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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01270737
Enrollment
270
Registered
2011-01-05
Start date
2011-03-31
Completion date
2012-12-31
Last updated
2011-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

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.

Interventions

DIETARY_SUPPLEMENTWhole soy (soy flour)

40g soy flour per day for six months

DIETARY_SUPPLEMENTdaidzein

66mg daidzein per day for six months

DIETARY_SUPPLEMENTmilk powder

40g low-fat dry milk per day for six months

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
48 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
24 hours blood pressure1 year24 hour ambulatory blood pressure recording

Secondary

MeasureTime frame
Cardiovascular Disease (CVD) risks1 year

Countries

China

Contacts

Primary ContactSuzanne C Ho, PhD
suzanneho@cuhk.edu.hk852-22528775

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026