Clinical trial NCT00511420: Effects of Cocoa Products on Cardiovascular Disease Risk Factors
Official title: Effects of Cocoa Products on Cardiovascular Disease Risk Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiovascular Diseases
Keywords: cocoa
cardiovascular disease
blood pressure
Lead sponsor: University Rovira i Virgili
Sponsor class: OTHER
First posted: 2007-08-03
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: Blood pressure changes between baseline and the end of intervention
timeFrame: 4 weeks
Secondary outcomes:
measure: Plasma lipids, lipoproteins and apolipoproteins
timeFrame: 4 weeks
measure: Endothelial dysfunction, oxidation and inflammation markers
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Reus
country: Spain
facility: Universitat Rovira i Virgili and Hospital Universitari Sant Joan
state: Tarragona
Study officials:
affiliation: University Rovira i Virgili
name: Rosa Sola, Dra/Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: La Morella Nuts, S.A.
name: Bartolome Ramirez, Mr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.