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
试验速览
- 阶段
- 不适用
- 入组人数
- 207
- 主要终点
- Ambulatory blood pressure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 48 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
High equol
High equol group will be given natural S-equol supplementation 20mg per day for 24 week.
干预措施: High equol group (Dietary Supplement)
Low equol
Low equol group will be given natural S-equol supplementation 10mg/d (+10mg starch) for 24 weeks
干预措施: Low equol group (Dietary Supplement)
Placebo
Placebo group will be given placebo control (made from starch) 20 mg per day for 24 weeks.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Ambulatory blood pressure
时间窗: 24 weeks
次要结局
未报告次要终点
研究者
Liu Zhaomin
Research Assistant Professor
Chinese University of Hong Kong