NCT04850326已完成不适用
A Randomized, Cross-Over Clinical Study to Evaluate the Acute Efficacy of AP Green Tea Extract After a Meal Composed of High-Fat/High-Carbohydrate
适应症
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
- Change of Insulin level
研究概览
简要总结
The objective of this clinical trial is to evaluate the short term effects of single dose AP green tea extracts in subjects with BMI (< 30 kg/m2) and fasting glucose level of > 100 mg/dL after high-fat/high-carbohydrate meal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects aged 19 years or over
- •BMI < 30 kg/m2
- •Fasting glucose level > 100 mg/dL (who is not under medication)
- •Subjects who voluntarily decide to participate in this clinical study and sign the informed consent form on their own or through their representatives
排除标准
- •At the screening visit, subjects who were diagnosed with obesity, diabetes, dyslipidemia and undergoing medication
- •Subjects who were diagnosed with ventricular associated disease, unstable and uncontrolled chronic medical disease, hyper/hypothyroidism, or active malignant tumor and undergoing medication within 4 weeks prior to the first administration of the investigational product
- •Subjects who have renal failure, acute or chronic hepatitis or known liver cirrhosis
- •In addition to the above, subjects who are determined to be ineligible to participate in the clinical study according to the investigator's medical opinion
结局指标
主要结局
Change of Insulin level
时间窗: 0 - 300 minute
Change of Insulin level before and after high-carbohydrate/high-fat meal
Change of Triglyceride level
时间窗: 0 - 300 minute
Change of Triglyceride level before and after high-carbohydrate/high-fat meal
Change of Blood glucose level
时间窗: 0 - 300 minute
Change of Blood glucose level before and after high-carbohydrate/high-fat meal
次要结局
未报告次要终点
研究者
研究点 (2)
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