Equol Supplementation on Blood Pressure and Vascular Function

Not Applicable

• Conditions: Hypertension
• Interventions: Dietary Supplement: High equol group; Dietary Supplement: Low equol group; Dietary Supplement: Placebo

• Registration Number: NCT02515682
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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

Inclusion criteria

1. Hong Kong Chinese women aged 45-65 y with 2\~8 years menopausal;

2. 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.

3. 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

1. Subjects on anti-hypertensive medication or with average SBP≥160 or DBP≥100 or both;

2. Use of medications known to affect BP within past 6 months;

3. Medical history or presence of certain chronic diseases that could affect BP or limit the individual's ability to participate in the study;

4. Present or history of certain cancers;

5. Regular smoker or alcohol consumption more than 30 g/day;

6. Known soy allergy.

Study Timeline

• Study First Submitted: 2015-07-31
• Status Verified: 2015-08
• Study First Submitted QC: 2015-08-03
• Last Update Submitted: 2015-08-03
• Study First Posted: 2015-08-05
• Last Update Posted: 2015-08-05
• Study Start: 2015-10
• Primary Completion: 2018-07
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 207

Inclusion Criteria

1. Hong Kong Chinese women aged 45-65 y with 2~8 years menopausal;
2. 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.
3. 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).
4. Written informed consent will be obtained from all the participants prior to enrolment.

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Exclusion Criteria

1. Subjects on anti-hypertensive medication or with average SBP≥160 or DBP≥100 or both;
2. use of medications known to affect BP within past 6 months (hormone therapy, hypoglycemic or weight reduction agents);
3. 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;
4. present or history of breast cancer, endometrial cancer, ovarian cancer, thyroid disorder, abnormal uterine bleeding after menopause;
5. regular smoker or alcohol consumption more than 30 g/day;
6. known soy allergy.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High equol	High equol group	High equol group will be given natural S-equol supplementation 20mg per day for 24 week.
Low equol	Low equol group	Low equol group will be given natural S-equol supplementation 10mg/d (+10mg starch) for 24 weeks
Placebo	Placebo	Placebo group will be given placebo control (made from starch) 20 mg per day for 24 weeks.

Primary Outcome Measures

Name	Time	Method
Ambulatory blood pressure	24 weeks