Whole Soy and Daidzein on Reduction of Blood Pressure in Postmenopausal Chinese Women

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

Detailed Description
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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.

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

Conditions
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Hypertension

Intervention / Treatment
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* Dietary Supplement: Whole soy (soy flour)
* Dietary Supplement: daidzein
* Dietary Supplement: milk powder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postmenopausal Chinese women with prehypertension or stage 1 hypertension Exclusion Criteria: Medical treatment for blood pressure or lipids reduction hormones replacement therapy in recent 3 months, chronic renal or hepatic diseases

Ages Eligible for Study
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Minimum Age: 48 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Whole soy<br> | Dietary Supplement: Whole soy (soy flour)<br>* 40g soy flour per day for six months<br>* Other names: soy flour;|
| Active Comparator: daidzein<br> | Dietary Supplement: daidzein<br>* 66mg daidzein per day for six months<br>|
| Placebo Comparator: milk powder<br> | Dietary Supplement: milk powder<br>* 40g low-fat dry milk per day for six months<br>* Other names: dry milk;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hours blood pressure | 24 hour ambulatory blood pressure recording | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular Disease (CVD) risks |  | 1 year |