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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Standard pomegranate extract formulation containing 20% punicalagin
New pomegranate extract formulation-1
New pomegranate extract formulation-2
Hospital General Universitario Reina Sofía
Murcia, Murcia, Spain
Phenolics and derived metabolites in colon tissues, plasma and urine.
Occurrence of phenolics and gut-microbiota derived metabolites in tumoral and colon tissues, urine and plasma.
Time frame: Change from baseline at 15 days
Gene expression profiling in colon tissues
Gene expression profile changes in tumoral and normal colon tissues
Time frame: Change from baseline at 15 days
IGF-1 (insulin-like growth factor-1)
Change in circulating IGF-1 levels
Time frame: Change from baseline at 15 days
CEA (carcnoembryonic antigen)
Change in circulating CEA levels
Time frame: Change from baseline at 15 days
Number of patients with adverse events as a measure of safety and tolerability
* 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.
Time frame: Change from baseline at 15 days
microRNA expression profiling in colon tissues
microRNA (miR) expression profile change in tumoral and normal colon tissues
Time frame: Change from baseline at 15 days
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