NCT07115862 · University of California, Los Angeles
Effects of Pomegranate Juice on Ulcerative Colitis
What this study is about
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.
View original scientific description
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.
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
Simple Clinical Colitis Activity Index (SCCAI) includes questions about bowel frequency, urgency of defecation, etc. Measured by the number of points/scores.
Fecal calprotectin
Time frame: At baseline, 8 weeks and 16 weeks
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Los Angeles, California
Collaborators
National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 9, 2025 · Source of record for eligibility and locations