Study of the Role of Pomegranate Juice Ellagitannins in the Modulation of Inflammation in Inflammatory Bowel Disease
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 36
Summary
- Conditions
- Crohn's Disease
- Ulcerative Colitis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Basic Science
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
Description
The main purpose of the intervention trial is to assess the possible effect of pomegranate juice consumption on reducing fecal calprotectin (FC) levels in volunteers suffering from IBD with a high risk of clinical relapse. In detail, the objectives of this intervention are as follows: (i) assessing ...
The main purpose of the intervention trial is to assess the possible effect of pomegranate juice consumption on reducing fecal calprotectin (FC) levels in volunteers suffering from IBD with a high risk of clinical relapse. In detail, the objectives of this intervention are as follows: (i) assessing the changes in FC levels in the two groups (active treatment, control) from baseline to 12 weeks later (primary outcome); (ii) investigating the systemic and mucosal modifications of selected biochemical and molecular inflammatory response markers in the two groups after 12 weeks of the intervention compared with baseline (secondary outcomes); (iii) evaluating circulating and urinary ellagitannin-derived metabolites from regular pomegranate juice consumption in the two groups before and after the intervention. The detailed study protocol is published in the Trials journal.
Tracking Information
- NCT #
- NCT03000101
- Collaborators
- University of Bologna
- Conserve Italia
- GAT Foods
- Investigators
- 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
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