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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
30
237 ml of pomegranate juice for the first 8 weeks -\> habitual diet for the second 8 weeks
habitual diet for the first 8 weeks -\> 237 ml of pomegranate juice for the second 8 weeks
West Los Angeles VA Medical Center
Los Angeles, California, United States
NOT_YET_RECRUITINGUCLA Center for Human Nutrition
Los Angeles, California, United States
RECRUITINGsimple 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
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
Biomarkers of inflammation and oxidative stress
Blood IL-8 in pg/ml
Time frame: At baseline, weeks 8 and 16
Biomarkers of inflammation and oxidative stress
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Blood hs-CRP in mg/ml
Time frame: At Baseline, weeks 8 and 16
Biomarkers of inflammation and oxidative stress
Urine malondialdehyde (MDA) in ng/ml
Time frame: At baseline, weeks 8 and 16
Biomarkers of inflammation and oxidative stress
Blood MDA in nmol/ml
Time frame: At baseline, weeks 8 and 16
Biomarkers of inflammation and oxidative stress
Urine 8OHdG in ng/mg
Time frame: At baseline, weeks 8 and 16
Biomarkers of inflammation and oxidative stress
Blood 8OHdG in ng/ml
Time frame: At baseline, weeks 8 and 16