Recruiting

Pomegranate Juice

Sponsor:

UCLA

Code:

NCT07115862

Conditions

Ulcerative Colitis (Disorder)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

pomegranate juice -> habitual diet

habitual diet -> pomegranate juice

Study Details

Brief 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)

Conditions

Ulcerative Colitis (Disorder)

Study ID

NCT07115862

Start date

Oct 15, 2025

Status verified date

Aug, 2025

Completion date

Oct 15, 2027

Anticipated

Primary completion date

Oct 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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

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

Interventions

pomegranate juice -> habitual diet

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

habitual diet -> pomegranate juice

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Tatiana Diacova, PhD, MS, RDN

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

Locations

UCLA Center for Human Nutrition

Recruiting

Los Angeles, California, United States, 90095

Contacts

Tatiana Diacova, PhD, MS, RD

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

Principal Investigator:

Zhaoping Li, MD, PhD

More Information

Sponsor

University of California, Los Angeles

Last update posted

Dec 9, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2025-12-09.