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Effect of Cocoa Consumption in Cardiovascular and Immune Parameters

Primary Purpose

Arterial Hypertension

Status
Terminated
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Dark chocolate
White chocolate
Sponsored by
Universidad de Antioquia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arterial Hypertension

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sede Investigaciones Universitarias, Universidad de Antioquia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dark chocolate

White chocolate

Arm Description

Presence of 70% cocoa solids

Outcomes

Primary Outcome Measures

Change in diastolic blood pressure
Measurement of the diastolic blood pressure with the ambulatory blood pressure monitoring

Secondary Outcome Measures

Change in systolic blood pressure
Measurement of the systolic blood pressure with the ambulatory blood pressure monitoring
Change in total cholesterol
Change in low density lipoprotein cholesterol
Change in high density lipoprotein cholesterol
Change in triglycerides levels
Change in hs-CRP
Change in IL-1 beta levels
Change in IL-2 levels
Change in tumor necrosis factor alpha levels
Change in flow mediated dilatation of the brachial artery

Full Information

First Posted
November 24, 2011
Last Updated
December 16, 2011
Sponsor
Universidad de Antioquia
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1. Study Identification

Unique Protocol Identification Number
NCT01496235
Brief Title
Effect of Cocoa Consumption in Cardiovascular and Immune Parameters
Official Title
Randomized Clinical Trial of the Effect of Cocoa Consumption in Cardiovascular and Immune Parameters in Colombian Patients With Newly Diagnosed Stage 1 Arterial Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Terminated
Why Stopped
Difficulties with the patient recruitment
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Antioquia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dark chocolate
Arm Type
Active Comparator
Arm Description
Presence of 70% cocoa solids
Arm Title
White chocolate
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Dark chocolate
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
White chocolate
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in diastolic blood pressure
Description
Measurement of the diastolic blood pressure with the ambulatory blood pressure monitoring
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Change in systolic blood pressure
Description
Measurement of the systolic blood pressure with the ambulatory blood pressure monitoring
Time Frame
Baseline and 12 weeks
Title
Change in total cholesterol
Time Frame
Baseline and 12 weeks
Title
Change in low density lipoprotein cholesterol
Time Frame
Baseline and 12 weeks
Title
Change in high density lipoprotein cholesterol
Time Frame
Baseline and 12 weeks
Title
Change in triglycerides levels
Time Frame
Baseline and 12 weeks
Title
Change in hs-CRP
Time Frame
Baseline and 12 weeks
Title
Change in IL-1 beta levels
Time Frame
Baseline and 12 weeks
Title
Change in IL-2 levels
Time Frame
Baseline and 12 weeks
Title
Change in tumor necrosis factor alpha levels
Time Frame
Baseline and 12 weeks
Title
Change in flow mediated dilatation of the brachial artery
Time Frame
Baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica L Giraldo, PhD
Organizational Affiliation
Universidad de Antioquia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sede Investigaciones Universitarias, Universidad de Antioquia
City
Medellín
State/Province
Antioquia
Country
Colombia

12. IPD Sharing Statement

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Effect of Cocoa Consumption in Cardiovascular and Immune Parameters

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