Effects of Pomegranate Juice on Ulcerative Colitis

Official title

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

Overview

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).

Interventions

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

Primary outcome measures

• simple clinical colitis activity index (SCCAI) [Time frame: At baseline, 8 weeks and 16 weeks]
• Fecal calprotectin [Time frame: At baseline, 8 weeks and 16 weeks]

Secondary outcome measures (10)

• Biomarkers of inflammation and oxidative stress [Time frame: At baseline, week 8 and week 16]
• Biomarkers of inflammation and oxidative stress [Time frame: At baseline, week 8 and week 16]
• Biomarkers of aging and oxidative stress [Time frame: At baseline, week 8 and week 16]
• Biomarkers of inflammation and oxidative stress [Time frame: At baseline, week 8 and 16]
• Biomarkers of inflammation and oxidative stress [Time frame: At baseline, weeks 8 and 16]
• Biomarkers of inflammation and oxidative stress [Time frame: At Baseline, weeks 8 and 16]
• Biomarkers of inflammation and oxidative stress [Time frame: At baseline, weeks 8 and 16]
• Biomarkers of inflammation and oxidative stress [Time frame: At baseline, weeks 8 and 16]
• Biomarkers of inflammation and oxidative stress [Time frame: At baseline, weeks 8 and 16]
• Biomarkers of inflammation and oxidative stress [Time frame: At baseline, weeks 8 and 16]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 2 centers

• West Los Angeles VA Medical Center — Los Angeles
• UCLA Center for Human Nutrition — Los Angeles

Identifiers

NCT: NCT07115862 · IRB-25-1553 · T32DK007180

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