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| Name | Class |
|---|---|
| Hospital Universitario Reina Sofia de Cordoba | OTHER_GOV |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard pomegranate extract formulation | Experimental | Standard pomegranate extract formulation containing 20% punicalagin |
|
| Pomegranate extract formulation-1 | Experimental | New pomegranate extract formulation-1 |
|
| Pomegranate extract formulation-2 | Experimental | New pomegranate extract formulation-2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard pomegranate extract formulation | Dietary Supplement | Standard pomegranate extract formulation containing 20% punicalagin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phenolics and derived metabolites in colon tissues, plasma and urine. | Occurrence of phenolics and gut-microbiota derived metabolites in tumoral and colon tissues, urine and plasma. | Change from baseline at 15 days |
| Gene expression profiling in colon tissues | Gene expression profile changes in tumoral and normal colon tissues | Change from baseline at 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| IGF-1 (insulin-like growth factor-1) | Change in circulating IGF-1 levels | Change from baseline at 15 days |
| CEA (carcnoembryonic antigen) | Change in circulating CEA levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Juan Carlos EspÃn, PhD | National Research Council (CEBAS-CSIC, Murcia, Spain) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Universitario Reina SofÃa | Murcia | Murcia | 30003 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28347564 | Derived | Selma MV, Gonzalez-Sarrias A, Salas-Salvado J, Andres-Lacueva C, Alasalvar C, Orem A, Tomas-Barberan FA, Espin JC. The gut microbiota metabolism of pomegranate or walnut ellagitannins yields two urolithin-metabotypes that correlate with cardiometabolic risk biomarkers: Comparison between normoweight, overweight-obesity and metabolic syndrome. Clin Nutr. 2018 Jun;37(3):897-905. doi: 10.1016/j.clnu.2017.03.012. Epub 2017 Mar 16. | |
| 28183047 |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Pomegranate extract formulation-1 | Dietary Supplement | New pomegranate extract formulation-1 |
|
| Pomegranate extract formulation-2 | Dietary Supplement | New pomegranate extract formulation-2 |
|
| Change from baseline at 15 days |
| Number of patients with adverse events as a measure of safety and tolerability |
| Change from baseline at 15 days |
| microRNA expression profiling in colon tissues | microRNA (miR) expression profile change in tumoral and normal colon tissues | Change from baseline at 15 days |
| Derived |
| Nunez-Sanchez MA, Gonzalez-Sarrias A, Garcia-Villalba R, Monedero-Saiz T, Garcia-Talavera NV, Gomez-Sanchez MB, Sanchez-Alvarez C, Garcia-Albert AM, Rodriguez-Gil FJ, Ruiz-Marin M, Pastor-Quirante FA, Martinez-Diaz F, Tomas-Barberan FA, Espin JC, Garcia-Conesa MT. Gene expression changes in colon tissues from colorectal cancer patients following the intake of an ellagitannin-containing pomegranate extract: a randomized clinical trial. J Nutr Biochem. 2017 Apr;42:126-133. doi: 10.1016/j.jnutbio.2017.01.014. Epub 2017 Jan 27. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |