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临床试验/NCT02515682
NCT02515682Unknown不适用

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

Chinese University of Hong Kong0 个研究点目标入组 207 人开始时间: 2015年10月最近更新:
适应症

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

  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.

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

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.

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Liu Zhaomin

Research Assistant Professor

Chinese University of Hong Kong

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