Controlled Clinical Trial to Determine the Effective Dose of Cocoa in Lowering Blood Pressure
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

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.
    


Intervention name(s): Delivery and return of chocolate; Determination of blood pressure; Anthropometric Measurements; Food Anamnesis; Samples: serological tests and culture of mononuclear cells; Analysis of cytokine production
Intervention type(s): Dietary Supplement; Procedure; Procedure; Procedure; Procedure; Procedure
Intervention description(s): At baseline and then every 2 weeks, each participant will receive different grams of chocolate, according to the group to which he is assigned.; Blood pressure will be determined at study entry, ninth and eighteenth week taking into account the protocols established in 2007 by the European Society of Cardiology and Hypertension. Because blood pressure has variations throughout the day and that measuring ambulatory health institutions can generate emotional changes that induce changes in this clinical setting, which for purposes of this study is the main outcome variable, there will be 24-hour monitoring of blood pressure at the beginning and end of the study.; The study will be determined the body mass index (BMI) by the ratio of weight in kilograms over height in meters squared, for which anthropometric measurement will be made at first, ninth and the eighteenth week as follows: The weight will be taken with an electronic balance of 0.05 g sensitivity standing capacity of 150 kg. We will be rated based on BMI cut points given by WHO-PAHO (1993) and adopted by the Ministry of Health of Colombia (2000).; With the aim of learning about the eating habits, it will be made based on a food intake recall the last 24 hours, taking into account that is not preceded by a special food day (sundays, holidays, celebrations). For more accurately calculate nutrient ingested food, modules will be used.; At admission and at the end of the study will be obtained after 12 hours of fasting, 8 mL of blood in a dry tube without anticoagulant and 30 mL of blood in heparin tubes, properly labeled with the code assigned to the participant. The sample will be used to determine the complete lipid profile (triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol and VLDL cholesterol), State of oxidation of low density lipoprotein (oxLDL) and mononuclear cell culture. The remaining serum was kept at -20°C for use if is required repeat any study.; We will be used the supernatant of mononuclears cell culture to quantify the production of interleukin one beta, interleukin two, tumor necrosis factor alpha by ELISA with commercially available kits for this purpose.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Cocoa; Chocolate; Endothelial disfunction; Cardiovascular disease; Blood Pressure; Hypertension