Effects of Cocoa Products on Cardiovascular Disease Risk Factors

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Effects of Cocoa Products on Cardiovascular Disease Risk Factors

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Dietary Supplement: Cocoa product type 1
* Dietary Supplement: Cocoa product type 2
* Dietary Supplement: Cocoa product type 3
* Dietary Supplement: Cocoa product type 4


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Cocoa and other ingredients (product type 1). This product is a control of type 2. | Dietary Supplement: Cocoa product type 1<br>* 6 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks.<br>|
| Placebo Comparator: 2<br>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<br>* 6 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks with cocoa product type 1<br>|
| Active Comparator: 3<br>Cocoa plus hazelnuts and other ingredients (cocoa product type 3). | Dietary Supplement: Cocoa product type 3<br>* 6 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks with cocoa product type 1<br>|
| Active Comparator: 4<br>Cocoa, hazelnuts and other ingredients called LMN (cocoa product type 4). | Dietary Supplement: Cocoa product type 4<br>* 6 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks with cocoa product type 1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure changes between baseline and the end of intervention |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma lipids, lipoproteins and apolipoproteins |  | 4 weeks | 
| Endothelial dysfunction, oxidation and inflammation markers |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cocoa, cardiovascular disease, blood pressure