Effects of Pomegranate Juice on Ulcerative Colitis

NCT07115862 | Recruiting

• 2 other identifiers: IRB-25-1553T32DK007180
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine whether consumption of 237 ml of pomegranate juice daily for 8 weeks will:

1. 1.lower inflammation (in the gut as well as generally in the body) and improve your overall quality of life
2. 2.affect the microbes living in the gut (gut microbiota)

Conditions

Ulcerative Colitis (Disorder)

Outcome Measures

Primary Outcomes (2)

• simple clinical colitis activity index (SCCAI)

  Simple Clinical Colitis Activity Index (SCCAI) includes questions about bowel frequency, urgency of defecation, etc. Measured by the number of points/scores.

  At baseline, 8 weeks and 16 weeks

• Fecal calprotectin

  To evaluate effects of PomJ on gut inflammation in patients with mild-to-moderate UC. The primary outcome will be levels of fecal calprotectin (objective measure). Fecal calprotectin levels will be assessed via a commercially available ELISA kit in mcg/g.

  At baseline, 8 weeks and 16 weeks

Secondary Outcomes (10)

• Biomarkers of inflammation and oxidative stress

  At baseline, week 8 and week 16

• Biomarkers of inflammation and oxidative stress

  At baseline, week 8 and week 16

• Biomarkers of aging and oxidative stress

  At baseline, week 8 and week 16

• Biomarkers of inflammation and oxidative stress

  At baseline, week 8 and 16

• Biomarkers of inflammation and oxidative stress

  At baseline, weeks 8 and 16

Other Outcomes (7)

• Gut-derived metabolites

  At baseline, weeks 8 and 16

• Gut-derived metabolites

  At baseline, weeks 8 and 16

• Microbial inflammatory components

  At baseline, weeks 8 and 16

Study Arms (2)

Intervention

EXPERIMENTAL

Participants in this arm will be consuming 237 ml of pomegranate juice for the first 8 weeks of the study and their habitual diet without pomegranate juice for the second 8 weeks

Other: pomegranate juice -> habitual diet

Delayed start

EXPERIMENTAL

Participants in this arm will consume their habitual diet for the first 8 weeks of the study and drink 237 ml of pomegranate juice for the second 8 weeks

Other: habitual diet -> pomegranate juice

Interventions

habitual diet -> pomegranate juice OTHER

habitual diet for the first 8 weeks -\> 237 ml of pomegranate juice for the second 8 weeks

Delayed start

pomegranate juice -> habitual diet OTHER

237 ml of pomegranate juice for the first 8 weeks -\> habitual diet for the second 8 weeks

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

West Los Angeles VA Medical Center

Los Angeles, California, 90073, United States

NOT YET RECRUITING

UCLA Center for Human Nutrition

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Zhaoping Li, MD, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tatiana Diacova, PhD, MS, RDN

CONTACT

310-206-8292; tdiacova@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 11, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): October 15, 2027
• Study Completion (Estimated): October 15, 2027
• Last Updated: December 9, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)