Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Cocoa Consumption in Cardiovascular and Immune Parameters

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01496235
Recruitment Status : Terminated (Difficulties with the patient recruitment)
First Posted : December 21, 2011
Last Update Posted : December 21, 2011
Sponsor:
Information provided by (Responsible Party):
Monica Lucia Giraldo, Universidad de Antioquia

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Arterial Hypertension Dietary Supplement: Dark chocolate Dietary Supplement: White chocolate Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : July 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in diastolic blood pressure [ Time Frame: Baseline and 12 weeks ]
    Measurement of the diastolic blood pressure with the ambulatory blood pressure monitoring


Secondary Outcome Measures :
  1. Change in systolic blood pressure [ Time Frame: Baseline and 12 weeks ]
    Measurement of the systolic blood pressure with the ambulatory blood pressure monitoring

  2. Change in total cholesterol [ Time Frame: Baseline and 12 weeks ]
  3. Change in low density lipoprotein cholesterol [ Time Frame: Baseline and 12 weeks ]
  4. Change in high density lipoprotein cholesterol [ Time Frame: Baseline and 12 weeks ]
  5. Change in triglycerides levels [ Time Frame: Baseline and 12 weeks ]
  6. Change in hs-CRP [ Time Frame: Baseline and 12 weeks ]
  7. Change in IL-1 beta levels [ Time Frame: Baseline and 12 weeks ]
  8. Change in IL-2 levels [ Time Frame: Baseline and 12 weeks ]
  9. Change in tumor necrosis factor alpha levels [ Time Frame: Baseline and 12 weeks ]
  10. Change in flow mediated dilatation of the brachial artery [ Time Frame: Baseline and 12 weeks ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01496235


Locations
Layout table for location information
Colombia
Sede Investigaciones Universitarias, Universidad de Antioquia
Medellín, Antioquia, Colombia
Sponsors and Collaborators
Universidad de Antioquia
Investigators
Layout table for investigator information
Principal Investigator: Monica L Giraldo, PhD Universidad de Antioquia
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Monica Lucia Giraldo, Principal Investigator, Universidad de Antioquia
ClinicalTrials.gov Identifier: NCT01496235    
Other Study ID Numbers: Cacao I
First Posted: December 21, 2011    Key Record Dates
Last Update Posted: December 21, 2011
Last Verified: December 2011
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases