Equol Supplementation on Blood Pressure and Vascular Function
NCT ID: NCT02515682
Last Updated: 2015-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
207 participants
INTERVENTIONAL
2015-10-31
2018-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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High equol
High equol group will be given natural S-equol supplementation 20mg per day for 24 week.
High equol group
Participants will be give natural S-equol 20mg/d for 24 weeks.
Low equol
Low equol group will be given natural S-equol supplementation 10mg/d (+10mg starch) for 24 weeks
Low equol group
Participants will be give natural S-equol 10mg/d for 24 weeks.
Placebo
Placebo group will be given placebo control (made from starch) 20 mg per day for 24 weeks.
Placebo
Participants will be give placebo for 24 weeks.
Interventions
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High equol group
Participants will be give natural S-equol 20mg/d for 24 weeks.
Low equol group
Participants will be give natural S-equol 10mg/d for 24 weeks.
Placebo
Participants will be give placebo for 24 weeks.
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
48 Years
65 Years
FEMALE
Yes
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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Liu Zhaomin
Research Assistant Professor
References
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Liu ZM, Ho SC, Chen YM, Xie YJ, Huang ZG, Ling WH. Research protocol: effect of natural S-equol on blood pressure and vascular function--a six-month randomized controlled trial among equol non-producers of postmenopausal women with prehypertension or untreated stage 1 hypertension. BMC Complement Altern Med. 2016 Mar 1;16:89. doi: 10.1186/s12906-016-1065-5.
Other Identifiers
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CRE-2013.119-T
Identifier Type: OTHER
Identifier Source: secondary_id
471213
Identifier Type: -
Identifier Source: org_study_id
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