Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pomegranate extract formulation-1 | Dietary Supplement | — | UNRESOLVED |
| Pomegranate extract formulation-2 | Dietary Supplement | — | UNRESOLVED |
| Standard pomegranate extract formulation | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Standard pomegranate extract formulation
- description
- Standard pomegranate extract formulation containing 20% punicalagin
- interventionNames
- Dietary Supplement: Standard pomegranate extract formulation
- type
- EXPERIMENTAL
- label
- Pomegranate extract formulation-1
- description
- New pomegranate extract formulation-1
- interventionNames
- Dietary Supplement: Pomegranate extract formulation-1
- type
- EXPERIMENTAL
- label
- Pomegranate extract formulation-2
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDSelma 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. PMID 28347564
- DERIVEDNunez-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. PMID 28183047