NCT03775733Unknown不适用
A 12 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate The Efficacy and Safety of Hydrolysed Red Ginseng Extract on Improvement of Hyperglycemia
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Changes of blood glucose
研究概览
简要总结
This study was conducted to investigate the effects of daily supplementation of hydrolysed red ginseng extract on improvement of Hyperglycemia.
详细描述
This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Twenty subjects were randomly divided into Hydrolysed Red Ginseng extract 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
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 19-80 years with fasting glucose 100-140 mg/dL
排除标准
- •Weight less than 48 kg or weight decreased by more than 10% within past 3 months
- •Have clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, hepatic biliary system, kidney and Urinary system, neuropsychiatry, musculoskeletal, inflammatory and hematologic malignancies, gastrointestinal disorders, etc.
- •Hypoglycemic agent, Obesity medicine, Lipid lowering agent within past 3 months
- •Blood sugar improvement or healthy functional food within past 1 month
- •Under antipsychotic medication therapy within past 2 months
- •History of alcohol or substance abuse
- •Participation in any other clinical trials within past 2 months
- •Laboratory test by show the following results
- •aspartate aminotransferase, alanine aminotransferase > Reference range 3 times upper limit
- •Serum Creatinine > 2.0 mg/dl
- •Pregnancy or breast feeding
- •If a woman of childbearing doesn't accept the implementation of appropriate contraception
- •Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc.
结局指标
主要结局
Changes of blood glucose
时间窗: 12 weeks
Changes of fasting and postprandial glucose during OGTT were assessed before and after the intervention.
次要结局
- Changes of blood insulin(12 weeks)
- Changes of area under the curve of Glucose and Insulin(12 weeks)
- Changes of Homeostatic model assessment-insulin resistance(12 weeks)
- Changes of Homeostatic model assessment-beta-cell(12 weeks)
- Changes of HbA1c(12 weeks)
- Changes of C-peptide(12 weeks)
- Changes of lipid profile(12 weeks)
研究者
Soo-Wan Chae
Principal Investigator, Clinical Trial Center for Functional Foods
Chonbuk National University Hospital
研究点 (2)
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