Cardiovascular DiseasesPhase 3CoCDNCT00511420
Effects of Cocoa Products on Cardiovascular Disease Risk Factors
A Phase 3 study testing Cocoa product type 1, Cocoa product type 2 and Cocoa product type 3 in people with Cardiovascular Diseases, run by University Rovira i Virgili at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate the effects of optimized composition chocolates that include natural ingredients with demonstrated biological activity are observed cardioprotectores effects in the human. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Cocoa product type 1, Cocoa product type 2 and Cocoa product type 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 113 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2005to Dec 2005
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eligible participants had systolic blood pressure (BP) of 120 to 159 mm Hg or a diastolic blood pressure of 80 to 99 mm Hg. This range includes participants with prehypertension (systolic, 120-139 mm Hg or diastolic, 80-89 mm Hg) and stage 1 hypertension (systolic, 140-159 mm Hg or diastolic, 90-99 mm Hg).
- Moreover, participants' plasma LDL-cholesterol concentrations were ≥ 3.35 mmol/L (≥ 130 and ≤ 189 mg/dL) and triglyceride concentrations < 4 mmol/L (350 mg/dL) in the fasting state and at least one CVD risk factor such as age (men ≥45 years; women ≥55 years), cigarette smoking, low high density lipoprotein cholesterol concentration (<1.0 mmol/L (40 mg/dL) and <1,18 mmol/L (46 mg/dL), men and women, respectively), family history of premature CVD (in male first-degree relative <55 years of age, in female first-degree relative <65 years of age.
Who cannot join
- Assessed from the medical history and a complete physical examination, were plasma triglyceride concentrations ≥4 mmol/L (350 mg/dL), BMI >35 kg/m2, CVD clinical events, use of lipid-lowering drugs at least 2 months prior to the start of study, diabetes mellitus (at least 2 fasting glucose ≥7.0 mmol/L (≥ 126 mg/dL), renal insufficiency, thyroid or other endocrine disease.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Universitat Rovira i Virgili and Hospital Universitari Sant Joan
Reus, Tarragona, 43201
About this study
The purpose of this study is to evaluate the effects of optimized composition chocolates that include natural ingredients with demonstrated biological activity are observed cardioprotectores effects in the human.
Read the detailed description
Studies carried out during the last decades have demonstrated of conclusive form that foods like nuts, products like cocoa or other ingredients, to be consumed of isolated form or when taking several from integrated them in a same diet can contribute to the prevention or the treatment of the cardiovascular diseases.
The study was a randomized, controlled, double-blind, parallel multi-center study in which the 4 different types of cocoa products [1)cocoa and other ingredients (sugar and vegetal oils), 2)cocoa plus hazelnuts and other ingredients, 3)the same as 2 plus other ingredient and 4) cocoa, hazelnuts and other ingredients called (LMN)], introduced into a calorie-balanced diet for 4 weeks with a prior stabilization period of 2 weeks in which all participants received the cocoa product type 1. Cocoa product type 1 is a control of type 2, and types 1 and 2 were controls of types 3 and 4.
Cocoa products type 4 is registered as patent. The trial was conducted in Reus and 3 other cities in Catalonia (Alcover, Centelles and Vic) (Spain).
- Conditions
- Cardiovascular Diseases
- Being tested
- Cocoa product type 1, Cocoa product type 2, Cocoa product type 3, Cocoa product type 4
- Keywords
- cocoa, cardiovascular disease, blood pressure
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cocoa product type 1Dietary supplement
6 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks.
