NCT03000101

Study of the Role of Pomegranate Juice Ellagitannins in the Modulation of Inflammation in Inflammatory Bowel Disease

New Insight and Knowledge on Anti-inflammatory Effectiveness of Dietary Phenolics (NIKE)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The aim of this research is to study the effects of a pomegranate juice on calprotectin levels in patients suffering of inflammatory bowel disease (IBD) in clinical remission. Fecal calprotectin levels, surrogate marker of mucosal inflammation, will be measured from baseline to 12 weeks later (end of intervention). Systemic and mucosal changes of biochemical and molecular inflammatory response markers will be also assessed.

Detailed 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 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.

Conditions

• Crohn's Disease
• Ulcerative Colitis

Interventions

Type	Name	Description
OTHER	100% pomegranate juice	125 mL of 100% pomegranate juice twice daily for 12 weeks
OTHER	placebo beverage	125 mL of placebo beverage twice daily for 12 weeks

Timeline

• Start date: 2017-01-19
• Primary completion: 2023-07-19
• Completion: 2023-12-29
• First posted: 2016-12-21
• Last updated: 2023-08-30

Locations

1 site across 1 country: Italy