Colorectal Cancer Clinical Trial
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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