NCT01385865已完成不适用
Effect of Mulberry Leaf Extract on Blood Glucose in Subjects With Impaired Fasting Glucose
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Blood glucose change with meal tolerance test
研究概览
简要总结
The purpose of this study is to evaluate the effect of mulberry leaf extract on blood glucose in subjects with impaired fasting glucose.
详细描述
The purpose of this study is to evaluate the effect of mulberry leaf extract on blood glucose in subjects with impaired fasting glucose. After 2 weeks run-in period for wash-out, subjects will randomly assigned to two groups, i.e. control group (placebo) or mulberry leaf extract group. They will intake placebo or mulberry leaf extract for 4 weeks. Biomarkers will be analyzed in blood samples in 0 and 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: over 20 years
- •Fasting glucose: 100mg/dl ≤ ~ ≤ 125mg/dl
- •HbA1c: < 6.5%
排除标准
- •Subject who has taken medicines, Chinese medicines and Health/Functional Foods which can affect glucose metabolism in 30 days prior to screening visit
- •Subject who has taken part in other clinical trials in 30 days prior to screening visit
- •Subject who is pregnant or breast feeding
- •Subject who lost body weight over 4 kg in 30 days prior to screening visit
- •Alcoholic
- •Heavy smoker (≥ 20 cigarettes/day)
- •Subject who has heart failure, coronary artery disease, uncontrolled hypertension (≥ 140/90mmHg), diabetes (fasting blood glucose ≥ 126mg/dL), renal dysfunction, liver failure, hyperthyroidism, hypothyroidism, cancer or mental disease
- •Subject who has an allergy to the ingredients of study product
研究组 & 干预措施
Mulberry leaf extract
Experimental
干预措施: Mulberry leaf extract (Dietary Supplement)
Placebo
Placebo Comparator
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Blood glucose change with meal tolerance test
时间窗: 0wk
次要结局
- Malondialdehyde(0, 4wk)
- Blood glucose change with meal tolerance test(4wk)
- Insulin and C-peptide changes with meal tolerance test(0, 4 wk)
- Fasting blood glucose(0, 4 wk)
- Insulin(0, 4wk)
- C-peptide(0, 4wk)
- Glycated albumin(0, 4wk)
- High sensitivity C-reactive protein(0, 4wk)
- Oxidized low-density lipoprotein(0, 4wk)
- Lipid profile (triglyceride, total cholesterol, low-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol, high-density lipoprotein cholesterol)(0, 4wk)
研究者
Oran Kwon
Professor
Ewha Womans University
研究点 (1)
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