Development of Methodology for Use of Continuous Blood Glucose Measurements When Evaluating Meal Effects on Glucose Regulation - a Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Postprandial glucose response
研究概览
简要总结
The specific goal of this pilot study is to evaluate if it is possible to detect a statistical difference in postprandial glycemia after meals served with and without a drink previously shown to reduce postprandial glycemia by about 25%. A third drink, with a new recipe, is also included for comparisons. Six participants will carry continuous blood glucose monitors for 10 days and follow a specific meal schedule. The data from this study will form the basis for forming hypothesis of future studies as well as make appropriate calculations of statistical power.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 25-29.9 kg/m^2
- •HOMA-IR < 2.5
- •Fasting glucose < 6.1 mmol/L
- •Stable weight since 3 months
- •Access to iPhone with Bluetooth 4.0 and iOS 13 or later
排除标准
- •Pharmacological treatment known to interfer with metabolism
- •Antibiotics treatment the latest 3 months
- •Vegetarian/Vegan diet
- •Use of tobacco
- •Pregnancy or breast-feeding
结局指标
主要结局
Postprandial glucose response
时间窗: From start of meal (0 min) to 120 min postprandially
Incremental area under the blood glucose curve after each meal
次要结局
- Glycemic variability(24 hour cycles)
