NCT01916239

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: National Research Council, Spain · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Standard pomegranate extract formulation	Standard pomegranate extract formulation containing 20% punicalagin
DIETARY_SUPPLEMENT	Pomegranate extract formulation-1	New pomegranate extract formulation-1
DIETARY_SUPPLEMENT	Pomegranate extract formulation-2	New pomegranate extract formulation-2

Timeline

• Start date: 2012-06-01
• Primary completion: 2015-02-01
• Completion: 2015-04-01
• First posted: 2013-08-05
• Last updated: 2015-04-14

Locations

1 site across 1 country: Spain