Colorectal CancerPhase 1/2POMEcolonNCT01916239
Pomegranate Extract Supplementation in Colorectal Cancer Patients
A Phase 1/2 study testing Standard pomegranate extract formulation, Pomegranate extract formulation-1 and Pomegranate extract formulation-2 in people with Colorectal Cancer, run by National Research Council, Spain at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Standard pomegranate extract formulation, Pomegranate extract formulation-1 and Pomegranate extract formulation-2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2012to Apr 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Phase I-II Study of Pomegranate Extract Formulations in Colorectal Cancer Patients: Metabolic and Gene Expression Profiling in Tumoral and Normal Colon Tissues
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
- Being tested
- Standard pomegranate extract formulation, Pomegranate extract formulation-1, Pomegranate extract formulation-2
- Keywords
- Pomegranate, Urolithins, Colorectal cancer, Colon cancer, Metabolite, Gene expression, microRNA, Nutraceutical, Food supplement, Polyphenol, Gut microbiota
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard pomegranate extract formulationDietary supplement
Standard pomegranate extract formulation containing 20% punicalagin
Pomegranate extract formulation-1Dietary supplement
New pomegranate extract formulation-1
Pomegranate extract formulation-2Dietary supplement
New pomegranate extract formulation-2
| Study group | Role | What they receive |
|---|---|---|
| Standard pomegranate extract formulation | Experimental | Standard pomegranate extract formulation containing 20% punicalagin Receives: Dietary Supplement: Standard pomegranate extract formulation |
| Pomegranate extract formulation-1 | Experimental | New pomegranate extract formulation-1 Receives: Dietary Supplement: Pomegranate extract formulation-1 |
| Pomegranate extract formulation-2 | Experimental | New pomegranate extract formulation-2 Receives: Dietary Supplement: Pomegranate extract formulation-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline at 15 days
Gene expression profiling in colon tissues
Gene expression profile changes in tumoral and normal colon tissues
Measured: Change from baseline at 15 days
Secondary outcomes (4)
IGF-1 (insulin-like growth factor-1)
Change in circulating IGF-1 levels
Measured: Change from baseline at 15 days
CEA (carcnoembryonic antigen)
Change in circulating CEA levels
Measured: Change from baseline at 15 days
Number of patients with adverse events as a measure of safety and tolerability
- 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.
Measured: Change from baseline at 15 days
microRNA expression profiling in colon tissues
microRNA (miR) expression profile change in tumoral and normal colon tissues
Measured: Change from baseline at 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study startJun 2012
- Primary completionFeb 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research Council, Spain
- Sponsor type
- Other government
- Collaborators
- Hospital Universitario Reina Sofia de Cordoba
- Responsible party
- Principal investigator, Juan Carlos Espín de Gea, National Research Council, Spain
- Investigators
- Dr. Juan Carlos Espín, PhD, Principal investigator, National Research Council (CEBAS-CSIC, Murcia, Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916239
- Sponsor's protocol ID
- CEBAS-CSIC-2
- Acronym
- POMEcolon
- Status last verified
- Apr 2015
- First submitted
- 30 Jul 2013
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28347564Nunez-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.
PubMed 28183047
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I-II Study of Pomegranate Extract Formulations in Colorectal Cancer Patients: Metabolic and Gene Expression Profiling in Tumoral and Normal Colon Tissues
- ClinicalTrials.gov ID
- NCT01916239
- Acronym / sponsor ID
- POMEcolon / CEBAS-CSIC-2
- Conditions
- Colorectal Cancer
- Keywords
- Pomegranate, Urolithins, Colorectal cancer, Colon cancer, Metabolite, Gene expression, microRNA, Nutraceutical
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Research Council, SpainOther government
- Collaborators
- Hospital Universitario Reina Sofia de Cordoba
- Study start
- Jun 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 5 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard pomegranate extract formulation | Experimental | Dietary Supplement: Standard pomegranate extract formulationStandard pomegranate extract formulation containing 20% punicalagin |
| Pomegranate extract formulation-1 | Experimental | Dietary Supplement: Pomegranate extract formulation-1New pomegranate extract formulation-1 |
| Pomegranate extract formulation-2 | Experimental | Dietary Supplement: Pomegranate extract formulation-2New pomegranate extract formulation-2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Colorectal cancer diagnosis.
- Surgery required.
- WHO status: between 0 and 2.
- Hemoglobin >10 g/dL
- ALT >2.5-fold above the normal value.
Key exclusion criteria (6 listed)
- Patients who do not satisfy inclusion criteria and,
- Active pectic ulcer.
- Pregnancy or breastfeeding.
- Alcoholism.
- Chemotherapy or radiotherapy a month prior to recruitment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard pomegranate extract formulationStandard pomegranate extract formulation containing 20% punicalagin | Dietary supplement | Standard pomegranate extract formulation |
| Pomegranate extract formulation-1New pomegranate extract formulation-1 | Dietary supplement | Pomegranate extract formulation-1 |
| Pomegranate extract formulation-2New pomegranate extract formulation-2 | Dietary supplement | Pomegranate extract formulation-2 |
Primary outcome
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.
Gene expression profiling in colon tissues
Time frame: Change from baseline at 15 days
Gene expression profile changes in tumoral and normal colon tissues
4 secondary outcomes
IGF-1 (insulin-like growth factor-1)
Time frame: Change from baseline at 15 days
CEA (carcnoembryonic antigen)
Time frame: Change from baseline at 15 days
Number of patients with adverse events as a measure of safety and tolerability
Time frame: Change from baseline at 15 days
microRNA expression profiling in colon tissues
Time frame: Change from baseline at 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2015.
- Derived from this study: PubMed 28347564Selma 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.
- Derived from this study: PubMed 28183047Nunez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Juan Carlos Espín, PhD principal investigator
National Research Council (CEBAS-CSIC, Murcia, Spain)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Standard pomegranate extract formulation, Pomegranate extract formulation-1 and Pomegranate extract formulation-2 in people with Colorectal Cancer, run by National Research Council, Spain at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phenolics and derived metabolites in colon tissues, plasma and urine. (time frame: Change from baseline at 15 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01916239, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2015.