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临床试验/NCT03510221
NCT03510221已完成不适用

Effects of Supplementation of Fruit Extract (Cranberry, Blueberry and Pomegranate) on Blood Pressure, Autonomic Balance, Insulin Resistance and Oxidative Stress in Hypertensive Patients

University of Sao Paulo General Hospital0 个研究点目标入组 54 人开始时间: 2016年1月最近更新:
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
54
主要终点
Effect of antioxidants on heart rate variability in 29 normotensive subjects and 30 hypertensive patients

研究概览

简要总结

Recent evidence suggests that there is a directly proportional relationship between diets with a high concentration of antioxidants and the reduction of blood pressure and the risk of cardiovascular events. However, there is a gap with regard to research on the effects of these diets on vascular function, especially in humans. The aim of this study was to evaluate the effect of antioxidant supplementation through the consumption of blueberry, cranberry and pomegranate extract capsules (1 of each per day), the effect of the autonomic balance in hypertensive and normotensive adults.

详细描述

A clinical trial was performed, with 60 individuals, 30 normotensive and 30 hypertensive patients. Participants were of both sex, aged between 18 and 60 years and Body Mass Index (BMI) less than 35 kg / m². Venous blood samples were collected after 12-hour fasting for biochemical measurements (glucose, total cholesterol and LDL-cholesterol, HDL-cholesterol, triglycerides, uric acid, sodium, potassium, urea, creatinine, insulin), and adiponectin , interleukin-4 (IL-4), interleukin-2β (IL-2β), monocyte chemoattractant protein-1 (MCP-1), leptin, C-reactive protein, tumor necrosis factor alpha (TNF-α), interleukin-6 and nitrotyrosine. An anthropometric evaluation was performed with measures of weight, height, waist circumference and cervical circumference. The hemodynamic evaluation was done through a non-invasive monitor. The study participants were divided into 2 different groups: Group A (normotensive) and Group B (hypertensive). The capsules for antioxidant supplementation were of blueberry, cranberry and pomegranate, being one capsule of each a day. Study participants received placebo capsules for 4 weeks and then received the fruit extract capsules (blueberry, cranberry and pomegranate), one capsule a day for 4 weeks. All tests were performed at baseline, after 4 and 8 weeks of intervention. The comparison between groups was performed with the Multiple Comparison Test (ANOVA). The research project was approved by the Ethics Committee for Analysis of Research Projects (CAPPesq) of the Hospital das Clinicas of the Faculty of Medicine of the University of Sao Paulo. Participation in the research was voluntary and all participants read and signed the consent form. The risk for the present participant was minimal.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of hypertension - group Hypertensives
  • Healthy people - group Normotensive

排除标准

  • Patients with glycated hemoglobin > 7%,
  • Patients with a diagnosis of cardiovascular disease,
  • Patients with LDL-cholesterol> 160 mg/dL (non-diabetics)
  • Pregnant women,
  • Cigarret smokers,
  • Diabetics using more than one drug in addition to metformin,
  • Patients with LDL-cholesterol> 130 mg/dL (non-diabetic using statin),
  • LDL cholesterol ≥ 100 mg / dL (patients on statin),
  • Patients with valvular heart disease,
  • Pulmonary hypertension,
  • Patients with collagen disease,
  • Patients with type of cancer,
  • Complex arrhythmia,
  • Those patients with any chronic crippling pathology.

研究组 & 干预措施

Antioxidants

Active Comparator

Subjects received 3 antioxidant capsules (1 capsule of blueberry + 1 capsule of cranberry + 1 capsule pomegranate - a day) during 4 weeks.

干预措施: Antioxidants capsules (Dietary Supplement)

Placebo

Placebo Comparator

Subjects received 3 placebo capsules during 4 weeks.

干预措施: Antioxidants capsules (Dietary Supplement)

结局指标

主要结局

Effect of antioxidants on heart rate variability in 29 normotensive subjects and 30 hypertensive patients

时间窗: 4 weeks

Antioxidant supplementation should improve heart rate variability as a consequence of improved antioxidant capacity

次要结局

  • Effect of antioxidants on insulin resistance in 29 normotensive subjects and 30 hypertensive patients(4 weeks)
  • Effect of antioxidants on blood pressure in 29 normotensive subjects and 30 hypertensive patients(4 weeks)
  • Effect of antioxidants on antioxidant capacity in 29 normotensive subjects and 30 hypertensive patients(4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

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