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临床试验/NCT01276951
NCT01276951已完成不适用

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.

Universidad de Antioquia1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2008年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
125
试验地点
1
主要终点
Change on blood pressure in patients with stage I-II hypertension, after consumption of different doses of cocoa.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Placebo

Placebo Comparator

干预措施: Delivery and return of chocolate (Dietary Supplement)

Placebo

Placebo Comparator

干预措施: Determination of blood pressure (Procedure)

Placebo

Placebo Comparator

干预措施: Anthropometric Measurements (Procedure)

Placebo

Placebo Comparator

干预措施: Food Anamnesis (Procedure)

Placebo

Placebo Comparator

干预措施: Samples: serological tests and culture of mononuclear cells (Procedure)

12g Dose Group

Active Comparator

干预措施: Anthropometric Measurements (Procedure)

Placebo

Placebo Comparator

干预措施: Analysis of cytokine production (Procedure)

6,5g Dose Group

Active Comparator

干预措施: Anthropometric Measurements (Procedure)

6,5g Dose Group

Active Comparator

干预措施: Delivery and return of chocolate (Dietary Supplement)

6,5g Dose Group

Active Comparator

干预措施: Determination of blood pressure (Procedure)

6,5g Dose Group

Active Comparator

干预措施: Food Anamnesis (Procedure)

6,5g Dose Group

Active Comparator

干预措施: Samples: serological tests and culture of mononuclear cells (Procedure)

6,5g Dose Group

Active Comparator

干预措施: Analysis of cytokine production (Procedure)

12g Dose Group

Active Comparator

干预措施: Delivery and return of chocolate (Dietary Supplement)

12g Dose Group

Active Comparator

干预措施: Determination of blood pressure (Procedure)

12g Dose Group

Active Comparator

干预措施: Food Anamnesis (Procedure)

12g Dose Group

Active Comparator

干预措施: Samples: serological tests and culture of mononuclear cells (Procedure)

12g Dose Group

Active Comparator

干预措施: Analysis of cytokine production (Procedure)

25g Dose Group

Active Comparator

干预措施: Anthropometric Measurements (Procedure)

25g Dose Group

Active Comparator

干预措施: Delivery and return of chocolate (Dietary Supplement)

25g Dose Group

Active Comparator

干预措施: Determination of blood pressure (Procedure)

25g Dose Group

Active Comparator

干预措施: Food Anamnesis (Procedure)

25g Dose Group

Active Comparator

干预措施: Samples: serological tests and culture of mononuclear cells (Procedure)

25g Dose Group

Active Comparator

干预措施: Analysis of cytokine production (Procedure)

50g Dose Group

Active Comparator

干预措施: Anthropometric Measurements (Procedure)

50g Dose Group

Active Comparator

干预措施: Delivery and return of chocolate (Dietary Supplement)

50g Dose Group

Active Comparator

干预措施: Determination of blood pressure (Procedure)

50g Dose Group

Active Comparator

干预措施: Food Anamnesis (Procedure)

50g Dose Group

Active Comparator

干预措施: Samples: serological tests and culture of mononuclear cells (Procedure)

50g Dose Group

Active Comparator

干预措施: Analysis of cytokine production (Procedure)

结局指标

主要结局

Change on blood pressure in patients with stage I-II hypertension, after consumption of different doses of cocoa.

时间窗: 18 weeks

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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