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| ID | Type | Description | Link |
|---|---|---|---|
| T32DK007180 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The purpose of this study is to determine whether consumption of 237 ml of pomegranate juice daily for 8 weeks will:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pomegranate juice -> habitual diet | Other | 237 ml of pomegranate juice for the first 8 weeks -> habitual diet for the second 8 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | At baseline, 8 weeks and 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers of inflammation and oxidative stress | Blood interleukin-6 (IL-6) in pg/ml | At baseline, week 8 and week 16 |
| Biomarkers of inflammation and oxidative stress | Blood interleukin-10 (IL-10) in pg/ml |
| Measure | Description | Time Frame |
|---|---|---|
| Gut-derived metabolites | Blood urolithin metabolites in micromoles/L | At baseline, weeks 8 and 16 |
| Gut-derived metabolites | Urine urolithin metabolites |
Inclusion Criteria:
• Adults ≥ 18 yo
Exclusion Criteria:
• Non-English speaker
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tatiana Diacova, PhD, MS, RDN | Contact | 310-206-8292 | tdiacova@mednet.ucla.edu |
| Name | Affiliation | Role |
|---|---|---|
| Zhaoping Li, MD, PhD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Los Angeles VA Medical Center | Not yet recruiting | Los Angeles | California | 90073 | United States |
Data analysis will be performed in-house.
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| habitual diet -> pomegranate juice | Other | habitual diet for the first 8 weeks -> 237 ml of pomegranate juice for the second 8 weeks |
|
| At baseline, week 8 and week 16 |
| Biomarkers of aging and oxidative stress | Blood TNF-a in pg/ml | At baseline, week 8 and week 16 |
| Biomarkers of inflammation and oxidative stress | Blood IL-1b in pg/ml | At baseline, week 8 and 16 |
| Biomarkers of inflammation and oxidative stress | Blood IL-8 in pg/ml | At baseline, weeks 8 and 16 |
| Biomarkers of inflammation and oxidative stress | Blood hs-CRP in mg/ml | At Baseline, weeks 8 and 16 |
| Biomarkers of inflammation and oxidative stress | Urine malondialdehyde (MDA) in ng/ml | At baseline, weeks 8 and 16 |
| Biomarkers of inflammation and oxidative stress | Blood MDA in nmol/ml | At baseline, weeks 8 and 16 |
| Biomarkers of inflammation and oxidative stress | Urine 8OHdG in ng/mg | At baseline, weeks 8 and 16 |
| Biomarkers of inflammation and oxidative stress | Blood 8OHdG in ng/ml | At baseline, weeks 8 and 16 |
| At baseline, weeks 8 and 16 |
| Microbial inflammatory components | Blood lipopolysaccharide in ng/ml | At baseline, weeks 8 and 16 |
| Microbial inflammatory components | Blood LPS binding protein in micrograms/ml | At baseline, weeks 8 and 16 |
| Microbial-derived metabolites | Fecal short-chain fatty acids (SCFAs) in micromoles/g | At baseline, weeks 8 and 16 |
| Microbial-derived metabolites | Fecal bile acids (BAs) in ng/ml | At baseline, weeks 8 and 16 |
| Gut microbiota composition | The stool specimen will be collected by the participants at home at baseline and week 12 utilizing our Stool Collection Kit as per instructions. Immediately after collection, the specimen will be frozen in a home freezer and delivered in an insulated container to the UCLA Center for Human Nutrition. At UCLA, the specimen will be stored at - 80 ºC. Fecal microbiological analyses. Approximately 1g of the stool will be weighed and dried in a vacuum drying oven (15 in Hg) at 80 ºC for 48 hours, then weighed again to establish the moisture content so that all counts can be corrected to dry weight. From another aliquot of remaining fecal samples, DNA will be extracted using bead beating with a commercial extraction system (DNeasy PowerSoil® DNA Isolation Kit, Qiagen, Valencia, CA). The quality of the DNA samples will be confirmed using a Nanodrop 1000 (Thermo Fisher Scientific, Wilmington, DE). Extracted DNA will be transferred to UCLA Microbiome Core facility for MiSeq sequencing. | At baseline, weeks 8 and 16 |
| UCLA Center for Human Nutrition | Recruiting | Los Angeles | California | 90095 | United States |
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| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |