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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Chinese University of Hong Kong.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01270737
First received: January 4, 2011
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

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


Condition Intervention
Hypertension
Dietary Supplement: Whole soy (soy flour)
Dietary Supplement: daidzein
Dietary Supplement: milk powder

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Double-blind Randomized Controlled Trial on Whole Soy and Daidzein Supplementation on Reduction of Blood Pressure in Prehypertensive Postmenopausal Chinese Women

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • 24 hours blood pressure [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    24 hour ambulatory blood pressure recording


Secondary Outcome Measures:
  • Cardiovascular Disease (CVD) risks [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 270
Study Start Date: March 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Whole soy Dietary Supplement: Whole soy (soy flour)
40g soy flour per day for six months
Other Name: soy flour
Active Comparator: daidzein Dietary Supplement: daidzein
66mg daidzein per day for six months
Other Name: daidzein
Placebo Comparator: milk powder Dietary Supplement: milk powder
40g low-fat dry milk per day for six months
Other Name: dry milk

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.

  Eligibility

Ages Eligible for Study:   48 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01270737

Contacts
Contact: Suzanne C Ho, PhD 852-22528775 suzanneho@cuhk.edu.hk

Locations
China
Center of Research and Promotion of Women's Health Not yet recruiting
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Suzanne C Ho, Professor Chinese University of Hong Kong
  More Information

No publications provided by Chinese University of Hong Kong

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Suzanne C Ho, director of Center of Research and Promotion of Women's Health, CRPWH
ClinicalTrials.gov Identifier: NCT01270737     History of Changes
Other Study ID Numbers: CUHKGRF465810
Study First Received: January 4, 2011
Last Updated: January 4, 2011
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Daidzein
Phytoestrogens
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014