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Pomegranate

Cola

Standard pomegranate extract formulation containing 20% punicalagin

Standard pomegranate extract formulation

Pomegranate extract formulation-1

Pomegranate extract formulation-2

Dr. Juan Carlos Espín, PhD

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.

Pomegranate Extract Supplementation in Colorectal Cancer Patients

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

Occurrence of phenolics and gut-microbiota derived metabolites in tumoral and colon tissues, urine and plasma.

Gene expression profile changes in tumoral and normal colon tissues

* Change in markers involved in hepatic and renal functions: GGT, AST, ALP, ALT, CPK, urate, creatinin, albumin, bilirubin, LDH.
* Change in hematological variables: leucocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, hemoglobin, hematocrit, mean corpuscular volume, mean platelet volume, platelets, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration.
* Intolerance, dyspepsia, allergic reactions, constipation, diarrhea, abdominal pain, nausea.

microRNA (miR) expression profile change in tumoral and normal colon tissues

Hospital Universitario Reina Sofia de Cordoba

National Research Council, Spain

Full Research Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pomegranate Extract Supplementation in Colorectal Cancer Patients	NCT01916239	Colorectal Canc...	Standard pomegr... Pomegranate ext... Pomegranate ext...	18 Years -	National Research Council, Spain
Pomegranate Extract Supplementation in Colorectal Cancer Patients	NCT01916239	Colorectal Canc...	Standard pomegr... Pomegranate ext... Pomegranate ext...	18 Years -	National Research Council, Spain
Pomegranate Extract Supplementation in Colorectal Cancer Patients	NCT01916239	Colorectal Canc...	Standard pomegr... Pomegranate ext... Pomegranate ext...	18 Years -	National Research Council, Spain

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