Randomized Clinical Trial of the Effect of Cocoa Consumption in Cardiovascular and Immune Parameters in Colombian Patients With Newly Diagnosed Stage 1 Arterial Hypertension
N/A
18 Years
65 Years
18 Years
65 Years
Not Enrolling
Both
Arterial Hypertension
Both
Arterial Hypertension
Trial Information
Randomized Clinical Trial of the Effect of Cocoa Consumption in Cardiovascular and Immune Parameters in Colombian Patients With Newly Diagnosed Stage 1 Arterial Hypertension
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Change in diastolic blood pressure
Outcome Description:
Measurement of the diastolic blood pressure with the ambulatory blood pressure monitoring
Outcome Time Frame:
Baseline and 12 weeks
Safety Issue:
No
Principal Investigator
Monica L Giraldo, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Universidad de Antioquia
Authority:
Colombia: National Institutes of Health
Study ID:
Cacao I
NCT ID:
NCT01496235
Start Date:
July 2009
Completion Date:
July 2011
Related Keywords:
- Arterial Hypertension
- Hypertension
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