Ulcerative Colitis (Disorder)
Pomegranate Juice in Adults With Mild-to-Moderate Ulcerative Colitis
This pilot study is investigating how eight weeks of daily pomegranate juice affects inflammation, quality of life, and the gut microbiome in adults with mild-to-moderate ulcerative colitis.
Registry title: Effects of Pomegranate Juice on Ulcerative Colitis
2 recruiting U.S. sites ↓Study at a glance
- Age
- 18 Years and older
- Treatment
- pomegranate juice -> habitual diet or habitual diet -> pomegranate juice
- Design
- Randomized
- Central study contact
- Tatiana Diacova, PhD, MS, RDN310-206-8292tdiacova@mednet.ucla.edu
- Sponsor
- University of California, Los Angeles
Research question
In adults with mild-to-moderate ulcerative colitis, how does drinking 237 milliliters of pomegranate juice daily for eight weeks affect gut and body-wide inflammation, quality of life, and gut microbiota?
Participant snapshot
Who the study is looking for
- The study is looking for adults age 18 or older with biopsy-proven ulcerative colitis.
- The study is looking for people with mild-to-moderate ulcerative colitis at screening, defined as a partial Mayo score from 2 through 5.
- The study is looking for people with evidence of active inflammation based on high-sensitivity C-reactive protein, fecal calprotectin, or an abnormal lower endoscopy.
- The study is looking for people who follow a low-polyphenol and low-fiber diet with fewer than three servings of fruits and vegetables per day.
- The registry lists one recruiting UCLA location in Los Angeles, California.
Participation overview
What participation may involve
Participation lasts 16 weeks and includes two eight-week phases. Depending on random assignment, participants drink pomegranate juice during either the first or second phase and follow their habitual diet during the other phase. What participation may involve: - Drink 237 milliliters of pomegranate juice daily for one eight-week phase. - Follow the habitual diet without pomegranate juice during the other eight-week phase. - Complete assessments of ulcerative colitis symptoms, including bowel frequency and urgency. - Provide stool, blood, and urine samples for measurements of inflammation, oxidative stress, gut-derived metabolites, and gut microbiota. - Collect specified stool specimens at home, freeze them, and deliver them in an insulated container to the UCLA Center for Human Nutrition. The reported study duration is 16 weeks, divided into two phases of eight weeks each.
Study interventions
What participants may receive or do
- pomegranate juice -> habitual diet: Participants assigned to this sequence drink 237 milliliters of pomegranate juice daily for the first eight weeks, then stop the juice and follow their habitual diet for the second eight weeks.
- habitual diet -> pomegranate juice: Participants assigned to this delayed-start sequence follow their habitual diet for the first eight weeks, then drink 237 milliliters of pomegranate juice daily for the second eight weeks.
Study design
How the comparison works
This is a randomized, open-label, 16-week pilot study with two eight-week phases. Both groups receive pomegranate juice, but they start it at different times. Participants are randomly assigned either to drink pomegranate juice during the first eight weeks or to begin it during the second eight weeks. The study has no masking, meaning the registry does not describe participants or researchers as blinded to the assigned sequence. During the first eight weeks, data from the delayed-start group following its habitual diet serve as the study control.
Reported activities
Procedures and tests
- The Simple Clinical Colitis Activity Index questionnaire measures symptoms such as bowel frequency and urgency at baseline, week 8, and week 16.
- Stool samples are tested for fecal calprotectin, a measure of gut inflammation, at baseline, week 8, and week 16.
- Blood samples are used to measure inflammatory markers including interleukins, tumor necrosis factor alpha, and high-sensitivity C-reactive protein at baseline, week 8, and week 16.
- Blood and urine samples are used to measure markers of oxidative stress at baseline, week 8, and week 16.
- Blood and urine samples are used to measure urolithin metabolites.
- Blood samples are used to measure lipopolysaccharide and lipopolysaccharide-binding protein.
- Stool samples are used to measure short-chain fatty acids, bile acids, and gut microbiota composition.
- Specified stool specimens are collected at home, frozen in a home freezer, and delivered to UCLA for processing and microbiome sequencing.
- Screening may involve confirming active inflammation through high-sensitivity C-reactive protein, fecal calprotectin, or prior lower-endoscopy findings.
- Screening may involve reviewing stool-study results for ova and parasites, Clostridium difficile, and bacterial culture because active gastroenteritis is excluded.
- Screening may involve checking hemoglobin and albumin because values below the listed thresholds are exclusion criteria.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must be adults age 18 or older.
- Participants must follow a low-polyphenol and low-fiber diet, defined as fewer than three servings of fruits and vegetables per day.
- Ulcerative colitis must be mild to moderate at screening, with a partial Mayo score from 2 through 5.
- Biopsy-proven ulcerative colitis must have active inflammation supported by high-sensitivity C-reactive protein above 1 mg/L, fecal calprotectin above 50 µg/g, or an abnormal lower endoscopy.
- Participants taking 5-aminosalicylates must have used a stable dose for at least four weeks before screening.
