Equol Supplementation on Blood Pressure and Vascular Function
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|ClinicalTrials.gov Identifier: NCT02515682|
Recruitment Status : Not yet recruiting
First Posted : August 5, 2015
Last Update Posted : August 5, 2015
Chinese University of Hong Kong
Information provided by (Responsible Party):
Liu Zhaomin, Chinese University of Hong Kong
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.
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Dietary Supplement: High equol group Dietary Supplement: Low equol group Dietary Supplement: Placebo||Not Applicable|
- 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).
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||207 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||December 2018|
Active Comparator: High equol
High equol group will be given natural S-equol supplementation 20mg per day for 24 week.
Dietary Supplement: High equol group
Participants will be give natural S-equol 20mg/d for 24 weeks.
Active Comparator: Low equol
Low equol group will be given natural S-equol supplementation 10mg/d (+10mg starch) for 24 weeks
Dietary Supplement: Low equol group
Participants will be give natural S-equol 10mg/d for 24 weeks.
Placebo Comparator: Placebo
Placebo group will be given placebo control (made from starch) 20 mg per day for 24 weeks.
Dietary Supplement: Placebo
Participants will be give placebo for 24 weeks.
Primary Outcome Measures :
- Ambulatory blood pressure [ Time Frame: 24 weeks ]
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