Pomegranate Extract Supplementation in Colorectal Cancer Patients
- Conditions
- Colorectal Cancer
- Interventions
- Dietary Supplement: Standard pomegranate extract formulationDietary Supplement: Pomegranate extract formulation-1Dietary Supplement: Pomegranate extract formulation-2
- Registration Number
- NCT01916239
- Lead Sponsor
- National Research Council, Spain
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard pomegranate extract formulation Standard pomegranate extract formulation Standard pomegranate extract formulation containing 20% punicalagin Pomegranate extract formulation-1 Pomegranate extract formulation-1 New pomegranate extract formulation-1 Pomegranate extract formulation-2 Pomegranate extract formulation-2 New pomegranate extract formulation-2
- Primary Outcome Measures
Name Time Method Phenolics and derived metabolites in colon tissues, plasma and urine. Change from baseline at 15 days Occurrence of phenolics and gut-microbiota derived metabolites in tumoral and colon tissues, urine and plasma.
Gene expression profiling in colon tissues Change from baseline at 15 days Gene expression profile changes in tumoral and normal colon tissues
- Secondary Outcome Measures
Name Time Method IGF-1 (insulin-like growth factor-1) Change from baseline at 15 days Change in circulating IGF-1 levels
CEA (carcnoembryonic antigen) Change from baseline at 15 days Change in circulating CEA levels
Number of patients with adverse events as a measure of safety and tolerability Change from baseline at 15 days * 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 expression profiling in colon tissues Change from baseline at 15 days microRNA (miR) expression profile change in tumoral and normal colon tissues
Trial Locations
- Locations (1)
Hospital General Universitario Reina Sofía
🇪🇸Murcia, Spain