Spots Global Cancer Trial Database for Pomegranate Extract Supplementation in Colorectal Cancer Patients

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Trial Identification

Brief Title: Pomegranate Extract Supplementation in Colorectal Cancer Patients

Official Title: Phase I-II Study of Pomegranate Extract Formulations in Colorectal Cancer Patients: Metabolic and Gene Expression Profiling in Tumoral and Normal Colon Tissues

Study ID: NCT01916239

Conditions

Colorectal Cancer

Interventions

Standard pomegranate extract formulation

Pomegranate extract formulation-1

Pomegranate extract formulation-2

Study Description

Brief 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.

Detailed Description: