Effect of Cocoa Consumption in Cardiovascular and Immune Parameters

December 16, 2011 updated by: Monica Lucia Giraldo, Universidad de Antioquia

Randomized Clinical Trial of the Effect of Cocoa Consumption in Cardiovascular and Immune Parameters in Colombian Patients With Newly Diagnosed Stage 1 Arterial Hypertension

Arterial hypertension is one of the most preventable risk factors for stroke, cardiovascular and renal disease. Cocoa is rich in a subclass of flavonoid called flavanol this increase nitric oxide production and is involved in controlling blood pressure.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Not Applicable

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

  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia
        • Sede Investigaciones Universitarias, Universidad de Antioquia

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age: 18 - 65 years old
  • Resides in Medellín City
  • Attached from the contributive regimen of Colombian Health System
  • Essential Arterial Hypertension, stage I. Diagnosis less than 3 months.
  • Medically indicated non-pharmacological therapy.
  • Voluntary desire to consume 50 grams of chocolate per day for 12 weeks.
  • Voluntary desire to participate in the trial and sign informed consent.

Exclusion Criteria:

  • Suspect of secondary hypertension
  • Suspect of injury in target organ
  • Presence of diabetes mellitus
  • BMI (Body Mass Index) major or equal to 30
  • Present smoker or with less than four weeks of abstinence of tobacco
  • Consume antiplatelet substances
  • Regular consumption of antioxidants, multivitamins, anti-inflammatory medications, drugs for nasal congestion and sibutramine

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dark chocolate
Presence of 70% cocoa solids
Dietary supplement: Dark chocolate
Each chocolate bar provided 210 calories represented in 25 grams of carbohydrates, 3 g of proteins, 18 g of total fat and the presence of 70% cocoa solids
Placebo Comparator: White chocolate
Dietary supplement: White chocolate
Each chocolate bar provided 230 calories represented in 28 grams of carbohydrates, 3 g of proteins, 18 g of total fat, without the presence of 70% cocoa solids

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in diastolic blood pressure
Time Frame: Baseline and 12 weeks
Measurement of the diastolic blood pressure with the ambulatory blood pressure monitoring
Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in systolic blood pressure
Time Frame: Baseline and 12 weeks
Measurement of the systolic blood pressure with the ambulatory blood pressure monitoring
Baseline and 12 weeks
Change in total cholesterol
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Change in low density lipoprotein cholesterol
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Change in high density lipoprotein cholesterol
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Change in triglycerides levels
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Change in hs-CRP
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Change in IL-1 beta levels
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Change in IL-2 levels
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Change in tumor necrosis factor alpha levels
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Change in flow mediated dilatation of the brachial artery
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks

Collaborators and Investigators

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

Sponsor

Universidad de Antioquia

Investigators

  • Principal Investigator: Monica L Giraldo, PhD, Universidad de Antioquia

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

July 1, 2009

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

November 24, 2011

First Submitted That Met QC Criteria

December 16, 2011

First Posted (Estimate)

December 21, 2011

Study Record Updates

Last Update Posted (Estimate)

December 21, 2011

Last Update Submitted That Met QC Criteria

December 16, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cacao I

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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