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

August 2, 2007 updated by: University Rovira i Virgili
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

113

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Cocoa and other ingredients (product type 1). This product is a control of type 2.
Dietary supplement: Cocoa product type 1
6 doses of 13 grams per day during 4 weeks with a prior stabilization period of 2 weeks.
Placebo Comparator: 2
Cocoa plus hazelnuts and other ingredients (product type 2). This product is a control of type 3 and 4.
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
Active Comparator: 3
Cocoa plus hazelnuts and other ingredients (cocoa product type 3).
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
Active Comparator: 4
Cocoa, hazelnuts and other ingredients called LMN (cocoa product type 4).
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood pressure changes between baseline and the end of intervention
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma lipids, lipoproteins and apolipoproteins
Time Frame: 4 weeks
4 weeks
Endothelial dysfunction, oxidation and inflammation markers
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Rovira i Virgili

Investigators

  • Principal Investigator: Rosa Sola, Dra/Prof, University Rovira i Virgili
  • Principal Investigator: Bartolome Ramirez, Mr, La Morella Nuts, S.A.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

August 2, 2007

First Submitted That Met QC Criteria

August 2, 2007

First Posted (Estimate)

August 3, 2007

Study Record Updates

Last Update Posted (Estimate)

August 3, 2007

Last Update Submitted That Met QC Criteria

August 2, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cocoa products
  • Ministerio de Educacion

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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