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