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

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ClinicalTrials.gov Identifier: NCT00511420
Recruitment Status : Completed
First Posted : August 3, 2007
Last Update Posted : August 3, 2007
Sponsor:
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment 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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Effects of Cocoa Products on Cardiovascular Disease Risk Factors
Study Start Date : April 2005
Study Completion Date : December 2005
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Blood pressure changes between baseline and the end of intervention [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Plasma lipids, lipoproteins and apolipoproteins [ Time Frame: 4 weeks ]
  2. Endothelial dysfunction, oxidation and inflammation markers [ Time Frame: 4 weeks ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00511420


Locations
Spain
Universitat Rovira i Virgili and Hospital Universitari Sant Joan
Reus, Tarragona, Spain, 43201
Sponsors and Collaborators
University Rovira i Virgili
Investigators
Principal Investigator: Rosa Sola, Dra/Prof Universitat Rovira i Virgili
Principal Investigator: Bartolome Ramirez, Mr La Morella Nuts, S.A.