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

Not Applicable

• Conditions: Hypertension
• Interventions: Dietary Supplement: milk powder; Dietary Supplement: Whole soy (soy flour); Dietary Supplement: daidzein

• Registration Number: NCT01270737
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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

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.

Study Timeline

• Status Verified: 2010-07
• Study First Submitted: 2011-01-04
• Study First Submitted QC: 2011-01-04
• Last Update Submitted: 2011-01-04
• Study First Posted: 2011-01-05
• Last Update Posted: 2011-01-05
• Study Start: 2011-03
• Primary Completion: 2012-06
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 270

Inclusion Criteria

• Postmenopausal Chinese women with prehypertension or stage 1 hypertension

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
milk powder	milk powder	-
Whole soy	Whole soy (soy flour)	-
daidzein	daidzein	-

Primary Outcome Measures

Name	Time	Method
24 hours blood pressure	1 year	24 hour ambulatory blood pressure recording

Secondary Outcome Measures

Name	Time	Method
Cardiovascular Disease (CVD) risks	1 year

Trial Locations

Locations (1)

Center of Research and Promotion of Women's Health; 🇨🇳 Hong Kong, China