Cardiovascular FunctionNCT01681394
Effect of a Polyphenol-rich Cocoa Extract on Peripheral Blood Mononuclear Cells Gene Expression
A study testing Polyphenol-rich cocoa extract and Chocolate cream in people with Cardiovascular Function and Gene Expression, run by Technological Centre of Nutrition and Health, Spain at 1 site in Spain.
Trial summary
It has been evidenced that chocolate and cocoa consumption increase vasodilation and reduce blood pressure. However, the mechanisms implicated in these effects have not been elucidated yet. Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Function, Gene Expression
- What is being tested?
- Polyphenol-rich cocoa extract and Chocolate cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2012to Feb 2013
- Phase
- Interventional
- 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 20 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1.Healthy males between the ages of 20 and 39 who do not meet any of the exclusion criteria.
Who cannot join
- Body mass index (BMI) lower than 18 or greater than 27 Kg/m2
- Smokers
- Regular medication
- Consumption of medication during the last week
- Following a weight-loss diet
- Vegetarians
Show all 12Show fewer
- Abnormal glucose levels
- Diabetes
- Cardiovascular disease
- Gastrointestinal disease
- Anemia
- Allergy
Trial locations and contacts
1 site in 1 country.
Spain1 site
Technological Center of Nutrition and Health (CTNS)
Reus, Tarragona, 43204
About this study
Official title: Effect of the Administration of a Polyphenol-rich Cocoa Extract on Peripheral Blood Mononuclear Cells Gene Expression in Humans
It has been evidenced that chocolate and cocoa consumption increase vasodilation and reduce blood pressure. However, the mechanisms implicated in these effects have not been elucidated yet. The purpose of this study is to evaluate changes in gene expression induced by the administration of a polyphenol-rich cocoa extract in peripheral blood mononuclear cells (PBMC) in humans.
Read the detailed description
This is a prospective, randomized, controlled, double-blind and cross-over study. The intervention will consist in the administration of 250g of chocolate cream with or without the extract after 12 hours fasting. Blood samples will be taken at point 0, 2, 3 and 6 hours after the administration. At each time point, blood pressure and endothelial function (with a non-invasive method) will be measured.
- Conditions
- Cardiovascular Function, Gene Expression
- Being tested
- Polyphenol-rich cocoa extract, Chocolate cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyphenol-rich cocoa extractDietary supplement
250 g of chocolate cream supplemented with 2.3 g of polyphenol-rich cocoa extract (containing 1050 mg of total polyphenols)
Chocolate creamDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Product 1 | Active comparator | 250 g of chocolate cream supplemented with 2.3 g of polyphenol-rich cocoa extract (containing 1050 mg of total polyphenols) Receives: Dietary Supplement: Polyphenol-rich cocoa extract |
| Control product | Placebo comparator | 250 g of chocolate cream Receives: Dietary Supplement: Chocolate cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene expression changes in PBMCs (using a microarray)
Measured: 0-6 hours
Secondary outcomes (3)
Blood pressure
Measured: 0-2-3-6 hours
Endothelial function (assessed by ischemic reactive hyperemia)
Measured: 0-2-3-6 hours
Plasma levels of procyanidins metabolites
Measured: 0-6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular FunctionStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technological Centre of Nutrition and Health, Spain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rosa Solà, PhD, Principal investigator, University Rovira i Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01681394
- Sponsor's protocol ID
- PBMCS-CTNS-01
- Status last verified
- Jul 2013
- First submitted
- 5 Sep 2012
- Last updated
- 3 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Administration of a Polyphenol-rich Cocoa Extract on Peripheral Blood Mononuclear Cells Gene Expression in Humans
- ClinicalTrials.gov ID
- NCT01681394
- Acronym / sponsor ID
- PBMCS-CTNS-01
- Conditions
- Cardiovascular Function, Gene Expression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Technological Centre of Nutrition and Health, SpainUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 7 Sep 2012 (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.
It has been evidenced that chocolate and cocoa consumption increase vasodilation and reduce blood pressure. However, the mechanisms implicated in these effects have not been elucidated yet. The purpose of this study is to evaluate changes in gene expression induced by the administration of a polyphenol-rich cocoa extract in peripheral blood mononuclear cells (PBMC) in humans.
Detailed description
This is a prospective, randomized, controlled, double-blind and cross-over study. The intervention will consist in the administration of 250g of chocolate cream with or without the extract after 12 hours fasting. Blood samples will be taken at point 0, 2, 3 and 6 hours after the administration. At each time point, blood pressure and endothelial function (with a non-invasive method) will be measured.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Product 1 | Active comparator | Dietary Supplement: Polyphenol-rich cocoa extract250 g of chocolate cream supplemented with 2.3 g of polyphenol-rich cocoa extract (containing 1050 mg of total polyphenols) |
| Control product | Placebo comparator | Dietary Supplement: Chocolate cream250 g of chocolate cream |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1.Healthy males between the ages of 20 and 39 who do not meet any of the exclusion criteria.
Key exclusion criteria (12 listed)
- Body mass index (BMI) lower than 18 or greater than 27 Kg/m2
- Smokers
- Regular medication
- Consumption of medication during the last week
- Following a weight-loss diet
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 |
|---|---|---|
| Polyphenol-rich cocoa extract250 g of chocolate cream supplemented with 2.3 g of polyphenol-rich cocoa extract (containing 1050 mg of total polyphenols) | Dietary supplement | Product 1 |
| Chocolate cream | Dietary supplement | Control product |
Primary outcome
Gene expression changes in PBMCs (using a microarray)
Time frame: 0-6 hours
3 secondary outcomes
Blood pressure
Time frame: 0-2-3-6 hours
Endothelial function (assessed by ischemic reactive hyperemia)
Time frame: 0-2-3-6 hours
Plasma levels of procyanidins metabolites
Time frame: 0-6 hours
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 3 Jul 2013.
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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.
Rosa Solà, PhD principal investigator
University Rovira i Virgili
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyphenol-rich cocoa extract and Chocolate cream in people with Cardiovascular Function and Gene Expression, run by Technological Centre of Nutrition and Health, 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 1 inclusion and 12 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 3 Jul 2013. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Gene expression changes in PBMCs (using a microarray) (time frame: 0-6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jul 2013; AzTrials last refreshed its copy on 6 Nov 2026.