An 8 Weeks, Randomized, Double-blind, Placebo-controlled Clinical Trial for Anti-diabetic Effects of Hydrolyzed Ginseng Extract
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Changes of blood glucose during OGTT(oral glucose tolerance test)
研究概览
简要总结
This study was conducted to investigate the effects of daily supplementation of hydrolyzed ginseng extract(HGE) on glycemic status in subjects with impaired fasting glucose(IFG).
详细描述
This study was a 8 weeks, randomized, double-blind, placebo-controlled trial. Twenty subjects were randomly divided into HGE or a placebo group. Fasting and postprandial glucose profiles during oral glucose tolerance test (OGTT) were assessed before and after the intervention.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 20-70 years with fasting glucose 100~126 mg/dL
排除标准
- •Abnormal lipid profile values
- •Acute/chronic inflammation
- •Treated with corticosteroid within past 4 weeks
- •Cardiovascular disease
- •Allergic or hypersensitive to any of the ingredients in the test products
- •History of disease that could interfere with the test products or impede their absorption
- •Participation in any other clinical trials within past 2 months
- •Renal disease
- •Abnormal hepatic function
- •Under hypolipidemic drugs therapy within past 3 months
- •Under antipsychotic drugs therapy within past 2 months
- •Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
- •History of alcohol or substance abuse
- •Pregnancy or breast feeding
结局指标
主要结局
Changes of blood glucose during OGTT(oral glucose tolerance test)
时间窗: 8 weeks
Changes of fasting and postprandial glucose during OGTT were assessed before(baseline) and after the intervention.
次要结局
- Changes of blood insulin during OGTT.(8 weeks)
- Changes of glycated albumin, fructosamine, and lipid profile(8 weeks)
研究者
Soo-Wan Chae
Principal Investigator, Clinical Trial Center for Functional Foods
Chonbuk National University Hospital