Effects of Cocoa Products on Cardiovascular Disease Risk Factors (CoCD)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiovascular Diseases |
Dietary Supplement: Cocoa product type 1 Dietary Supplement: Cocoa product type 2 Dietary Supplement: Cocoa product type 3 Dietary Supplement: Cocoa product type 4 |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | Effects of Cocoa Products on Cardiovascular Disease Risk Factors |
- Blood pressure changes between baseline and the end of intervention [ Time Frame: 4 weeks ]
- Plasma lipids, lipoproteins and apolipoproteins [ Time Frame: 4 weeks ]
- Endothelial dysfunction, oxidation and inflammation markers [ Time Frame: 4 weeks ]
| Enrollment: | 113 |
| Study Start Date: | April 2005 |
| Study Completion Date: | December 2005 |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 1
Cocoa and other ingredients (product type 1). This product is a control of type 2.
|
Dietary Supplement: Cocoa product type 1
6 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks.
|
|
Placebo Comparator: 2
Cocoa plus hazelnuts and other ingredients (product type 2). This product is a control of type 3 and 4.
|
Dietary Supplement: Cocoa product type 2
6 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks with cocoa product type 1
|
|
Active Comparator: 3
Cocoa plus hazelnuts and other ingredients (cocoa product type 3).
|
Dietary Supplement: Cocoa product type 3
6 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks with cocoa product type 1
|
|
Active Comparator: 4
Cocoa, hazelnuts and other ingredients called LMN (cocoa product type 4).
|
Dietary Supplement: Cocoa product type 4
6 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks with cocoa product type 1
|
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).
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations| Spain | |
| Universitat Rovira i Virgili and Hospital Universitari Sant Joan | |
| Reus, Tarragona, Spain, 43201 | |
| Principal Investigator: | Rosa Sola, Dra/Prof | Universitat Rovira i Virgili |
| Principal Investigator: | Bartolome Ramirez, Mr | La Morella Nuts, S.A. |
More Information
No publications provided by University Rovira i Virgili
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00511420 History of Changes |
| Other Study ID Numbers: | Cocoa products, Ministerio de Educacion |
| Study First Received: | August 2, 2007 |
| Last Updated: | August 2, 2007 |
| Health Authority: | Spain: Ethics Committee |
Keywords provided by University Rovira i Virgili:
|
cocoa cardiovascular disease blood pressure |
Additional relevant MeSH terms:
|
Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 22, 2013