- Participants using immunosuppressive therapy such as azathioprine, 6-mercaptopurine, or methotrexate must have used a stable dose for eight weeks before the baseline visit.
- At the baseline visit, prednisone use may not exceed 20 mg per day and budesonide MMX use may not exceed 9 mg per day.
- Participants must read and sign the approved informed-consent form before study-specific procedures or enrollment and must be able to provide informed consent.
Possible reasons someone may not be able to join
- People who do not speak English are excluded.
- People following a vegetarian or vegan diet are excluded.
- People with a known pomegranate allergy are excluded.
- The registry excludes people with a documented chronic disease other than ulcerative colitis, including diabetes, kidney or liver disease, metabolic syndrome, active cancer, myocardial infarction or stroke, or a history of gastric bypass.
- People with Crohn's disease, indeterminate colitis, or severe-to-fulminant colitis are excluded.
- People with a history of colectomy or colonic dysplasia, or who have an ileal pouch or ostomy, are excluded.
- Active bacterial or viral gastroenteritis indicated by positive stool studies for ova and parasites, Clostridium difficile, or stool culture is exclusionary.
- Hospitalization for ulcerative colitis requiring intravenous steroids within two weeks before screening is exclusionary.
- Hemoglobin below 8.0 g/dL or albumin below 3.0 g/dL is exclusionary as laboratory evidence of severe colitis.
- Systemic antibiotic use within three months before screening or active use of anti-diarrheal medication is exclusionary.
- People taking supplements that may affect metabolism or gut microbiota, such as probiotics or fiber, must be willing to stop them for the study duration.
- Participants must be willing to follow the protocol, including avoiding watermelon and other lycopene-rich foods throughout the study.
Important unknowns
What the record does not make clear
- The record reports assessment time points but does not state the number, format, or length of study visits.
- The eligibility criteria give stability requirements and dose limits for some ulcerative colitis medicines but do not clearly state which treatments must remain unchanged throughout the study.
- The record requires recent avoidance of several medicines and willingness to stop certain supplements, but it does not report when supplements must be stopped.
- The record does not explain how worsening ulcerative colitis or a flare would be managed during the study.
- An abnormal lower endoscopy can support active inflammation for eligibility, but the record does not say whether a new endoscopy is required.
- The record does not state which study-related or routine-care costs are covered or billed to insurance.
- The record does not report whether participants receive compensation.
- The record does not state whether transportation, parking, lodging, or other travel expenses are reimbursed.
- The record does not state whether any visits or activities can be completed remotely.
- The study is listed as recruiting overall, but the West Los Angeles VA Medical Center is not yet recruiting while the UCLA Center for Human Nutrition is recruiting.
- The gut-microbiota outcome description says stool is collected at baseline and week 12, while its reported timeframe says baseline, week 8, and week 16.
Before contacting the site
Questions for the study team
- How many study visits are required, where do they occur, and how long does each one take?
- At which weeks are stool, blood, and urine samples collected, especially given the differing stool-collection statements?
- Which ulcerative colitis medicines can continue, and must doses remain stable during the full study?
- Which supplements must be stopped, and when must they be stopped before baseline?
- What happens if ulcerative colitis symptoms worsen or rescue treatment becomes necessary?
- Is a new lower endoscopy required, or can prior results be used to document active inflammation?
- Which costs are covered, is compensation offered, and is parking or travel reimbursed?
- Is the UCLA Center for Human Nutrition the only site currently enrolling, and can any study activities be completed remotely?
Before changing care
Questions for your gastroenterologist
- Would keeping my current ulcerative colitis treatment stable for this study be medically appropriate in my situation?
- How stable is my ulcerative colitis now, and how should a flare or worsening symptoms be handled while the research team is involved?
- What approved treatment alternatives should I understand before considering this research study?
- Do the required diet changes or stopping probiotics, fiber, or other supplements raise concerns for my nutritional status or disease management?
