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Pomegranate Extract Supplementation in Colorectal Cancer Patients

NCT01916239 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-04-14

No results posted yet for this study

Summary

The most relevant pomegranate phenolics (ellagitannins and ellagic acid) are extensively metabolized by the human gut microbiota to yield a number of metabolites called urolithins (mainly Uro-A). Urolithins have been reported to regulate in vivo the expression of genes involved in inflammation and cancer. Our hypothesis is that urolithins can be detected in the human colon mucosa where these metabolites can exert anti-inflammatory and anti-cancer activities. After colonoscopy and diagnosis, colorectal cancer patients will consume capsules containing three different pomegranate extract formulations until surgery. The aims of this trial are:

* To evaluate the disposition of pomegranate phenolics and urolithins in tumoral and normal colon tissues.
* To evaluate gene expression profiling and protein markers in tumoral and normal colon tissues from these patients.
* To compare different pomegranate extract formulations on the above.

Conditions

Interventions

DIETARY_SUPPLEMENT

Standard pomegranate extract formulation

Standard pomegranate extract formulation containing 20% punicalagin

DIETARY_SUPPLEMENT

Pomegranate extract formulation-1

New pomegranate extract formulation-1

DIETARY_SUPPLEMENT

Pomegranate extract formulation-2

New pomegranate extract formulation-2

Sponsors & Collaborators

  • Hospital Universitario Reina Sofia de Cordoba

    collaborator OTHER_GOV

  • National Research Council, Spain

    lead OTHER_GOV

Principal Investigators

  • Dr. Juan Carlos Espín, PhD · National Research Council (CEBAS-CSIC, Murcia, Spain)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2015-02-28
Completion
2015-04-30

Countries

  • Spain

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 NCT01916239 on ClinicalTrials.gov