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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01270737
• Other study ID #: CUHKGRF465810
• Status: Not yet recruiting
• Phase: N/A
• First received: January 4, 2011
• Last updated: January 4, 2011
• Start date: March 2011
• Est. completion date: December 2012

Study information

• Verified date: July 2010
• Source: Chinese University of Hong Kong
• Contact: Suzanne C Ho, PhD
• Phone: 852-22528775
• Email: suzanneho[@]cuhk.edu.hk
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 270
• Est. completion date: December 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 48 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypertension

Intervention

Dietary Supplement:
• Whole soy (soy flour)
40g soy flour per day for six months
• daidzein
66mg daidzein per day for six months
• milk powder
40g low-fat dry milk per day for six months

Locations

Country	Name	City	State
China	Center of Research and Promotion of Women's Health	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 hours blood pressure	24 hour ambulatory blood pressure recording	1 year	No
Secondary	Cardiovascular Disease (CVD) risks		1 year	No