Controlled Clinical Trial of the Effect of Cocoa Consumption in Lowering Blood Pressure and in the Modulation of Endothelial Inflammation in Hypertensive Patients Assigned to an Entity Health Promoting.
N/A
18 Years
65 Years
18 Years
65 Years
Open (Enrolling)
Both
Hypertension
Both
Hypertension
Trial Information
Controlled Clinical Trial of the Effect of Cocoa Consumption in Lowering Blood Pressure and in the Modulation of Endothelial Inflammation in Hypertensive Patients Assigned to an Entity Health Promoting.
Inclusion Criteria:
- Male
- Age: 18 - 65 years old
- Resides in Medellín City
- Attached from the contributive regimen of Colombian Health System
- Essential Arterial Hypertension, stage I or II.
- Be receiving pharmacologic therapy (maximum 2 medications), whose dose has been
stable for eight weeks prior to study entry.
- Voluntary desire to consume 6,5; 12; 25 or 50 grams of chocolate per day for 18
weeks.
- Voluntary desire to participate in the trial and sign informed consent.
Exclusion Criteria:
- Secondary hypertension
- Injury in target organ: heart, kidney, brain and retina
- 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 and multivitamins
- During the study excluded any participant to present a sudden increase in blood
pressure: SBP greater than or equal to 180 mmHg and/or DBP greater or equal to 110 mm
Hg.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
Change on blood pressure in patients with stage I-II hypertension, after consumption of different doses of cocoa.
Outcome Time Frame:
18 weeks
Safety Issue:
No
Principal Investigator
Mónica L. Giraldo Restrepo, Nurse. PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Universidad de Antioquia
Authority:
National Institutes of Health: Colombia
Study ID:
Cacao III
NCT ID:
NCT01276951
Start Date:
December 2008
Completion Date:
March 2011
Related Keywords:
- Hypertension
- Cocoa
- Chocolate
- Endothelial disfunction
- Cardiovascular disease
- Blood Pressure
- Hypertension
- Hypertension
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