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OpenTrials
Completed

NCT Number: NCT01916239

Pomegranate Extract Supplementation in Colorectal Cancer Patients

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hospital General Universitario Reina Sofía

Murcia, 30003, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard pomegranate extract formulation

Dietary Supplement

Standard pomegranate extract formulation containing 20% punicalagin

Pomegranate extract formulation-1

Dietary Supplement

New pomegranate extract formulation-1

Pomegranate extract formulation-2

Dietary Supplement

New pomegranate extract formulation-2

Primary outcomes

  1. Phenolics and derived metabolites in colon tissues, plasma and urine.

    Time frame: Change from baseline at 15 days

    Occurrence of phenolics and gut-microbiota derived metabolites in tumoral and colon tissues, urine and plasma.

  2. Gene expression profiling in colon tissues

    Time frame: Change from baseline at 15 days

    Gene expression profile changes in tumoral and normal colon tissues

Secondary outcomes

  1. IGF-1 (insulin-like growth factor-1)

    Time frame: Change from baseline at 15 days

    Change in circulating IGF-1 levels

  2. CEA (carcnoembryonic antigen)

    Time frame: Change from baseline at 15 days

    Change in circulating CEA levels

  3. Number of patients with adverse events as a measure of safety and tolerability

    Time frame: 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.

  4. microRNA expression profiling in colon tissues

    Time frame: Change from baseline at 15 days

    microRNA (miR) expression profile change in tumoral and normal colon tissues

Sponsors and collaborators

Lead sponsor

National Research Council, Spain

Other Gov

Collaborators

  • Hospital Universitario Reina Sofia de Cordoba

Registry information

Official study title

Phase I-II Study of Pomegranate Extract Formulations in Colorectal Cancer Patients: Metabolic and Gene Expression Profiling in Tumoral and Normal Colon Tissues

Acronym: POMEcolon

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 5, 2013
Registry last updated
Apr 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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