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临床试验/NCT01270737
NCT01270737Unknown不适用

A Double-blind Randomized Controlled Trial on Whole Soy and Daidzein Supplementation on Reduction of Blood Pressure in Prehypertensive Postmenopausal Chinese Women

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2011年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
270
试验地点
1
主要终点
24 hours blood pressure

研究概览

简要总结

The investigators hypothesize that whole soy or purified daidzein alone could reduce blood pressure and CVD risks in equol-producing menopausal Chinese women.

详细描述

Hypertension is an important risk factor for cardiovascular diseases. Substantial evidence has also shown that prehypertension [systolic blood pressure (BP) 120-139 mm Hg or diastolic BP 80-89 mm Hg] is the strongest predictor of incident hypertension and is associated with elevated risk of cardiovascular diseases. Thus, prehypertension and its progression to hypertension have enormous public health implications. Soybean contains many beneficial components, among which isoflavones have received most research attention. Recently researchers have investigated their influences on vascular functions but only a handful of studies have focused on BP reduction as the primary outcome.The role of whole soy or daidzein on BP is yet unclear.

The investigators hypothesize that whole soy (soy flour) or purified daidzein alone could reduce BP,and decrease CVD risks in menopausal women with prehypertension or initial untreated hypertension. The investigators propose to perform a 24-week double-blind, randomized, placebo-controlled trial in postmenopausal women with prehypertension or stage 1 hypertension. The primary objective is to verify if whole soy (soy flour) or purified daidzein alone has anti-hypertensive effects at a dosage of habitual high soy intake.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
48 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Postmenopausal Chinese women with prehypertension or stage 1 hypertension

排除标准

  • Medical treatment for blood pressure or lipids reduction hormones replacement therapy in recent 3 months, chronic renal or hepatic diseases

结局指标

主要结局

24 hours blood pressure

时间窗: 1 year

24 hour ambulatory blood pressure recording

次要结局

  • Cardiovascular Disease (CVD) risks(1 year)

研究者

申办方类型
Other

研究点 (1)

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