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

Primary Purpose

Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Whole soy (soy flour)
daidzein
milk powder
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension

Eligibility Criteria

48 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Center of Research and Promotion of Women's Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Whole soy

daidzein

milk powder

Arm Description

Outcomes

Primary Outcome Measures

24 hours blood pressure
24 hour ambulatory blood pressure recording

Secondary Outcome Measures

Cardiovascular Disease (CVD) risks

Full Information

First Posted
January 4, 2011
Last Updated
January 4, 2011
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT01270737
Brief Title
Whole Soy and Daidzein on Reduction of Blood Pressure in Postmenopausal Chinese Women
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 Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Whole soy
Arm Type
Active Comparator
Arm Title
daidzein
Arm Type
Active Comparator
Arm Title
milk powder
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Whole soy (soy flour)
Other Intervention Name(s)
soy flour
Intervention Description
40g soy flour per day for six months
Intervention Type
Dietary Supplement
Intervention Name(s)
daidzein
Intervention Description
66mg daidzein per day for six months
Intervention Type
Dietary Supplement
Intervention Name(s)
milk powder
Other Intervention Name(s)
dry milk
Intervention Description
40g low-fat dry milk per day for six months
Primary Outcome Measure Information:
Title
24 hours blood pressure
Description
24 hour ambulatory blood pressure recording
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Cardiovascular Disease (CVD) risks
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
48 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suzanne C Ho, PhD
Phone
852-22528775
Email
suzanneho@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne C Ho, Professor
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center of Research and Promotion of Women's Health
City
Hong Kong
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
32595918
Citation
Liu ZM, Chen B, Li S, Li G, Zhang D, Ho SC, Chen YM, Ma J, Qi H, Ling WH. Effect of whole soy and isoflavones daidzein on bone turnover and inflammatory markers: a 6-month double-blind, randomized controlled trial in Chinese postmenopausal women who are equol producers. Ther Adv Endocrinol Metab. 2020 Jun 18;11:2042018820920555. doi: 10.1177/2042018820920555. eCollection 2020.
Results Reference
derived
PubMed Identifier
31914834
Citation
Liu ZM, Li G, Zhang D, Ho SC, Chen YM, Ma J, Huang Q, Li S, Ling WH. Effect of whole soy and purified daidzein on androgenic hormones in chinese equol-producing post-menopausal women: a six-month randomised, double-blinded and Placebo-Controlled trial. Int J Food Sci Nutr. 2020 Aug;71(5):644-652. doi: 10.1080/09637486.2020.1712682. Epub 2020 Jan 9.
Results Reference
derived
PubMed Identifier
25782428
Citation
Liu ZM, Ho SC, Chen YM, Tomlinson B, Ho S, To K, Woo J. Effect of whole soy and purified daidzein on ambulatory blood pressure and endothelial function--a 6-month double-blind, randomized controlled trial among Chinese postmenopausal women with prehypertension. Eur J Clin Nutr. 2015 Oct;69(10):1161-8. doi: 10.1038/ejcn.2015.24. Epub 2015 Mar 18.
Results Reference
derived
PubMed Identifier
24877660
Citation
Liu ZM, Ho SC, Chen YM, Tang N, Woo J. Effect of whole soy and purified isoflavone daidzein on renal function--a 6-month randomized controlled trial in equol-producing postmenopausal women with prehypertension. Clin Biochem. 2014 Sep;47(13-14):1250-6. doi: 10.1016/j.clinbiochem.2014.05.054. Epub 2014 May 27.
Results Reference
derived
PubMed Identifier
24659208
Citation
Liu ZM, Ho CS, Chen YM, Woo J. Can soy intake affect serum uric acid level? Pooled analysis from two 6-month randomized controlled trials among Chinese postmenopausal women with prediabetes or prehypertension. Eur J Nutr. 2015 Feb;54(1):51-8. doi: 10.1007/s00394-014-0684-1.
Results Reference
derived
PubMed Identifier
24273218
Citation
Liu ZM, Ho SC, Chen YM, Ho S, To K, Tomlinson B, Woo J. Whole soy, but not purified daidzein, had a favorable effect on improvement of cardiovascular risks: a 6-month randomized, double-blind, and placebo-controlled trial in equol-producing postmenopausal women. Mol Nutr Food Res. 2014 Apr;58(4):709-17. doi: 10.1002/mnfr.201300499. Epub 2013 Nov 24.
Results Reference
derived
PubMed Identifier
24149925
Citation
Liu ZM, Ho SC, Woo J, Chen YM, Wong C. Randomized controlled trial of whole soy and isoflavone daidzein on menopausal symptoms in equol-producing Chinese postmenopausal women. Menopause. 2014 Jun;21(6):653-60. doi: 10.1097/GME.0000000000000102.
Results Reference
derived
PubMed Identifier
23984051
Citation
Liu ZM, Ho SC, Chen YM, Woo J. A six-month randomized controlled trial of whole soy and isoflavones daidzein on body composition in equol-producing postmenopausal women with prehypertension. J Obes. 2013;2013:359763. doi: 10.1155/2013/359763. Epub 2013 Aug 1.
Results Reference
derived

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

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