Pomegranate Dietary Supplements in AUD and ALD
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Louisville
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Young adults and up with open population specifics, qualifying for each cohort requirements
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Pomegranate Dietary Ssupplement
Dietary supplementNutricost 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;
Treatment groups
144 Participants
are divided into 4 treatment groupsGroup A: healthy volunteers1 intervention
Group B: Alcohol Use Disorder (AUD) subjects1 intervention
Group C: Alcoho-associated Cirrhosis (AC) patients1 intervention
Group D: Early-Stage Alcohol-Associated Liver Disease1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
2036 yr.2
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.
Time frame
2036 yr.3
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.
Time frame
2036 yr.4
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.)
Time frame
2036 yr.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Louisville
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: