The Effect of Different Flour Compositions in a Carbohydrate-based Food on Rate of Exogenous Glucose Appearance in Blood.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Rate of appearance of exogenous glucose (RaE) based on the dual isotope technique.
研究概览
简要总结
Exploratory study with double-blind, randomized, placebo-controlled, full cross-over design.
The main objective is to identify one or two flour compositions in a carbohydrate-based food that produce a significant difference (alpha =0.2) in the time to reach 50% of cumulative absorption of exogenous glucose compared to the control.
详细描述
Twelve volunteers will participate in the study; each person will be studied on three different occasions at least one week apart, consuming the three different test products in a randomized order. Test products are carbohydrate-based food made from different flour mixes differing in their expected rate of intestinal starch digestion. The products are labeled with 13C starch.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •healthy males
- •Age at start of the study ≥18 and ≤ 50 years
- •Not smoking
- •Body mass index (BMI) ≥ 20 and ≤ 28 kg/m2
- •Fasting blood glucose value of volunteer is ≥ 3.4 and ≤ 6.1 mmol/litre (i.e. 62-110 mg/dl) at screening
排除标准
- 未提供
结局指标
主要结局
Rate of appearance of exogenous glucose (RaE) based on the dual isotope technique.
时间窗: Measured during 360 min for 3 periods
次要结局
- Total blood glucose and insulin(Measured during 360 min for 3 periods)