Study of the Role of Pomegranate Juice Ellagitannins in the Modulation of Inflammation in Inflammatory Bowel Diseases (POME2016)
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|ClinicalTrials.gov Identifier: NCT03000101|
Recruitment Status : Recruiting
First Posted : December 21, 2016
Last Update Posted : June 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease Ulcerative Colitis||Other: 100% pomegranate juice Other: placebo beverage||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||New Insight and Knowledge on Anti-inflammatory Effectiveness of Dietary Phenolics (NIKE)|
|Actual Study Start Date :||January 19, 2017|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Pomegranate juice
The pomegranate juice is 100% pomegranate juice, not from concentrate.
Other: 100% pomegranate juice
125 mL of 100% pomegranate juice twice daily for 12 weeks
Placebo Comparator: Placebo beverage
The placebo beverage consists in water added with sugar and citric acid.
Other: placebo beverage
125 mL of placebo beverage twice daily for 12 weeks
- Changes in fecal calprotectin [ Time Frame: Baseline and 12 weeks ]Change from baseline in fecal neutrophil-derived protein calprotectin, surrogate marker of mucosal improvement, after 12 weeks of consumption of experimental or placebo beverage, in subjects affected by IBD in clinical remission.
- Changes in plasma concentration of ellagitannin metabolites [ Time Frame: Baseline and 12 weeks ]Change from baseline in plasma concentration of ellagitannin metabolites after 12 weeks of intervention.
- Changes in circulating cytokines levels [ Time Frame: Baseline and 12 weeks ]Change from baseline in plasma levels of cytokines after 12 weeks of intervention.
- Changes in circulating trimethylamine-N-oxide (TMAO) levels [ Time Frame: Baseline and 12 weeks ]Change from baseline in plasma levels of TMAO after 12 weeks of intervention.
- Changes in gene expression levels in peripheral blood mononuclear cells (PBMC) [ Time Frame: Baseline and 12 weeks ]Change from baseline in expression levels of selected genes in PBMC by qPCR after 12 weeks of intervention.
- Changes in gene expression levels in intestinal biopsies [ Time Frame: Baseline and 12 weeks ]Change from baseline in expression levels of selected genes in intestinal biopsies by qPCR after 12 weeks of intervention.
- Changes in urinary ellagitannin metabolite excretion [ Time Frame: Baseline and 12 weeks ]Change from baseline in urinary ellagitannin metabolite excretion after 12 weeks of intervention.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03000101
|Contact: Andrea Belluzzi, MD PhDfirstname.lastname@example.org|
|U.O. Gastroenterologia - Azienda Ospedaliero-Universitaria di Bologna, Policlinico Sant'Orsola-Malpighi||Recruiting|
|Bologna, Italy, 40138|
|Contact: Eleonora Scaioli, MD PhD +390512143873 email@example.com|
|Study Director:||Francesca Danesi, PhD||Department of Agri-Food Sciences and Technologies, University of Bologna|
|Principal Investigator:||Luigi Ricciardiello, MD, Prof||Department of Medical and Surgical Sciences, University of Bologna|