Whole Soy and Daidzein on Reduction of Blood Pressure in Postmenopausal Chinese Women
Recruitment status was Not yet recruiting
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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 |
- 24 hours blood pressure [ Time Frame: 1 year ] [ Designated as safety issue: No ]24 hour ambulatory blood pressure recording
- 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 |
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| Contact: Suzanne C Ho, PhD | 852-22528775 | suzanneho@cuhk.edu.hk |
| China | |
| Center of Research and Promotion of Women's Health | Not yet recruiting |
| Hong Kong, China | |
| Principal Investigator: | Suzanne C Ho, Professor | Chinese University of Hong Kong |
More Information
No publications provided
| 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 May 16, 2013