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Clinical Trials/NCT01270737
NCT01270737
Unknown
Not Applicable

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 site in 1 country270 target enrollmentMarch 2011
ConditionsHypertension

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
Chinese University of Hong Kong
Enrollment
270
Locations
1
Primary Endpoint
24 hours blood pressure
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2011
End Date
December 2012
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

24 hours blood pressure

Time Frame: 1 year

24 hour ambulatory blood pressure recording

Secondary Outcomes

  • Cardiovascular Disease (CVD) risks(1 year)

Study Sites (1)

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