from consumption of pomegranate dietary supplements (PDS), the overall outcomes of clinical trials were not uniform, and the results were inconclusive (5-7). However, gut microbial metabolites derived from polyphenolics of pomegranate have been shown to promote many beneficial activities, including anti-oxidative and anti-inflammatory activities (8- 12). Thus, the inter-individual variation in human gut microbiota compositions and their metabolic capacities may hamper the predicted PDS-mediated benefits. We postulate that harboring the specific gut microbiota responsible for metabolizing PDS into beneficial metabolites is critical to manifesting the complete benefits of PDS consumption. Recently, we reported one such microbial metabolite, 'urolithin A' (UroA), derived from ellagic acid-rich diets (e.g., pomegranate), significantly enhanced gut barrier function in addition to blocking unwarranted inflammation in colitis models (13) and protected from alcoholic liver disease (ALD) in mouse models (unpublished data). UroA is produced only in 40-50% of humans, who harbor the appropriate microbiota capable of converting consumed ellagic acid-rich diets (such as pomegranates, berries, and walnuts). UroA levels varied significantly among populations, to micromolar levels in some individuals. The direct correlations between UroA levels and human health/disease conditions are not yet available.
This project aims to determine an individual's ability to generate active gut microbial metabolites called urolithins upon consumption of pomegranate dietary supplements. We, and others, reported that urolithins are the major active metabolites that are responsible for the beneficial activities that are rendered from 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | – | Dietary Supplement: Pomegranate Dietary SsupplementAdults ≥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 |
| Alcohol Use Disorder (AUD) subjects | – | Dietary Supplement: Pomegranate Dietary SsupplementAdults ≥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 |
| Alcoho-associated Cirrhosis (AC) patients | – | Dietary Supplement: Pomegranate Dietary SsupplementAdults ≥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 |
| Early-Stage Alcohol-Associated Liver Disease | – | Dietary Supplement: Pomegranate Dietary SsupplementAdults ≥18; AUD qualifying criteria, plus ALT>40. 3 capsules of the PDS (pomegranate dietary supplement - Nutricost Pomegranate Extract) - dose of 400 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Young adults and up with open population specifics, qualifying for each cohort requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pomegranate Dietary SsupplementAlso: Nutricost Pomegranate ExtractNutricost 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; | Dietary supplement | Alcoho-associated Cirrhosis (AC) patients, Alcohol Use Disorder (AUD) subjects, Early-Stage Alcohol-Associated Liver Disease, healthy volunteers |
Primary outcome
To characterize the metabolite and cytokine profiles to inform future trials designed for enhancing cut barrier function
Time frame: 2036 yr.
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).
If inter-individual variation in gut microbiome is responsible for the production of beneficial metabolites
Time frame: 2036 yr.
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.
To determine if more correlative studies between produced metabolites, inflammatory mediators, and disease conditions could provide informed decisions during disease progression.
Time frame: 2036 yr.
Develop identifiers for the pathology and treatment development of the study cohorts.
To evaluate the omics of the subject and the microbiomes in their saliva, urine, and stool.
Time frame: 2036 yr.
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.)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Background: PubMed 41635923Ghosh 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.
- Individual participant dataSharing planned: Yes. Study data can be obtained by contacting the NIH NDA system
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Craig J McClain, MD study chair
University of Louisville
Vatsalya Vatsalya, MD study director
University of Louisville
Venkatakrishna R Jala, PhD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Use Disorder and Alcohol-associated Liver Disease, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vatsalya Vatsalya, MD (502-852-8928, v0vats01@louisville.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To characterize the metabolite and cytokine profiles to inform future trials designed for enhancing cut barrier function (time frame: 2036 yr.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07678567, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.