- How should you and the research team coordinate medication decisions, laboratory results, and care if my symptoms change?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this 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)
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 design and administration
- Organization
- University of California, Los Angeles
- Organization class
- Other
- Organization study ID
- IRB-25-1553
- Lead sponsor
- University of California, Los Angeles
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Crossover
- Primary purpose
- Supportive Care
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Adult, Older Adult
Study 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
Interventions: Other: pomegranate juice -> habitual diet
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: Other: habitual diet -> pomegranate juice
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
Eligibility
18 Years and older
All
Not accepted
Inclusion criteria (8)
- • Adults ≥ 18 yoRegistry-derived · unreviewed
- Following a low-polyphenol and fiber diet (\< 3 servings of fruits/vegetables per day)Registry-derived · unreviewed
- Mild-to-moderate UC at the time of screening (2 ≤ partial Mayo scores ≤ 5)Registry-derived · unreviewed
- Supportive evidence of active inflammation (hsCRP \>1 mg/L, fecal calprotectin \>50 µg/g stool, or abnormal lower endoscopy) in individuals with biopsy-proven UCRegistry-derived · unreviewed
- Patients on 5-aminosalicylates must be on a stable dose for ≥ 4 weeks prior to screeningRegistry-derived · unreviewed
- Patients on treatment with immunosuppressive therapy (e.g., azathioprine/6-mercaptopurine, methotrexate) must be on stable dose for 8 weeks prior to baseline visitRegistry-derived · unreviewed
- At the time of baseline visit, patients may be on no more than 20 mg/day of prednisone and 9 mg/day of budesonide MMXRegistry-derived · unreviewed
- 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.Registry-derived · unreviewed
Exclusion criteria (20)
- • Non-English speakerRegistry-derived · unreviewed
- Vegetarian/veganRegistry-derived · unreviewed
- Known pomegranate allergyRegistry-derived · unreviewed
- Documented chronic disease besides UC, including diabetes, renal or liver diseases, metabolic syndrome, active cancer, MI or stroke, history of gastric bypassRegistry-derived · unreviewed
- Patients with CD, indeterminate/severe to fulminant colitisRegistry-derived · unreviewed
- History of colectomy or colonic dysplasiaRegistry-derived · unreviewed
- Presence of ileal pouch or ostomyRegistry-derived · unreviewed
- Evidence of active bacterial or viral gastroenteritis as indicated by positive stool studies for ova \& parasites, Clostridium difficile, and stool cultureRegistry-derived · unreviewed
- Recent hospitalizations (within 2 weeks of screening) for UC requiring IV steroidsRegistry-derived · unreviewed
- Presence of the following labs indicative of severe colitis: a. Hemoglobin \< 8.0 g/dl b. Albumin \< 3.0 g/dlRegistry-derived · unreviewed
- Recent systemic antibiotics use (within 3 months of screening) or active use of anti-diarrheal medicationsRegistry-derived · unreviewed
- Taking supplements known to affect metabolism or gut microbiota composition (probiotics, fiber, etc.), unless willing to stop for the study durationRegistry-derived · unreviewed
- Use of Total Parenteral Nutrition (TPN)Registry-derived · unreviewed
- Use of cyclosporine, tacrolimus, or thalidomide within 2 months prior to screeningRegistry-derived · unreviewed
- Taking exogenous hormones (e.g., hormone replacement therapy)Registry-derived · unreviewed
- Recent weight fluctuations (\>10% in the last 6 months)Registry-derived · unreviewed
- Smoker or living with a smokerRegistry-derived · unreviewed
- Use of \>20 g of alcohol per dayRegistry-derived · unreviewed
- 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)Registry-derived · unreviewed
- Unable to provide consentRegistry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
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.
Primary outcome
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.
Secondary outcome
Biomarkers of inflammation and oxidative stress
Time frame: At baseline, week 8 and week 16
Blood interleukin-6 (IL-6) in pg/ml
Secondary outcome
Biomarkers of inflammation and oxidative stress
Time frame: At baseline, week 8 and week 16
Blood interleukin-10 (IL-10) in pg/ml
Secondary outcome
Biomarkers of aging and oxidative stress
Time frame: At baseline, week 8 and week 16
Blood TNF-a in pg/ml
Secondary outcome
Biomarkers of inflammation and oxidative stress
Time frame: At baseline, week 8 and 16
Blood IL-1b in pg/ml
Secondary outcome
Biomarkers of inflammation and oxidative stress
Time frame: At baseline, weeks 8 and 16
Blood IL-8 in pg/ml
Secondary outcome
Biomarkers of inflammation and oxidative stress
Time frame: At Baseline, weeks 8 and 16
Blood hs-CRP in mg/ml
Secondary outcome
Biomarkers of inflammation and oxidative stress
Time frame: At baseline, weeks 8 and 16
Urine malondialdehyde (MDA) in ng/ml
Secondary outcome
Biomarkers of inflammation and oxidative stress
Time frame: At baseline, weeks 8 and 16
Blood MDA in nmol/ml
Secondary outcome
Biomarkers of inflammation and oxidative stress
Time frame: At baseline, weeks 8 and 16
Urine 8OHdG in ng/mg
Secondary outcome
Biomarkers of inflammation and oxidative stress
Time frame: At baseline, weeks 8 and 16
Blood 8OHdG in ng/ml
Recruiting locations in the United States
UCLA Center for Human Nutrition
RecruitingLos Angeles, California, 90095, United States
Tatiana Diacova, PhD, MS, RD310-206-8292tdiacova@mednet.ucla.edu
Zhaoping Li, MD, PhD
Berkeley Limketkai, MD, PhD
West Los Angeles VA Medical Center
Not Yet RecruitingLos Angeles, California, 90073, United States
Tatiana Diacova, PhD, MS, RD310-206-8292tdiacova@mednet.ucla.edu
Zhaoping Li, MD, PhD
Central study contacts
Registry dates
- First posted
- Aug 11, 2025
- Primary completion
- Oct 15, 2027
- Overall completion
- Oct 15, 2027
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.