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

This study has been completed.
Sponsor:
Information provided by:
University Rovira i Virgili
ClinicalTrials.gov Identifier:
NCT00511420
First received: August 2, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  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

Further study details as provided by University Rovira i Virgili:

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

Secondary Outcome Measures:
  • 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
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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Please refer to this study by its ClinicalTrials.gov identifier: 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.
  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 October 22, 2014