Pomegranate Extract Supplementation in Colorectal Cancer Patients (POMEcolon)

Higher Council for Scientific Research (CSIC)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Colorectal Cancer

Treatments: Dietary Supplement: Pomegranate extract formulation-2; Dietary Supplement: Pomegranate extract formulation-1; Dietary Supplement: Standard pomegranate extract formulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01916239

CEBAS-CSIC-2

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Standard pomegranate extract formulation

Experimental group

Description:

Standard pomegranate extract formulation containing 20% punicalagin

Treatment:

Dietary Supplement: Standard pomegranate extract formulation

Pomegranate extract formulation-1

Experimental group

Description:

New pomegranate extract formulation-1

Treatment:

Dietary Supplement: Pomegranate extract formulation-1

Pomegranate extract formulation-2

Experimental group

Description:

New pomegranate extract formulation-2

Treatment:

Dietary Supplement: Pomegranate extract formulation-2