Pomegranate Dietary Supplements in Alcohol Use Disorder and Liver Disease
This study is looking at how your body processes a Pomegranate Dietary Supplement (Nutricost Pomegranate Extract 15,000mg Equivalent) and how it might affect conditions like Alcohol Use Disorder (AUD) and Alcohol-associated Liver Disease (ALD). Researchers want to see if your gut bacteria can turn the supplement into beneficial substances called urolithins. They will measure these urolithins and other inflammatory markers in your blood. The study is open to healthy individuals, those with AUD, and those with early-stage ALD or Alcohol-associated Cirrhosis (AC) who also have AUD. The goal is to understand how these supplements work and if individual differences in gut bacteria play a role in their effectiveness. The current status of this study is unclear.
- Study design
- This is an observational study with a planned enrollment of 144 participants. It is not specified if participants will be randomly assigned to groups or if the study is blinded.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcomes will be measured in 2036, which suggests a long-term follow-up period.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Pomegranate Dietary Supplements in AUD and ALD
At a glance
Conditions
NCT07678567
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
University of Louisville
Louisville, Kentuckystudy coordinator listed
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- 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
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- To characterize the metabolite and cytokine profiles to inform future trials designed for enhancing cut barrier function2036 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 metabolites2036 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.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.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.)