Effects of Cocoa Products on Cardiovascular Disease Risk Factors

Cardiovascular Diseases Clinical Trial

— CoCD  

Official title:

Effects of Cocoa Products on Cardiovascular Disease Risk Factors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00511420
• Other study ID #: Cocoa products
• Secondary ID: Ministerio de Ed
• Status: Completed
• Phase: Phase 3
• First received: August 2, 2007
• Last updated: August 2, 2007
• Start date: April 2005
• Est. completion date: December 2005

Study information

• Verified date: August 2007
• Source: University Rovira i Virgili
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Dietary Supplement:
• Cocoa product type 1
6 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks.
• 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
• 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
• 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

Locations

Country	Name	City	State
Spain	Universitat Rovira i Virgili and Hospital Universitari Sant Joan	Reus	Tarragona

Sponsors (1)

Lead Sponsor	Collaborator
University Rovira i Virgili

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure changes between baseline and the end of intervention		4 weeks
Secondary	Plasma lipids, lipoproteins and apolipoproteins		4 weeks
Secondary	Endothelial dysfunction, oxidation and inflammation markers		4 weeks