Effects of Pomegranate Juice on Ulcerative Colitis

ConditionUlcerative Colitis (Disorder)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of California, Los Angeles

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• 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

Disqualifiers

• 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

Trial design

Design model

Crossover

Treatments tested in this trial

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

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: InterventionExperimental treatment 1 intervention

Group B: Delayed startExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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.

Time frame

At baseline, 8 weeks and 16 weeks

Secondary outcomes

Biomarkers of inflammation and oxidative stress

Blood interleukin-6 (IL-6) in pg/ml

Time frame

At baseline, week 8 and week 16

Biomarkers of inflammation and oxidative stress

Blood interleukin-10 (IL-10) in pg/ml

Time frame

At baseline, week 8 and week 16

Biomarkers of aging and oxidative stress

Blood TNF-a in pg/ml

Time frame

At baseline, week 8 and week 16

Biomarkers of inflammation and oxidative stress

Blood IL-1b in pg/ml

Time frame

At baseline, week 8 and 16

Other outcomes

Gut-derived metabolites

Blood urolithin metabolites in micromoles/L

Time frame

At baseline, weeks 8 and 16

Gut-derived metabolites

Urine urolithin metabolites

Time frame

At baseline, weeks 8 and 16

Microbial inflammatory components

Blood lipopolysaccharide in ng/ml

Time frame

At baseline, weeks 8 and 16

Microbial inflammatory components

Blood LPS binding protein in micrograms/ml

Time frame

At baseline, weeks 8 and 16

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Los Angeles

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov

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