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| ID | Type | Description | Link |
|---|---|---|---|
| Ministerio de Educacion |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Cocoa and other ingredients (product type 1). This product is a control of type 2. |
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| 2 | Placebo Comparator | Cocoa plus hazelnuts and other ingredients (product type 2). This product is a control of type 3 and 4. |
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| 3 | Active Comparator | Cocoa plus hazelnuts and other ingredients (cocoa product type 3). |
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| 4 | Active Comparator | Cocoa, hazelnuts and other ingredients called LMN (cocoa product type 4). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cocoa product type 1 | Dietary Supplement | 6 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure changes between baseline and the end of intervention | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma lipids, lipoproteins and apolipoproteins | 4 weeks | |
| Endothelial dysfunction, oxidation and inflammation markers | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rosa Sola, Dra/Prof | University Rovira i Virgili | Principal Investigator |
| Bartolome Ramirez, Mr | La Morella Nuts, S.A. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitat Rovira i Virgili and Hospital Universitari Sant Joan | Reus | Tarragona | 43201 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23840361 | Derived | 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. | |
| 22383996 |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| Cocoa product type 2 | Dietary Supplement | 6 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks with cocoa product type 1 |
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| Cocoa product type 3 | Dietary Supplement | 6 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks with cocoa product type 1 |
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| Cocoa product type 4 | Dietary Supplement | 6 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks with cocoa product type 1 |
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| Sola 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. |