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

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.

Inclusion Criteria:

• Colorectal cancer diagnosis.
• Surgery required.
• WHO status: between 0 and 2.
• Hemoglobin >10 g/dL
• ALT >2.5-fold above the normal value.
• Serum Bilirubin >1.5-fold above the normal value.
• Creatinine <140 micromol/L

Exclusion Criteria:

• Patients who do not satisfy inclusion criteria and,
• Active pectic ulcer.
• Pregnancy or breastfeeding.
• Alcoholism.
• Chemotherapy or radiotherapy a month prior to recruitment.
• Treatment with steroids or other anti-inflammatory drugs a week prior to recruitment.