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RecruitingNCT07115862

Effects of Pomegranate Juice on Ulcerative Colitis

Effect of Pomegranate Juice on Gut Inflammation, Quality of Life and the Gut Microbiome in Patients With Ulcerative Colitis: A Pilot Study

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
University of California, Los Angeles · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to determine whether consumption of 237 ml of pomegranate juice daily for 8 weeks will: 1. lower inflammation (in the gut as well as generally in the body) and improve your overall quality of life 2. affect the microbes living in the gut (gut microbiota)

Detailed description

the study is aimed at evaluating the effects of pomegranate juice (PomJ) on: 1) gut inflammation (fecal calprotectin and Simple Clinical Colitis Activity Index) and quality of life; 2) circulating inflammatory markers (e.g., hs-CRP, IL-6, IL-10, TNF-a, IL-1b, IL-8, LBP, LPS) and markers of oxidative stress (blood and urine malondialdehyde (MDA)) and 3) gut microbiota composition and functionality (urinary and circulating urolithin metabolites, fecal SCFAs/BAs, blood LBP and LPS, etc.). We will perform a randomized, controlled, 16-week trial to generate preliminary evidence on the effects of PomJ consumption in patients with mild-to-moderate UC. Participants will be randomly assigned to one of two groups: intervention group and delayed start group. The study will involve 2 phases, each lasting for 8 weeks. During Phase 1, the intervention group will consume 237 ml of PomJ daily, while the delayed start group will follow their habitual diet. Data generated from the delayed start group during Phase 1 will serve as the control for the study. During Phase 2, the intervention group will stop consuming PomJ and switch to consuming their habitual diet, while the delayed start group will consume 237 ml of PomJ daily for 8 weeks. Data generated from the intervention group during Phase 2 will serve as a follow-up to explore whether the effects of PomJ consumption persist after consumption is stopped (this will be an exploratory outcome).

Conditions

Interventions

TypeNameDescription
OTHERpomegranate juice -> habitual diet237 ml of pomegranate juice for the first 8 weeks -\> habitual diet for the second 8 weeks
OTHERhabitual diet -> pomegranate juicehabitual diet for the first 8 weeks -\> 237 ml of pomegranate juice for the second 8 weeks

Timeline

Start date
2025-10-15
Primary completion
2027-10-15
Completion
2027-10-15
First posted
2025-08-11
Last updated
2025-12-09

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT07115862. Inclusion in this directory is not an endorsement.