Hypoglycemic Effects of Fermented Red Ginseng in Subject With Impaired Fasting Glucose or Type 2 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Glucose profiles during meal tolerance test
研究概览
简要总结
This study was conducted to investigate the effects of daily supplementation of fermented red ginseng (FRG) on glycemic status in subjects with impaired fasting glucose (IFG) or type 2 diabetes.
详细描述
This study was a 4 weeks, randomized, double-blind, placebo-controlled trial. Forty-two subjects with IFG or type 2 diabetes were randomly allocated to 2 groups to consume placebo or FRG three times per day for 4 weeks. Fasting and postprandial glucose profiles during meal tolerance test 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20-75 years with fasting glucose 100~140 mg/dL at least two of the following
排除标准
- •Lipid metabolic disorder
- •Acute or chronic inflammatory disease
- •Taking medication of corticosteroid within 4 weeks of the study
- •Cardiovascular disease (arrhythmia, heart failure, myocardial infarction or patient with pacemaker)
- •Allergic or hypersensitive to any of the ingredients in the test products
- •Participation in other clinical trials within 2 months
- •Abnormal hepatic liver function or renal disease (acute/chronic renal failure or nephrotic syndrome)
- •Taking medication of lipid phosphates within 3 months of the study etc,
研究组 & 干预措施
Fermented red ginseng
干预措施: Fermented Red Ginseng (Dietary Supplement)
Placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Glucose profiles during meal tolerance test
时间窗: 4 weeks
Fasting and postprandial glucose profiles during meal tolerance test were assessed before(baseline) and after the intervention
次要结局
- Change in lipid profiles(4 weeks)
研究者
Soo-Wan Chae
Principal Investigator, Clinical Trial Center for Functional Foods
Chonbuk National University Hospital