Healia Clinical Trials Information Database

Effects of Cocoa Products on Cardiovascular Disease Risk Factors

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).

Status: Completed (Phase 3). Started on April 1st, 2005. Ended on December 1st, 2005.

Enrollment: 113 subjects

Study Type: Interventional

Study Design:

  • Prevention
  • Randomized
  • Double-Blind
  • Active Control
  • Parallel Assignment
  • Safety/Efficacy Study

Conditions:

Interventions:

  • Dietary Supplement: Cocoa product type 1
  • Dietary Supplement: Cocoa product type 2
  • Dietary Supplement: Cocoa product type 3
  • Dietary Supplement: Cocoa product type 4

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.
Gender

Both

Mininum Age

18 Years

Maximum Age

75 Years

Healthy Volunteers

Accepts Healthy Volunteers


Resources

Source: University Rovira i Virgili

Authority: Spain: Ethics Committee

Locations

  • Universitat Rovira i Virgili and Hospital Universitari Sant Joan
    Reus
    Tarragona
    43201
    Spain

Officials

  • Rosa Sola, Dra/Prof (Principal Investigator, Universitat Rovira i Virgili)

  • Bartolome Ramirez, Mr (Principal Investigator, La Morella Nuts, S.A.)

Sponsors

  • University Rovira i Virgili (Lead Sponsor)

References

None.

Links

None.


Date Verified
August 1st, 2007
First Received
August 2nd, 2007
Last Changed
August 2nd, 2007

Information obtained from ClinicalTrials.gov on July 15, 2008. Link to the current ClinicalTrials.gov record.


All data in the Healia Clinical Trials Information Database and content displayed by the Healia Clinical Trials Search Engine are licensed from the National Institutes of Health (National Library of Medicine), which collects and maintains the data.

The Healia Clinical Trials Search Engine searches the data set at clinicaltrials.gov, providing up-to-date information about current clinical trials. In the Healia Clinical Trials Database you can find information on new experimental drugs, medical devices, and other types of treatments for all types of diseases. Each clinical trial description includes information about the phase of the trial (phase I, phase II, or phase III), the trial’s methods, such as whether it is a randomized, placebo controlled, double blind study, and the status of the trial including whether or not the trial is currently enrolling new participants.


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