Effects of Cocoa Products on Cardiovascular Disease Risk Factors

NCT ID: NCT00511420

Last Updated: 2007-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2005-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

1

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

Group Type: PLACEBO_COMPARATOR

Cocoa product type 1

Intervention Type: DIETARY_SUPPLEMENT

6 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks.

2

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

Group Type: PLACEBO_COMPARATOR

Cocoa product type 2

Intervention Type: DIETARY_SUPPLEMENT

6 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks with cocoa product type 1

3

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

Group Type: ACTIVE_COMPARATOR

Cocoa product type 3

Intervention Type: DIETARY_SUPPLEMENT

6 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks with cocoa product type 1

4

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

Group Type: ACTIVE_COMPARATOR

Cocoa product type 4

Intervention Type: DIETARY_SUPPLEMENT

6 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks with cocoa product type 1

Interventions

Cocoa product type 1

6 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks.

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Rovira i Virgili

OTHER

Sponsor Role: lead

Principal Investigators

Rosa Sola, Dra/Prof

Role: PRINCIPAL_INVESTIGATOR

University Rovira i Virgili

Bartolome Ramirez, Mr

Role: PRINCIPAL_INVESTIGATOR

La Morella Nuts, S.A.

Locations

Universitat Rovira i Virgili and Hospital Universitari Sant Joan

Reus, Tarragona, Spain

Countries

Spain

References

Crescenti A, Sola R, Valls RM, Caimari A, Del Bas JM, Anguera A, Angles N, Arola L. Cocoa Consumption Alters the Global DNA Methylation of Peripheral Leukocytes in Humans with Cardiovascular Disease Risk Factors: A Randomized Controlled Trial. PLoS One. 2013 Jun 26;8(6):e65744. doi: 10.1371/journal.pone.0065744. Print 2013.

Reference Type: DERIVED

PMID: 23840361 (View on PubMed)

Sola R, Valls RM, Godas G, Perez-Busquets G, Ribalta J, Girona J, Heras M, Cabre A, Castro A, Domenech G, Torres F, Masana L, Angles N, Reguant J, Ramirez B, Barriach JM. Cocoa, hazelnuts, sterols and soluble fiber cream reduces lipids and inflammation biomarkers in hypertensive patients: a randomized controlled trial. PLoS One. 2012;7(2):e31103. doi: 10.1371/journal.pone.0031103. Epub 2012 Feb 27.

Reference Type: DERIVED

PMID: 22383996 (View on PubMed)

Other Identifiers

Ministerio de Educacion

Identifier Type: -

Identifier Source: secondary_id

Cocoa products

Identifier Type: -

Identifier Source: org_study_id