NCT04490720招募中不适用
The Efficacy Evaluation of Buckwheat Husk Extract on Cardiovascular Disease Risk Factors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change from baseline in blood pressure (systolic blood pressure, diastolic blood pressure)
研究概览
简要总结
To assess the efficacy evaluation of buckwheat husk extract on cardiovascular disease risk factors
详细描述
This is a double-blind and randomized study. Subjects are informed to consume the samples every day for 2 months. The clinical diagnosis item of cardiovascular disease is evaluated by the doctor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •20 to 65-year-old males or non-pregnant females who are willing to sign the subject's consent.
- •The systolic blood pressure is 121-139 mmHg and the diastolic blood pressure is between 81-89 mmHg.
- •Those who are not pregnant and are willing to cooperate with contraception during the trial period.
- •No history of organ transplantation, epilepsy or convulsions, liver or kidney disease, malignant tumor, endocrine disease, mental disease, alcohol or drug abuse, or other major organic diseases (according to medical history).
排除标准
- •Pregnant women.
- •People with a history of organ transplantation, epilepsy or convulsions, liver and kidney disease, malignant tumors, endocrine diseases, mental illness, alcohol or drug abuse, and other major organic diseases (according to medical history).
- •No person has undergone major surgery.
结局指标
主要结局
Change from baseline in blood pressure (systolic blood pressure, diastolic blood pressure)
时间窗: Days 1, 28, and 56
Blood pressure will be measured at the beginning, 4-week, and 8-week time points.
次要结局
- Change from baseline in blood lipid (total-Cholesterol, triglyceride, HDL-C, LDL-C)(Days 1, 28, and 56)
- Change from baseline in blood cardiovascular disease risk biomarker (hs-CRP, NO, Trimethylamine-N-oxide)(Days 1, 28, and 56)
- Change from baseline in Body Mass Index (BMI)(Days 1, 28, and 56)
- Change from baseline in waist-hip ratio(Days 1, 28, and 56)
研究者
研究点 (2)
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