Equol Supplementation on Blood Pressure and Vascular Function

Study Overview
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Brief Summary
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We propose to perform a 24-week randomized, double-blind a placebo-controlled trial among 207 non-equol producing postmenopausal women with prehypertension to examine the effectiveness of equol (10mg and 20mg/d) on 24h ambulatory blood pressure, vascular function and other cardiovascular risks (lipid profile, glycemic control and inflammatory biomarkers) and explore the optimal dosage of equol.

Detailed Description
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Inclusion criteria Hong Kong Chinese women aged 45-65 y with 2 8 years menopausal; Mean SBP above 130 mmHg or DBP above 80 mmHg or both based on an average of 6 BP readings on two different occasions measured by sphygmomanometer. Equol non-producer is defined as 24-hour urinary log10 S-equol:daidzein ratio less than -1.75 after daidzein challenge (60mg daidzein daily for 7 consecutive days). Exclusion criteria Subjects on anti-hypertensive medication or with average SBP≥160 or DBP≥100 or both; Use of medications known to affect BP within past 6 months; Medical history or presence of certain chronic diseases that could affect BP or limit the individual's ability to participate in the study; Present or history of certain cancers; Regular smoker or alcohol consumption more than 30 g/day; Known soy allergy.

Official Title
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Effect of Natural S-equol on Blood Pressure and Vascular funtion-a Six-month Randomized, Double-blind and Placebo-controlled Trial Among Equol Non-producers of Postmenopausal Women With Prehypertension or Untreated Stage 1 Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Dietary Supplement: High equol group
* Dietary Supplement: Low equol group
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hong Kong Chinese women aged 45-65 y with 2 8 years menopausal; mean SBP above 130 mmHg or DBP above 80 mmHg or both based on an average of 6 BP readings on two different occasions measured by sphygmomanometer. Equol non-producer is defined as 24-hour urinary log10 S-equol:daidzein ratio less than -1.75 after daidzein challenge (60mg daidzein daily for 7 consecutive days). Written informed consent will be obtained from all the participants prior to enrolment. Exclusion Criteria: Subjects on anti-hypertensive medication or with average SBP≥160 or DBP≥100 or both; use of medications known to affect BP within past 6 months (hormone therapy, hypoglycemic or weight reduction agents); medical history or presence of certain chronic diseases (stroke, cardiac infarction, severe liver and renal disease etc.) that could affect BP or limit the individual's ability to participate in the study; present or history of breast cancer, endometrial cancer, ovarian cancer, thyroid disorder, abnormal uterine bleeding after menopause; regular smoker or alcohol consumption more than 30 g/day; known soy allergy.

Ages Eligible for Study
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Minimum Age: 48 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High equol<br>High equol group will be given natural S-equol supplementation 20mg per day for 24 week. | Dietary Supplement: High equol group<br>* Participants will be give natural S-equol 20mg/d for 24 weeks.<br>|
| Active Comparator: Low equol<br>Low equol group will be given natural S-equol supplementation 10mg/d (+10mg starch) for 24 weeks | Dietary Supplement: Low equol group<br>* Participants will be give natural S-equol 10mg/d for 24 weeks.<br>|
| Placebo Comparator: Placebo<br>Placebo group will be given placebo control (made from starch) 20 mg per day for 24 weeks. | Dietary Supplement: Placebo<br>* Participants will be give placebo for 24 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ambulatory blood pressure |  | 24 weeks |