A 12 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety Morus Alba L. Extract on Improvement of Blood Flow
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Changes of Reactive Hyperemia Index
研究概览
简要总结
The effect of 12 weeks intake of Morus alba L. on blood circulation improvement and related indicators is assessed compared to placebo intake.
详细描述
This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Hundred subjects were randomly divided into Morus alba L. extract or a placebo group. Blood was collected and changes in blood circulation related indicators were observed.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Those with a fasting total cholesterol of 200~239 mg/dL
- •Those with a fasting LDL-cholesterol of 130~159 mg/dL
- •Those with a fasting blood sugar of 100~125 mg/dL
- •Those with a SBP of 120~139 mmHg
- •Those with a BMI of 25~29.9 kg/m^2
- •Waist Hip Ratio (WHR) is 0.9 or more for males and 0.85 or more for females
排除标准
- •Those with platelet aggregation and significant disability
- •The platelet count is less than 100,000/μL or more than 500,000/μL
- •The Hematocrit is less than 25%
- •BMI is less than 18.5kg/m^2 or greater than 30kg/m^2
- •Those with clinically significant severe cardiovascular, endocrine, immune, respiratory, liver, biliary, renal and urinary tract, neuropsychiatry, musculoskeletal, inflammatory and hematologic and gastrointestinal disorders
- •Those with a history of clinically significant hypersensitivity to mulberry
- •Those who have been taking platelet function, blood circulation improvement and hyperlipidemia related medicines, health functional food or herbal medicine continuously for more than 7 days within one month before screening
- •Those who have received antipsychotic medication within 2 months before screening
- •Those who participated in other clinical trials within 3 months before screening
- •Women receiving hormone replacement therapy
- •Laboratory test by show the following results
- •AST, ALT > Reference range 3 times upper limit
- •Serum Creatinine > 2.0 mg/dL
- •Pregnancy or breast feeding
- •Those who doesn't accept the implementation of appropriate contraception of a childbearing woman
- •Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc.
结局指标
主要结局
Changes of Reactive Hyperemia Index
时间窗: 12 weeks
Reactive Hyperemia Index was measured in study visit 1(0 week) and visit 3(12 weeks).
Changes of Platelet function assay
时间窗: 12 weeks
The whole blood with anticoagulant (sodium citrate) is passed through the capillary and the membrane to assess the degree of platelet adhesion to this membrane and the degree of occlusion of the capillary.
次要结局
- Changes of blood flow indices: PAI-1, t-PA(12 weeks)
- Changes of Lipid metabolism indices: Total cholesterol, Triglyceride, LDL-C, HDL-C(12 weeks)
- Changes of Arteriosclerosis indices: Total cholesterol/HDL-C, LDL-C/HDL-C, Triglyceride/HDL-C, (Total cholesterol-HDL-C)/HDL-C(12 weeks)
- Changes of Pulse wave(12 weeks)
- Changes of Oxidation stress index: Oxidized LDL(12 weeks)
- Changes of Lipid peroxidation index: MDA (Malondialdehyde)(12 weeks)
研究者
Soo-Wan Chae
Principal Investigator, Clinical Trial Center for Functional Foods
Chonbuk National University Hospital