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

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)

Study Overview

• Status: Recruiting
• Conditions: Ulcerative Colitis (Disorder)
• Intervention / Treatment: Other: pomegranate juice -> habitual diet; Other: habitual diet -> pomegranate juice

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).

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tatiana Diacova, PhD, MS, RDN; Phone Number: 310-206-8292; Email: tdiacova@mednet.ucla.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90073
      • Not yet recruiting
      • West Los Angeles VA Medical Center
      • Principal Investigator: Zhaoping Li, MD, PhD
      • Contact: Tatiana Diacova, PhD, MS, RD; Phone Number: 310-206-8292; Email: tdiacova@mednet.ucla.edu
    • Los Angeles, California, United States, 90095
      • Recruiting
      • UCLA Center for Human Nutrition
      • Principal Investigator: Zhaoping Li, MD, PhD
      • Contact: Tatiana Diacova, PhD, MS, RD; Phone Number: 310-206-8292; Email: tdiacova@mednet.ucla.edu
      • Sub-Investigator: Berkeley Limketkai, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; 237 ml of pomegranate juice for the first 8 weeks -> habitual diet for the second 8 weeks
Experimental: Delayed start; 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; habitual diet for the first 8 weeks -> 237 ml of pomegranate juice for the second 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarkers of inflammation and oxidative stress	Blood interleukin-6 (IL-6) in pg/ml	At baseline, week 8 and week 16
Biomarkers of inflammation and oxidative stress	Blood interleukin-10 (IL-10) in pg/ml	At baseline, week 8 and week 16
Biomarkers of aging and oxidative stress	Blood TNF-a in pg/ml	At baseline, week 8 and week 16
Biomarkers of inflammation and oxidative stress	Blood IL-1b in pg/ml	At baseline, week 8 and 16
Biomarkers of inflammation and oxidative stress	Blood IL-8 in pg/ml	At baseline, weeks 8 and 16
Biomarkers of inflammation and oxidative stress	Blood hs-CRP in mg/ml	At Baseline, weeks 8 and 16
Biomarkers of inflammation and oxidative stress	Urine malondialdehyde (MDA) in ng/ml	At baseline, weeks 8 and 16
Biomarkers of inflammation and oxidative stress	Blood MDA in nmol/ml	At baseline, weeks 8 and 16
Biomarkers of inflammation and oxidative stress	Urine 8OHdG in ng/mg	At baseline, weeks 8 and 16
Biomarkers of inflammation and oxidative stress	Blood 8OHdG in ng/ml	At baseline, weeks 8 and 16

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut-derived metabolites	Blood urolithin metabolites in micromoles/L	At baseline, weeks 8 and 16
Gut-derived metabolites	Urine urolithin metabolites	At baseline, weeks 8 and 16
Microbial inflammatory components	Blood lipopolysaccharide in ng/ml	At baseline, weeks 8 and 16
Microbial inflammatory components	Blood LPS binding protein in micrograms/ml	At baseline, weeks 8 and 16
Microbial-derived metabolites	Fecal short-chain fatty acids (SCFAs) in micromoles/g	At baseline, weeks 8 and 16
Microbial-derived metabolites	Fecal bile acids (BAs) in ng/ml	At baseline, weeks 8 and 16
Gut microbiota composition	The stool specimen will be collected by the participants at home at baseline and week 12 utilizing our Stool Collection Kit as per instructions. Immediately after collection, the specimen will be frozen in a home freezer and delivered in an insulated container to the UCLA Center for Human Nutrition. At UCLA, the specimen will be stored at - 80 ºC. Fecal microbiological analyses. Approximately 1g of the stool will be weighed and dried in a vacuum drying oven (15 in Hg) at 80 ºC for 48 hours, then weighed again to establish the moisture content so that all counts can be corrected to dry weight. From another aliquot of remaining fecal samples, DNA will be extracted using bead beating with a commercial extraction system (DNeasy PowerSoil® DNA Isolation Kit, Qiagen, Valencia, CA). The quality of the DNA samples will be confirmed using a Nanodrop 1000 (Thermo Fisher Scientific, Wilmington, DE). Extracted DNA will be transferred to UCLA Microbiome Core facility for MiSeq sequencing.	At baseline, weeks 8 and 16

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Zhaoping Li, MD, PhD, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2025
• Primary Completion (Estimated): October 15, 2027
• Study Completion (Estimated): October 15, 2027

Study Registration Dates

• First Submitted: August 4, 2025
• First Submitted That Met QC Criteria: August 4, 2025
• First Posted (Actual): August 11, 2025

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: IRB-25-1553; T32DK007180 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data analysis will be performed in-house.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No