Effects of Added D-fagomine on Glycaemic Responses to Sucrose
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
- Postprandial Glycaemic Response Index
研究概览
简要总结
The purpose of this study is to determine whether D-fagomine affects glycaemic responses to sucrose (commercial white sugar)and quantify the response
详细描述
This is a two treatment randomized double-blind crossover study, with each test product replicated twice.
Randomization: Subjects will be randomized to a Williams Latin square design balanced for treatment order.
Washout: 2 days or more (may return on day 3)
Run-in: High carbohydrate diet guidance (>150 g/d) 1 day before treatment, recommend same sized dinner the previous night (no food record collection required)
Drop-outs: Subjects who have dropped out before visit 2 will be replaced by another subject randomized in their place (the new subject will complete all treatments)
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female (not less than 40% Male)
- •Aged 18 - 55 years
- •Have a body mass index between 18.5 to 29.99 kg/m2
- •Healthy, non-diabetic, no gastric bypass surgery
- •Have a fasting plasma glucose (finger-stick) <100 mg/dl (<5.5 mmol/L)
- •Willing and able to provide written informed consent
排除标准
- •Allergic to dairy or soy
结局指标
主要结局
Postprandial Glycaemic Response Index
时间窗: 120 minutes
On each intervention, the volunteer measured a baseline fasting blood sugar measurement for that day and repeated this approximately 5 minutes later so that two fasting measurements were obtained under the supervision of staff. All of the subsequent measurements were assessed against the average of the two baseline readings. Each subject was then presented with a test product and they were instructed to consume the whole amount within a fifteen-minute period. Each volunteer then took a blood sugar readings at 15, 30, 45, 60, 90 and 120 minutes following the initiation of consumption of the test product. Measurements were taken using the Ascensia Contour, Blood Glucose Monitoring Systems (Bayer), which analysed the blood sample and provided a blood glucose reading in mmol/l. The AUC is calculated using the trapezoid rule and the final outcome is the incremental area under the curve for the arm expressed as a percent of the average response for the control by the same subject.
次要结局
- Maximum Blood Glucose Concentration (C Max) Over the Baseline(Usually in the range of 30-45 minutes)