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

NCT03000101 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-08-30

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • University of Bologna

    collaborator OTHER

  • Conserve Italia

    collaborator UNKNOWN

  • GAT Foods

    collaborator OTHER

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Principal Investigators

  • Francesca Danesi, PhD · Department of Agri-Food Sciences and Technologies, University of Bologna

  • Luigi Ricciardiello, MD, Prof · Department of Medical and Surgical Sciences, University of Bologna

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-19
Primary Completion
2023-07-19
Completion
2023-12-29

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03000101 on ClinicalTrials.gov