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

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Unknown status
CT.gov ID
NCT01270737
Collaborator
(none)
270
Enrollment
1
Location
3
Arms
21.1
Duration (Months)
12.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Whole soy (soy flour)
  • Dietary Supplement: daidzein
  • Dietary Supplement: milk powder
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
270 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, 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
Study Start Date :
Mar 1, 2011
Anticipated Primary Completion Date :
Jun 1, 2012
Anticipated Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Whole soy

Dietary Supplement: Whole soy (soy flour)
40g soy flour per day for six months
Other Names:
  • soy flour

    		•
    Active Comparator: daidzein

    Dietary Supplement: daidzein
    66mg daidzein per day for six months
    Placebo Comparator: milk powder

    Dietary Supplement: milk powder
    40g low-fat dry milk per day for six months
    Other Names:
  • dry milk

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 24 hours blood pressure [1 year]

      24 hour ambulatory blood pressure recording

    Secondary Outcome Measures

    1. Cardiovascular Disease (CVD) risks [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    48 Years to 70 Years
    Sexes Eligible for Study:
    Female
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Center of Research and Promotion of Women's Health Hong Kong China

    Sponsors and Collaborators

    • Chinese University of Hong Kong

    Investigators

    • Principal Investigator: Suzanne C Ho, Professor, Chinese University of Hong Kong

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01270737
    Other Study ID Numbers:
    • CUHKGRF465810
    First Posted:
    Jan 5, 2011
    Last Update Posted:
    Jan 5, 2011
    Last Verified:
    Jul 1, 2010
    Additional relevant MeSH terms:
    Hypertension
    Daidzein

    Study Results

    No Results Posted as of Jan 5, 2011