Glycaemic, Insulinaemic, Gastric Inhibitory Polypeptide (GIP) and Glucagon-like Peptide-1 (GLP-1) Response for Glucose, Glucose With 25 g Nutralys S85 Plus and Glucose With 50 g Nutralys S85 Plus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Change in blood glucose response from baseline for 3 hours
研究概览
简要总结
The aim of this study was to compare the glycaemic response, insulinaemic response, GIP response and GLP-1 response to glucose, 25 g Nutralys S85 Plus and 50 g Nutralys S85 Plus using a single-blind, randomised, repeat measure, crossover design trial.
详细描述
The aims of this study were to examine:
-
Phase I - the glycaemic response (GR) and insulinaemic response (IR) to:
-
50 g available carbohydrate
-
50 g available carbohydrate + protein (dose 1)
-
50 g available carbohydrate + protein (dose 2)
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Phase II - the GLP-1 and GIP response to:
-
50 g available carbohydrate
-
50 g available carbohydrate + protein (dose 1)
-
50 g available carbohydrate + protein (dose 2)
A single-blind, randomised, repeat measure, crossover design trial was used to study the response following consumption of three meals: one reference meal (50 g available carbohydrate) and two test meals (50 g available carbohydrate with protein dose 1 and 50 g available carbohydrate with protein dose 2). The study was conducted in two phases:
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 (Participant)
盲法说明
single-blind
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 to 60 years
- •Body mass index (BMI) less than 30kg/m2
排除标准
- •Pregnant or lactating
- •Fasting blood glucose value > 6.1 mmol/l
- •Any known food allergy or intolerance
- •Medical condition(s) or medication(s) known to affect glucose regulation or appetite and/or which influence digestion and absorption of nutrients
- •Known history of diabetes mellitus or the use of antihyperglycaemic drugs or insulin to treat diabetes and related conditions
- •Major medical or surgical event requiring hospitalization within the preceding 3 months
- •Use of steroids, protease inhibitors or antipsychotics (all of which have major effects on glucose metabolism and body fat distribution).
- •Unable to comply with experimental procedures or did not follow GR testing safety guidelines.
结局指标
主要结局
Change in blood glucose response from baseline for 3 hours
时间窗: 3 hours
Change in postprandial blood glucose response from baseline was measured at 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours and 3 hours
Change in plasma insulin response from baseline for 3 hours
时间窗: 3 hours
Change in postprandial plasma insulin response from baseline was measured at 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours and 3 hours
Time of blood glucose peak (Tmax)
时间窗: 0-3 hours
Time of blood glucose peak after consumption of the test food
Peak blood glucose concentration (Cmax)
时间窗: 0-3 hours
Peak blood glucose concentration (Cmax) after consumption of the test food
Area under the plasma insulin concentration versus time curve
时间窗: 3 hours
Area under the plasma insulin concentration versus time curve was calculated by trapezoidal rule
Peak plasma insulin concentration (Cmax)
时间窗: 0-3 hours
Peak plasma insulin concentration (Cmax) after consumption of the test food
Time of plasma insulin peak (Tmax)
时间窗: 0-3 hours
Time of plasma insulin peak after consumption of the test food
Area under the blood glucose concentration versus time curve
时间窗: 3 hours
Area under the blood glucose concentration versus time curve was calculated by trapezoidal rule
次要结局
- Area under the plasma GIP concentration versus time curve(3 hours)
- Change in GLP-1 from baseline for 3 hours(3 hours)
- Change in GIP from baseline for 3 hours(3 hours)
- Peak plasma GLP-1 concentration (Cmax)(0-3 hours)
- Peak plasma GIP concentration (Cmax)(0-3 hours)
- Time of plasma GIP peak (Tmax)(0-3 hours)
- Area under the plasma GLP-1 concentration versus time curve(3 hours)
- Time of plasma GLP-1 peak (Tmax)(0-3 hours)
研究者
Dr. Sangeetha Thondre
Principal Investigator
Oxford Brookes University