A 8-week, Randomized, Double-blind, Placebo-controlled 2x2 Cross-over Design Human Trial to Evaluate the Efficacy and Safety of Angelica Gigas N. Extract on Improvement of Hyperglycemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 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 Angelica gigas N. extract on improvement of Hyperglycemia .
详细描述
This study was a 8 weeks, randomized, double-blind, placebo-controlled 2×2 cross-over design human trial. Twenty subjects were randomly divided into Angelica gigas N. 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
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 20-80 years with fasting glucose 100-125 mg/dL or 2 hour postprandial glucose 140-199 mg/dl
排除标准
- •Weight less than 48 kg or weight decreased by more than 10% within past 3 months
- •Hypoglycemic agent, Obesity medicine, Lipid lowering agent within past 6 months or Blood sugar, Obesity and Lipid improvement functional foods within past 2 weeks
- •Treated with corticosteroid within past 4 weeks
- •Severe cardiovascular disease(Mvocardial infarction, Stroke, etc)
- •Renal disease(Heredity hyperlipidemia, Acute/Chronic renal failure, Nephrotic syndrome, etc)
- •Rheumatoid arthritis, Autoimmune disease
- •Cancer, Respiratory organ disease(Asthma, Chronic obstructive pulmonary 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
- •Under antipsychotic drugs 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 upper limit treble
- •Serum Creatinine > 2.0 mg/dl
- •Pregnancy or breast feeding
- •Not Contraception(except: Surgery for female infertility)
研究组 & 干预措施
Angelica gigas N. extract
capsules(2cap/d, 1,000mg/d) for 8 weeks.
干预措施: Angelica gigas N. extract (Dietary Supplement)
Placebo
Placebo for 8 weeks
干预措施: Placebo (Dietary Supplement)
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 and after the intervention.
次要结局
- Changes of HbA1c(8 weeks)
- Changes of Homeostatic model assessment-insulin resistance(8 weeks)
- Changes of Homeostatic model assessment-beta-cell(8 weeks)
- Changes of Adiponectin, Leptin(8 weeks)
- Changes of lipid profile(8 weeks)
- Changes of blood insulin during OGTT(8 weeks)
研究者
Soo-Wan Chae
Principal Investigator, Clinical Trial Center for Functional Foods
Chonbuk National University Hospital