Effect of Cocoa Consumption in Cardiovascular and Immune Parameters

This study has been terminated.
(Difficulties with the patient recruitment)
Sponsor:
Information provided by (Responsible Party):
Monica Lucia Giraldo, Universidad de Antioquia
ClinicalTrials.gov Identifier:
NCT01496235
First received: November 24, 2011
Last updated: December 16, 2011
Last verified: December 2011

November 24, 2011
December 16, 2011
July 2009
July 2011   (final data collection date for primary outcome measure)
Change in diastolic blood pressure [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Measurement of the diastolic blood pressure with the ambulatory blood pressure monitoring
Same as current
Complete list of historical versions of study NCT01496235 on ClinicalTrials.gov Archive Site
  • Change in systolic blood pressure [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Measurement of the systolic blood pressure with the ambulatory blood pressure monitoring
  • Change in total cholesterol [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Change in low density lipoprotein cholesterol [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Change in high density lipoprotein cholesterol [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Change in triglycerides levels [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Change in hs-CRP [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Change in IL-1 beta levels [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Change in IL-2 levels [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Change in tumor necrosis factor alpha levels [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Change in flow mediated dilatation of the brachial artery [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Cocoa Consumption in Cardiovascular and Immune Parameters
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Arterial Hypertension
  • 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
  • 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
  • Active Comparator: Dark chocolate
    Presence of 70% cocoa solids
    Intervention: Dietary Supplement: Dark chocolate
  • Placebo Comparator: White chocolate
    Intervention: Dietary Supplement: White chocolate

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
69
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Colombia
 
NCT01496235
Cacao I
Yes
Monica Lucia Giraldo, Universidad de Antioquia
Universidad de Antioquia
Not Provided
Principal Investigator: Monica L Giraldo, PhD Universidad de Antioquia
Universidad de Antioquia
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP