Coffee and Glucose Metabolism: Clinical, Crossover and Randomized Glucose Disposal Assay Using Stable Isotopes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- ODILE minimal model analysis
研究概览
简要总结
Epidemiological studies have shown an inverse association between coffee consumption and risk of type 2 diabetes mellitus (T2DM). However the experimental studies that analysed the mechanisms are limited.
This project aims to assess the effects of coffee consumption on glucose metabolism, using stable isotope tracer (13C-glucose) to explain the possible metabolic mechanisms involved on the reduced risk for T2DM.
详细描述
This is a crossover randomized clinical trial that has been studying 14 male healthy young adults, who were enrolled five treatments: coffee with sugar, coffee without sugar, decaffeinated coffee without sugar and two controls (water with and without sugar).
The stable isotope minimal model protocol with oral glucose administration (Oral Dose Intravenous Label Experiment - ODILE) was performed. The use of ODILE methodology permits separation of the glucose absorbed and removed from the circulation increasing the accuracy and the effectiveness of glucose uptake and insulin sensitivity (Bluck et al., 2006).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male healthy young adults (18 - 50 years old);
- •Body mass index (BMI) between 18.5 - 28.0 kg/m²;
- •No weight changes (≥ 5 kg) in the last 3 months;
- •Not take any pills/drugs that alter metabolism, appetite and sleep;
- •Not have sleep disorders;
- •Not have donated blood in the last 3 months;
- •Regular breakfast consumption (≥100 kcal ingested up to 2 hours after waking ≥4x/week);
- •Being a habitual coffee consumer (≥100mL ≥5x/week).
排除标准
- •Diagnosis of anemia, metabolic and heart diseases;
- •Previous sudden fainting and convulsions;
- •Any drugs and tobacco consumption;
- •Consumption of more than 500mg of caffeine / day (5 cups of coffee, tea and cola soft drinks).
结局指标
主要结局
ODILE minimal model analysis
时间窗: -10, 0, 30, 60/0, 15, 30, 45, 47, 49, 51, 53, 55, 57, 59, 61, 65, 70, 75, 80, 85, 90, 100, 115, 135, 165, 195, 225 minutes.
The stable isotope minimal model protocol with oral glucose administration (Oral Dose Intravenous Label Experiment - ODILE)
次要结局
- Glucose metabolism(-10, 0, 30, 60/0, 15, 30, 45, 47, 49, 51, 53, 55, 57, 59, 61, 65, 70, 75, 80, 85, 90, 100, 115, 135, 165, 195, 225 minutes.)
研究者
Caio Eduardo Gonçalves Reis
Principal Investigator
University of Brasilia