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Effects of Pomegranate Juice on Ulcerative Colitis
NCT07115862 · University of California, Los Angeles
In plain English
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Official title
Effect of Pomegranate Juice on Gut Inflammation, Quality of Life and the Gut Microbiome in Patients With Ulcerative Colitis: A Pilot Study
About this study
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).
Eligibility criteria
Inclusion Criteria:
* • Adults ≥ 18 yo
* Following a low-polyphenol and fiber diet (\< 3 servings of fruits/vegetables per day)
* Mild-to-moderate UC at the time of screening (2 ≤ partial Mayo scores ≤ 5)
* Supportive evidence of active inflammation (hsCRP \>1 mg/L, fecal calprotectin \>50 µg/g stool, or abnormal lower endoscopy) in individuals with biopsy-proven UC
* Patients on 5-aminosalicylates must be on a stable dose for ≥ 4 weeks prior to screening
* Patients on treatment with immunosuppressive therapy (e.g., azathioprine/6-mercaptopurine, methotrexate) must be on stable dose for 8 weeks prior to baseline visit
* At the time of baseline visit, patients may be on no more than 20 mg/day of prednisone and 9 mg/day of budesonide MMX
* Subjects must read and sign the Institutional Review Board-approved written informed consent prior to the initiation of any study specific procedures or enrollment. A subject will be excluded for any condition that might compromise the ability to give truly informed consent.
Exclusion Criteria:
* • Non-English speaker
* Vegetarian/vegan
* Known pomegranate allergy
* Documented chronic disease besides UC, including diabetes, renal or liver diseases, metabolic syndrome, active cancer, MI or stroke, history of gastric bypass
* Patients with CD, indeterminate/severe to fulminant colitis
* History of colectomy or colonic dysplasia
* Presence of ileal pouch or ostomy
* Evidence of active bacterial or viral gastroenteritis as indicated by positive stool studies for ova \& parasites, Clostridium difficile, and stool culture
* Recent hospitalizations (within 2 weeks of screening) for UC requiring IV steroids
* Presence of the following labs indicative of severe colitis: a. Hemoglobin \< 8.0 g/dl b. Albumin \< 3.0 g/dl
* Recent systemic antibiotics use (within 3 months of screening) or active use of anti-diarrheal medications
* Taking supplements known to affect metabolism or gut microbiota composition (probiotics, fiber, etc.), unless willing to stop for the study duration
* Use of Total Parenteral Nutrition (TPN)
* Use of cyclosporine, tacrolimus, or thalidomide within 2 months prior to screening
* Taking exogenous hormones (e.g., hormone replacement therapy)
* Recent weight fluctuations (\>10% in the last 6 months)
* Smoker or living with a smoker
* Use of \>20 g of alcohol per day
* Unable or unwilling to comply with the study protocol (including unwillingness to avoid watermelon and other lycopene-rich foods for the whole duration of the study)
* Unable to provide consent
Study design
Enrollment target: 30 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-10-15
Estimated completion: 2027-10-15
Last updated: 2025-12-09
Interventions
Other: pomegranate juice -> habitual dietOther: habitual diet -> pomegranate juice
Primary outcomes
- • simple clinical colitis activity index (SCCAI) (At baseline, 8 weeks and 16 weeks)
- • Fecal calprotectin (At baseline, 8 weeks and 16 weeks)
Sponsor
University of California, Los Angeles · other
With: National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contacts & investigators
ContactTatiana Diacova, PhD, MS, RDN · contact · tdiacova@mednet.ucla.edu · 310-206-8292
InvestigatorZhaoping Li, MD, PhD · principal_investigator, University of California, Los Angeles
All locations (2)
West Los Angeles VA Medical CenterNot Yet Recruiting
Los Angeles, California, United States
UCLA Center for Human NutritionRecruiting
Los Angeles, California, United States