Cocoa product type 2Dietary supplement
6 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks with cocoa product type 1
Cocoa product type 3Dietary supplement
6 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks with cocoa product type 1
Cocoa product type 4Dietary supplement
6 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks with cocoa product type 1
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Cocoa and other ingredients (product type 1). This product is a control of type 2. Receives: Dietary Supplement: Cocoa product type 1 |
| 2 | Placebo comparator | Cocoa plus hazelnuts and other ingredients (product type 2). This product is a control of type 3 and 4. Receives: Dietary Supplement: Cocoa product type 2 |
| 3 | Active comparator | Cocoa plus hazelnuts and other ingredients (cocoa product type 3). Receives: Dietary Supplement: Cocoa product type 3 |
| 4 | Active comparator | Cocoa, hazelnuts and other ingredients called LMN (cocoa product type 4). Receives: Dietary Supplement: Cocoa product type 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure changes between baseline and the end of intervention
Measured: 4 weeks
Secondary outcomes (2)
Plasma lipids, lipoproteins and apolipoproteins
Measured: 4 weeks
Endothelial dysfunction, oxidation and inflammation markers
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2007 (estimated)
- Study startApr 2005
- Study completionDec 2005
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 Cardiovascular DiseasesStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Rovira i Virgili
- Sponsor type
- University, hospital or other
- Investigators
- Rosa Sola, Dra/Prof, Principal investigator, University Rovira i VirgiliBartolome Ramirez, Mr, Principal investigator, La Morella Nuts, S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00511420
- Sponsor's protocol ID
- Cocoa products
- Other IDs
- Ministerio de Educacion
- Acronym
- CoCD
- Status last verified
- Aug 2007
- First submitted
- 2 Aug 2007
- Last updated
- 3 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Crescenti A, Sola R, Valls RM, Caimari A, Del Bas JM, Anguera A, Angles N, Arola L. Cocoa Consumption Alters the Global DNA Methylation of Peripheral Leukocytes in Humans with Cardiovascular Disease Risk Factors: A Randomized Controlled Trial. PLoS One. 2013 Jun 26;8(6):e65744. doi: 10.1371/journal.pone.0065744. Print 2013.
PubMed 23840361Sola R, Valls RM, Godas G, Perez-Busquets G, Ribalta J, Girona J, Heras M, Cabre A, Castro A, Domenech G, Torres F, Masana L, Angles N, Reguant J, Ramirez B, Barriach JM. Cocoa, hazelnuts, sterols and soluble fiber cream reduces lipids and inflammation biomarkers in hypertensive patients: a randomized controlled trial. PLoS One. 2012;7(2):e31103. doi: 10.1371/journal.pone.0031103. Epub 2012 Feb 27.
PubMed 22383996
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cocoa Products on Cardiovascular Disease Risk Factors
- ClinicalTrials.gov ID
- NCT00511420
- Acronym / sponsor ID
- CoCD / Cocoa products
- Conditions
- Cardiovascular Diseases
- Keywords
- cocoa, cardiovascular disease, blood pressure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- University Rovira i VirgiliUniversity, hospital or other
- Study start
- Apr 2005
- Study completion
- Dec 2005 (actual)
- First posted
- 3 Aug 2007 (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 purpose of this study is to evaluate the effects of optimized composition chocolates that include natural ingredients with demonstrated biological activity are observed cardioprotectores effects in the human.
Detailed description
Studies carried out during the last decades have demonstrated of conclusive form that foods like nuts, products like cocoa or other ingredients, to be consumed of isolated form or when taking several from integrated them in a same diet can contribute to the prevention or the treatment of the cardiovascular diseases.
The study was a randomized, controlled, double-blind, parallel multi-center study in which the 4 different types of cocoa products [1)cocoa and other ingredients (sugar and vegetal oils), 2)cocoa plus hazelnuts and other ingredients, 3)the same as 2 plus other ingredient and 4) cocoa, hazelnuts and other ingredients called (LMN)], introduced into a calorie-balanced diet for 4 weeks with a prior stabilization period of 2 weeks in which all participants received the cocoa product type 1. Cocoa product type 1 is a control of type 2, and types 1 and 2 were controls of types 3 and 4.
