Ulcerative Colitis (Disorder)NCT07115862
Effects of Pomegranate Juice on Ulcerative Colitis
A study testing pomegranate juice -> habitual diet and habitual diet -> pomegranate juice in people with Ulcerative Colitis (Disorder), run by University of California, Los Angeles at 2 sites in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis (Disorder)
- What is being tested?
- pomegranate juice -> habitual diet and habitual diet -> pomegranate juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Oct 2025to 15 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- • 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
Show all 20Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
West Los Angeles VA Medical Center
Los Angeles, California, 90073
Tatiana Diacova, PhD, MS, RD, 310-206-8292, tdiacova@mednet.ucla.edu
Zhaoping Li, MD, PhD
- Recruiting
UCLA Center for Human Nutrition
Los Angeles, California, 90095
Tatiana Diacova, PhD, MS, RD, 310-206-8292, tdiacova@mednet.ucla.edu
Zhaoping Li, MD, PhD
About this study
Official title: 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:
- lower inflammation (in the gut as well as generally in the body) and improve your overall quality of life
- affect the microbes living in the gut (gut microbiota)
Read the 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).
- Conditions
- Ulcerative Colitis (Disorder)
- Being tested
- pomegranate juice -> habitual diet, habitual diet -> pomegranate juice
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pomegranate juice -> habitual dietOther
237 ml of pomegranate juice for the first 8 weeks -> habitual diet for the second 8 weeks
habitual diet -> pomegranate juiceOther
habitual diet for the first 8 weeks -> 237 ml of pomegranate juice for the second 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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 Receives: Other: pomegranate juice -> habitual diet |
| Delayed start | Experimental | 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 Receives: Other: habitual diet -> pomegranate juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At baseline, 8 weeks and 16 weeks
Secondary outcomes (10)
Biomarkers of inflammation and oxidative stress
Blood interleukin-6 (IL-6) in pg/ml
Measured: At baseline, week 8 and week 16
Biomarkers of inflammation and oxidative stress
Blood interleukin-10 (IL-10) in pg/ml
Measured: At baseline, week 8 and week 16
Biomarkers of aging and oxidative stress
Blood TNF-a in pg/ml
Measured: At baseline, week 8 and week 16
Biomarkers of inflammation and oxidative stress
Blood IL-1b in pg/ml
Measured: At baseline, week 8 and 16
Biomarkers of inflammation and oxidative stress
Blood IL-8 in pg/ml
Measured: At baseline, weeks 8 and 16
Biomarkers of inflammation and oxidative stress
Blood hs-CRP in mg/ml
Measured: At Baseline, weeks 8 and 16
Biomarkers of inflammation and oxidative stress
Urine malondialdehyde (MDA) in ng/ml
Measured: At baseline, weeks 8 and 16
Biomarkers of inflammation and oxidative stress
Blood MDA in nmol/ml
Measured: At baseline, weeks 8 and 16
Biomarkers of inflammation and oxidative stress
Urine 8OHdG in ng/mg
Measured: At baseline, weeks 8 and 16
Biomarkers of inflammation and oxidative stress
Blood 8OHdG in ng/ml
Measured: At baseline, weeks 8 and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start15 Oct 2025
- Primary completion15 Oct 2027 (estimated)
- Study completion15 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (Disorder)Studies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Zhaoping Li, University of California, Los Angeles
- Investigators
- Zhaoping Li, MD, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115862
- Sponsor's protocol ID
- IRB-25-1553
- Other IDs
- T32DK007180
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data analysis will be performed in-house.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pomegranate Juice on Gut Inflammation, Quality of Life and the Gut Microbiome in Patients With Ulcerative Colitis: A Pilot Study
- ClinicalTrials.gov ID
- NCT07115862
- Acronym / sponsor ID
- IRB-25-1553
- Conditions
- Ulcerative Colitis (Disorder)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 15 Oct 2027 (estimated)
- Study completion
- 15 Oct 2027 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether consumption of 237 ml of pomegranate juice daily for 8 weeks will:
- lower inflammation (in the gut as well as generally in the body) and improve your overall quality of life
- 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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: pomegranate juice -> habitual dietParticipants 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 |
| Delayed start | Experimental | Other: habitual diet -> pomegranate juiceParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- • Adults ≥ 18 yo
Key exclusion criteria (20 listed)
- • Non-English speaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pomegranate juice -> habitual diet237 ml of pomegranate juice for the first 8 weeks -> habitual diet for the second 8 weeks | Other | Intervention |
| habitual diet -> pomegranate juicehabitual diet for the first 8 weeks -> 237 ml of pomegranate juice for the second 8 weeks | Other | Delayed start |
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.
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.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: No. Data analysis will be performed in-house.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhaoping Li, MD, PhD principal investigator
University of California, Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pomegranate juice -> habitual diet and habitual diet -> pomegranate juice in people with Ulcerative Colitis (Disorder), run by University of California, Los Angeles at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tatiana Diacova, PhD, MS, RDN (310-206-8292, tdiacova@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
simple clinical colitis activity index (SCCAI) (time frame: At baseline, 8 weeks and 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.