NCT01921881已完成1 期
Does the Natural Medicinal Plant St John's Wort Affect the Glucose Tolerance in Healthy Individuals
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Glucose area under curve (AUC) 0-2 hours
研究概览
简要总结
The goal of the study is to examine if healthy individuals that ingest St John's wort will have a significantly difference in glucose tolerance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •18-40 years
- •Fasting plasma-glucose < 7.0 mmol/L
- •Glycosylated haemoglobin A1c within reference or clinically insignificant deviation hereof
- •Body mass index < 30 kg/m^2
排除标准
- •Hypersensitivity to St John's wort
- •Chronical or daily alcohol abuse
- •Known liver disease
- •Ingestion of drugs requiring prescription, except locally acting drugs
研究组 & 干预措施
St John's wort
Experimental
Subjects will undergo 3 oral glucose tolerance tests:
- Without taking any St John's wort
- After 3 weeks pretreatment with St John's wort
- Minimum 6 weeks after last St John's wort ingestion
干预措施: St John's wort (Other)
结局指标
主要结局
Glucose area under curve (AUC) 0-2 hours
时间窗: Glucose concentration 0, 15, 30, 45, 60, 90 and 120 after glucose ingestion
At time=0, the subjects will ingest 75g glucose. Plasma glucose will be measured at 0, 15, 30, 45, 60, 90 and 120 minutes after glucose ingestion.
次要结局
- St John's wort pharmacokinetics(At time=0)
- Other metabolic markers(At time points, 0, 15, 30, 45, 60, 90, 120 minutes after glucose ingestion)
研究者
Tore B. Stage
MSc Pharm
University of Southern Denmark
研究点 (1)
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