Effects of Pomegranate Juice on Ulcerative Colitis

Last updated: December 8, 2025
Sponsor: University of California, Los Angeles
Overall Status: Active - Recruiting

Phase

N/A

Condition

Inflammatory Bowel Disease

Crohn's Disease

Treatment

habitual diet -> pomegranate juice

pomegranate juice -> habitual diet

Clinical Study ID

NCT07115862
IRB-25-1553
T32DK007180
  • Ages > 18
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • • Adults ≥ 18 yo

  • Following a low-polyphenol and fiber diet (< 3 servings of fruits/vegetablesper 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-provenUC

  • Patients on 5-aminosalicylates must be on a stable dose for ≥ 4 weeks prior toscreening

  • Patients on treatment with immunosuppressive therapy (e.g.,azathioprine/6-mercaptopurine, methotrexate) must be on stable dose for 8 weeksprior to baseline visit

  • At the time of baseline visit, patients may be on no more than 20 mg/day ofprednisone and 9 mg/day of budesonide MMX

  • Subjects must read and sign the Institutional Review Board-approved writteninformed consent prior to the initiation of any study specific procedures orenrollment. A subject will be excluded for any condition that might compromisethe ability to give truly informed consent.

Exclusion

Exclusion Criteria:

  • • Non-English speaker

  • Vegetarian/vegan

  • Known pomegranate allergy

  • Documented chronic disease besides UC, including diabetes, renal or liverdiseases, metabolic syndrome, active cancer, MI or stroke, history of gastricbypass

  • 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 positivestool studies for ova & parasites, Clostridium difficile, and stool culture

  • Recent hospitalizations (within 2 weeks of screening) for UC requiring IVsteroids

  • 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 ofanti-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 toscreening

  • 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 unwillingnessto avoid watermelon and other lycopene-rich foods for the whole duration of thestudy)

  • Unable to provide consent

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: habitual diet -> pomegranate juice
Phase:
Study Start date:
October 15, 2025
Estimated Completion Date:
October 15, 2027

Study 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).

Connect with a study center

  • UCLA Center for Human Nutrition

    Los Angeles, California 90095
    United States

    Site Not Available

  • West Los Angeles VA Medical Center

    Los Angeles, California 90073
    United States

    Site Not Available

  • UCLA Center for Human Nutrition

    Los Angeles 5368361, California 5332921 90095
    United States

    Active - Recruiting

  • West Los Angeles VA Medical Center

    Los Angeles 5368361, California 5332921 90073
    United States

    Site Not Available

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