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

University Rovira i Virgili

Status and phase: Completed; Phase 3

Conditions: Cardiovascular Diseases

Treatments: Dietary Supplement: Cocoa product type 1; Dietary Supplement: Cocoa product type 4; Dietary Supplement: Cocoa product type 3; Dietary Supplement: Cocoa product type 2

Study type: Interventional

Funder types: Other

Identifiers

NCT00511420

Cocoa products

Ministerio de Educacion

Details and patient eligibility

About

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.

Full 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).

Enrollment: 113 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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113 participants in 4 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Cocoa and other ingredients (product type 1). This product is a control of type 2.

Treatment:

Dietary Supplement: Cocoa product type 1

2

Placebo Comparator group

Description:

Cocoa plus hazelnuts and other ingredients (product type 2). This product is a control of type 3 and 4.

Treatment:

Dietary Supplement: Cocoa product type 2

3

Active Comparator group

Description:

Cocoa plus hazelnuts and other ingredients (cocoa product type 3).

Treatment:

Dietary Supplement: Cocoa product type 3

4

Active Comparator group

Description:

Cocoa, hazelnuts and other ingredients called LMN (cocoa product type 4).

Treatment:

Dietary Supplement: Cocoa product type 4