NCT00511420

Effects of Cocoa Products on Cardiovascular Disease Risk Factors

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: University Rovira i Virgili · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

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).

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
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

Timeline

• Start date: 2005-04-01
• Completion: 2005-12-01
• First posted: 2007-08-03
• Last updated: 2007-08-03

Locations

1 site across 1 country: Spain