Arterial Hypertension
Conditions
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.
Interventions
DIETARY_SUPPLEMENTDark 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_SUPPLEMENTWhite 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
Sponsors
Universidad de Antioquia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in diastolic blood pressure | Baseline and 12 weeks | Measurement of the diastolic blood pressure with the ambulatory blood pressure monitoring |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in total cholesterol | Baseline and 12 weeks | — |
| Change in low density lipoprotein cholesterol | Baseline and 12 weeks | — |
| Change in high density lipoprotein cholesterol | Baseline and 12 weeks | — |
| Change in triglycerides levels | Baseline and 12 weeks | — |
| Change in systolic blood pressure | Baseline and 12 weeks | Measurement of the systolic blood pressure with the ambulatory blood pressure monitoring |
| Change in IL-1 beta levels | Baseline and 12 weeks | — |
| Change in IL-2 levels | Baseline and 12 weeks | — |
| Change in tumor necrosis factor alpha levels | Baseline and 12 weeks | — |
| Change in flow mediated dilatation of the brachial artery | Baseline and 12 weeks | — |
| Change in hs-CRP | Baseline and 12 weeks | — |
Countries
Colombia
Outcome results
None listed