Cocoa products type 4 is registered as patent. The trial was conducted in Reus and 3 other cities in Catalonia (Alcover, Centelles and Vic) (Spain).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Dietary Supplement: Cocoa product type 1Cocoa and other ingredients (product type 1). This product is a control of type 2. |
| 2 | Placebo comparator | Dietary Supplement: Cocoa product type 2Cocoa plus hazelnuts and other ingredients (product type 2). This product is a control of type 3 and 4. |
| 3 | Active comparator | Dietary Supplement: Cocoa product type 3Cocoa plus hazelnuts and other ingredients (cocoa product type 3). |
| 4 | Active comparator | Dietary Supplement: Cocoa product type 4Cocoa, hazelnuts and other ingredients called LMN (cocoa product type 4). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Eligible participants had systolic blood pressure (BP) of 120 to 159 mm Hg or a diastolic blood pressure of 80 to 99 mm Hg. This range includes participants with prehypertension (systolic, 120-139 mm Hg or diastolic, 80-89 mm Hg) and stage 1 hypertension (systolic, 140-159 mm Hg or diastolic, 90-99 mm Hg).
- Moreover, participants' plasma LDL-cholesterol concentrations were ≥ 3.35 mmol/L (≥ 130 and ≤ 189 mg/dL) and triglyceride concentrations < 4 mmol/L (350 mg/dL) in the fasting state and at least one CVD risk factor such as age (men ≥45 years; women ≥55 years), cigarette smoking, low high density lipoprotein cholesterol concentration (<1.0 mmol/L (40 mg/dL) and <1,18 mmol/L (46 mg/dL), men and women, respectively), family history of premature CVD (in male first-degree relative <55 years of age, in female first-degree relative <65 years of age.
Key exclusion criteria (1 listed)
- Assessed from the medical history and a complete physical examination, were plasma triglyceride concentrations ≥4 mmol/L (350 mg/dL), BMI >35 kg/m2, CVD clinical events, use of lipid-lowering drugs at least 2 months prior to the start of study, diabetes mellitus (at least 2 fasting glucose ≥7.0 mmol/L (≥ 126 mg/dL), renal insufficiency, thyroid or other endocrine disease.
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 |
|---|---|---|
| Cocoa product type 16 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks. | Dietary supplement | 1 |
| Cocoa product type 26 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks with cocoa product type 1 | Dietary supplement | 2 |
| Cocoa product type 36 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks with cocoa product type 1 | Dietary supplement | 3 |
| Cocoa product type 46 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks with cocoa product type 1 | Dietary supplement | 4 |
Primary outcome
Blood pressure changes between baseline and the end of intervention
Time frame: 4 weeks
2 secondary outcomes
Plasma lipids, lipoproteins and apolipoproteins
Time frame: 4 weeks
Endothelial dysfunction, oxidation and inflammation markers
Time frame: 4 weeks
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 Aug 2007.
- Derived from this study: PubMed 23840361Crescenti A, Sola R, Valls RM, Caimari A, Del Bas JM, Anguera A, Angles N, Arola L. Cocoa Consumption Alters the Global DNA Methylation of Peripheral Leukocytes in Humans with Cardiovascular Disease Risk Factors: A Randomized Controlled Trial. PLoS One. 2013 Jun 26;8(6):e65744. doi: 10.1371/journal.pone.0065744. Print 2013.
- Derived from this study: PubMed 22383996Sola R, Valls RM, Godas G, Perez-Busquets G, Ribalta J, Girona J, Heras M, Cabre A, Castro A, Domenech G, Torres F, Masana L, Angles N, Reguant J, Ramirez B, Barriach JM. Cocoa, hazelnuts, sterols and soluble fiber cream reduces lipids and inflammation biomarkers in hypertensive patients: a randomized controlled trial. PLoS One. 2012;7(2):e31103. doi: 10.1371/journal.pone.0031103. Epub 2012 Feb 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.
Rosa Sola, Dra/Prof principal investigator
University Rovira i Virgili
Bartolome Ramirez, Mr principal investigator
La Morella Nuts, S.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cocoa product type 1, Cocoa product type 2 and Cocoa product type 3 in people with Cardiovascular Diseases, run by University Rovira i Virgili 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 2 inclusion and 1 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 Aug 2007. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Blood pressure changes between baseline and the end of intervention (time frame: 4 weeks). 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 NCT00511420, 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 3 Aug 2007.