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Effects of Cocoa Products on Cardiovascular Disease Risk Factors (CoCD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00511420
First Posted: August 3, 2007
Last Update Posted: August 3, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Rovira i Virgili
August 2, 2007
August 3, 2007
August 3, 2007
April 2005
Not Provided
Blood pressure changes between baseline and the end of intervention [ Time Frame: 4 weeks ]
Same as current
No Changes Posted
  • Plasma lipids, lipoproteins and apolipoproteins [ Time Frame: 4 weeks ]
  • Endothelial dysfunction, oxidation and inflammation markers [ Time Frame: 4 weeks ]
Same as current
Not Provided
Not Provided
 
Effects of Cocoa Products on Cardiovascular Disease Risk Factors
Effects of Cocoa Products on Cardiovascular Disease Risk Factors
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).

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Cardiovascular Diseases
  • Dietary Supplement: Cocoa product type 1
    6 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks.
  • 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
  • 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
  • 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
  • Placebo Comparator: 1
    Cocoa and other ingredients (product type 1). This product is a control of type 2.
    Intervention: Dietary Supplement: Cocoa product type 1
  • Placebo Comparator: 2
    Cocoa plus hazelnuts and other ingredients (product type 2). This product is a control of type 3 and 4.
    Intervention: Dietary Supplement: Cocoa product type 2
  • Active Comparator: 3
    Cocoa plus hazelnuts and other ingredients (cocoa product type 3).
    Intervention: Dietary Supplement: Cocoa product type 3
  • Active Comparator: 4
    Cocoa, hazelnuts and other ingredients called LMN (cocoa product type 4).
    Intervention: Dietary Supplement: Cocoa product type 4

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
113
December 2005
Not Provided

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT00511420
Cocoa products
Ministerio de Educacion
No
Not Provided
Not Provided
Not Provided
University Rovira i Virgili
Not Provided
Principal Investigator: Rosa Sola, Dra/Prof Universitat Rovira i Virgili
Principal Investigator: Bartolome Ramirez, Mr La Morella Nuts, S.A.
University Rovira i Virgili
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP