NCT01270737

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
270

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 5, 2011

Status Verified

July 1, 2010

Enrollment Period

1.3 years

First QC Date

January 4, 2011

Last Update Submit

January 4, 2011

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • 24 hours blood pressure

    24 hour ambulatory blood pressure recording

    1 year

Secondary Outcomes (1)

  • Cardiovascular Disease (CVD) risks

    1 year

Study Arms (3)

Whole soy

ACTIVE COMPARATOR
Dietary Supplement: Whole soy (soy flour)

daidzein

ACTIVE COMPARATOR
Dietary Supplement: daidzein

milk powder

PLACEBO COMPARATOR
Dietary Supplement: milk powder

Interventions

Whole soy (soy flour)DIETARY_SUPPLEMENT

40g soy flour per day for six months

Also known as: soy flour
Whole soy
daidzeinDIETARY_SUPPLEMENT

66mg daidzein per day for six months

daidzein
milk powderDIETARY_SUPPLEMENT

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

Also known as: dry milk
milk powder

Eligibility Criteria

Age48 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal Chinese women with prehypertension or stage 1 hypertension

You may not qualify if:

  • Medical treatment for blood pressure or lipids reduction hormones replacement therapy in recent 3 months, chronic renal or hepatic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center of Research and Promotion of Women's Health

Hong Kong, China

Location

Related Publications (8)

  • 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.

    PMID: 32595918DERIVED

  • 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.

    PMID: 31914834DERIVED

  • 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.

    PMID: 25782428DERIVED

  • 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.

    PMID: 24877660DERIVED

  • 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.

    PMID: 24659208DERIVED

  • 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.

    PMID: 24273218DERIVED

  • 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.

    PMID: 24149925DERIVED

  • 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.

    PMID: 23984051DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

daidzeinRefit milk powder

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Suzanne C Ho, Professor

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Suzanne C Ho, PhD

CONTACT

852-22528775suzanneho@cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 4, 2011

First Posted

January 5, 2011

Study Start

March 1, 2011

Primary Completion

June 1, 2012

Study Completion

December 1, 2012

Last Updated

January 5, 2011

Record last verified: 2010-07

Locations

CN(1)