NCT01870570已完成不适用
Determination of Glycaemic Index and Insulinaemic Index Values of 6 Cereal Products in 3 Separate Research Centers
Mondelēz International, Inc.5 个研究点 分布在 3 个国家目标入组 48 人开始时间: 2013年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 5
- 主要终点
- Determine and Perform Inter-Laboratory Comparison of Glycaemic Index Values of 6 Food Products
研究概览
简要总结
The purpose of this study is to determine and compare the glycaemic index values and response parameters of 6 food products between 3 laboratories.
详细描述
This study will be performed at 3 centers and 15 subjects will be recruited at each center.
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
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18-35 years inclusive.
- •Non-smoker.
- •BMI 19.0-25.0 kg/m2 inclusive.
- •Healthy subjects with:
- •Fasting plasma glucose < 5,6 mM (ADA criteria,2011)
- •Insulin resistance index based on homeostasis model assessment (HOMA-IR) <1.70
- •Fasting lipids: triglyceride <1.70mmol/L, LDL-cholesterol<5.00 mmol/L and HDL-cholesterol >1.03mmol/L for males or >1.29mmol/L for females (IDF criteria for metabolic syndrome, 2006)
- •Gamma-GT, AST and ALT <1.5 times the upper limit of normal (ULN)
- •Complete blood count: Normal full blood count according to the investigator
- •Systolic blood pressure <130 mmHg
- •Diastolic blood pressure <85 mmHg
- •Resting heart rate 50-90 beats per minutes (after 3 minutes rest).
- •Stable dietary habits; normal eating patterns; no history of eating disorders or strict dieting.
- •Moderate level of physical activity (from basic daily activity to a high level of physical activity (regular physical activity at least 3 times per week))
- •Able to fast for at least 10 hours the night before each test session.
- •Able to refrain from eating legumes and drinking alcohol the day before each test session.
- •Subject covered by social security or covered by a similar system
- •Subject not taking any treatment for anorexia, weight loss, or any form of treatment likely to interfere with metabolism or dietary habits
- •Subject having given written consent to take part in the study
排除标准
- •Following a restrictive or specific diet.
- •Suffering from any inflammatory or metabolic diseases
- •Suffering from mental illness.
- •Suffering from any food allergies or hypersensitivities (wheat, milk, egg, nuts, etc).
- •Taking any regular prescription medication at the time of inclusion that should interfere with carbohydrate metabolism (except regular oral contraception medication, thyroid replacement therapy)
- •Female who is pregnant (positive test results), lactating, planning pregnancy or not using acceptable contraceptive.
- •Subject having taken part in another clinical trial within the last week.
- •Subject currently taking part in another clinical trial or being in the exclusion period of another clinical trial.
- •Subject undergoing general anaesthesia in the month prior to inclusion.
- •Subject in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject.
结局指标
主要结局
Determine and Perform Inter-Laboratory Comparison of Glycaemic Index Values of 6 Food Products
时间窗: 0-120 minutes
次要结局
- Determine and Perform Inter-Laboratory Comparison of Insulinemic Index for Each of the 6 Food Products(0-120 minutes)
- Determine and Perform Inter-Laboratory Comparison of Incremental Area Under the Curve (iAUC) of Glycaemia for Each of the 6 Food Products(0-120 minutes)
- Determine and Perform Inter-Laboratory Comparison of the Glucose Cmax for Each of the 6 Food Products(0-120 minutes)
- Determine and Perform Inter-Laboratory Comparison of the Blood Glucose Delta Peak for Each of the 6 Food Products(0-120 minutes)
- Determine and Perform Inter-Laboratory Comparison of the Incremental Area Under the Curve (iAUC) of Insulinemia for Each of the 6 Food Products(01-20 minutes)
- Determine the Intra-Laboratory Variability of the iAUC of Insulinemia(0-120 minutes)
- Determination and Perform Inter-Laboratory Comparison of Insulin Cmax for Each of the 6 Food Products(0-120 minutes)
- Determine and Perform Inter-Laboratory Comparison of the Blood Insulin Delta Peak for Each of the 6 Food Products(0-120 minutes)
- Determine the Intra-Laboratory Variability for the iAUC of Glycaemia(0-120 minutes)
研究者
研究点 (5)
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