Clinical trial NCT01276951: Controlled Clinical Trial to Determine the Effective Dose of Cocoa in Lowering Blood Pressure
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Cocoa
Chocolate
Endothelial disfunction
Cardiovascular disease
Blood Pressure
Hypertension
Lead sponsor: Universidad de Antioquia
Sponsor class: OTHER
Collaborators: name: Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
First posted: 2011-01-14
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change on blood pressure in patients with stage I-II hypertension, after consumption of different doses of cocoa.
timeFrame: 18 weeks
Secondary outcomes:
measure: Change in the oxidation of low density lipoproteins after cocoa consumption, in patients with stage I-II hypertension.
timeFrame: 18 weeks
measure: Change in the production of inflammatory molecules derived from peripheral blood mononuclear cells of patients with arterial hypertension stage I-II, after cocoa consumption.
timeFrame: 18 weeks
measure: Change in platelet aggregation after cocoa consumption, in patients with essential arterial hypertension stage I-II.
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Medellín
country: Colombia
facility: Sede Investigaciones Universitarias, Universidad de Antioquia
state: Antioquia
Study officials:
affiliation: Universidad de Antioquia
name: Mónica L. Giraldo Restrepo, Nurse. PhD
role: PRINCIPAL_INVESTIGATOR
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