Controlled Clinical Trial to Determine the Effective Dose of Cocoa in Lowering Blood Pressure
- Conditions
- Hypertension
- Interventions
- Dietary Supplement: Delivery and return of chocolateProcedure: Determination of blood pressureProcedure: Anthropometric MeasurementsProcedure: Food AnamnesisProcedure: Analysis of cytokine production
- Registration Number
- NCT01276951
- Lead Sponsor
- Universidad de Antioquia
- Brief Summary
In Colombia, ischemic heart disease and stroke are one of the most important causes of death in 45 years old people. Care of cases of disease represents high costs for the health system in particular and society in general, due to the loss of productive years life and costs for the care of the aftermath. Hypertension (HT) is one of the preventable risk factors for major cerebrovascular disorders. The pathophysiology of Essential hypertension is complex and depends of interaction of genetic and environmental factors. Among the determining elements are the increase in the activity of the sympathetic nervous system, the vasoconstricting and overproduction of hormones associated with sodium retention, disruption in renin secretion with increased production of aldosterone and angiotensin II, the deregulation of the kinins system, the increase in peripheral vascular resistance and activity of Growth factors in atherogenesis and vascular endothelial dysfunction, increased cardiac output, diabetes mellitus, obesity, and lower production of vasodilators such as brain natriuretic peptide (BNP), the prostacyclins and nitric oxide (NO), among others.
Cocoa is a food rich in flavonoids, which stimulate the enzyme activity of endothelial nitric oxide synthase (e-NOS), responsible of the production of NO in vascular smooth muscle. The flavonoids modulate the synthesis of inflammatory substances that are derived from endothelial cells and the immune system.
In a recent study found that with a few grams of cocoa achieves a significant reduction in blood pressure, so the investigators propose a controlled clinical trial to assess the effect of different doses of cocoa on blood pressure and endothelial inflammation in men with essential hypertension, stage I-II without target organ damage, in addition to pharmacologic monotherapy defined for the management of their disease. The investigators hope to determine an optimal dose of cocoa, with long-term effects, by their high content of flavonoids, improves cardiovascular and endothelial parameters with the advantage that it is an economical and easy introduction into the patient's habits.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 125
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 6,5g Dose Group Anthropometric Measurements - 6,5g Dose Group Food Anamnesis - 12g Dose Group Anthropometric Measurements - 50g Dose Group Anthropometric Measurements - Placebo Food Anamnesis - 25g Dose Group Analysis of cytokine production - 50g Dose Group Delivery and return of chocolate - Placebo Determination of blood pressure - 6,5g Dose Group Analysis of cytokine production - 12g Dose Group Determination of blood pressure - 12g Dose Group Food Anamnesis - 25g Dose Group Food Anamnesis - Placebo Delivery and return of chocolate - Placebo Anthropometric Measurements - Placebo Analysis of cytokine production - 6,5g Dose Group Delivery and return of chocolate - 6,5g Dose Group Determination of blood pressure - 12g Dose Group Analysis of cytokine production - 25g Dose Group Delivery and return of chocolate - 25g Dose Group Determination of blood pressure - 50g Dose Group Determination of blood pressure - 50g Dose Group Food Anamnesis - 12g Dose Group Delivery and return of chocolate - 25g Dose Group Anthropometric Measurements - 50g Dose Group Analysis of cytokine production -
- Primary Outcome Measures
Name Time Method Change on blood pressure in patients with stage I-II hypertension, after consumption of different doses of cocoa. 18 weeks
- Secondary Outcome Measures
Name Time Method Change in the oxidation of low density lipoproteins after cocoa consumption, in patients with stage I-II hypertension. 18 weeks Change in the production of inflammatory molecules derived from peripheral blood mononuclear cells of patients with arterial hypertension stage I-II, after cocoa consumption. 18 weeks Change in platelet aggregation after cocoa consumption, in patients with essential arterial hypertension stage I-II. 18 weeks
Trial Locations
- Locations (1)
Sede Investigaciones Universitarias, Universidad de Antioquia
🇨🇴Medellín, Antioquia, Colombia