NCT02650674已完成不适用
Determination of the Glycaemic Index and Insulinaemic Index Values of Five Cereal Products
Mondelēz International, Inc.2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2015年10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
- 24
- 试验地点
- 2
- 主要终点
- Glycaemic index values of five cereal products
研究概览
简要总结
This study aimed at determining the Glycaemic Index and Insulinaemic Index Values of Five Cereal Products in two different ethnic groups.
详细描述
This study aimed at determining the Glycaemic Index and Insulinaemic Index Values of Five Cereal Products in two different ethnic groups. It is a laboratory-based research study, conducted in two different ethnic groups, with an open cross-over design, including 24 healthy non-smoking voluntary subjects, aged from 18 to 45 years. 12 subjects will be Caucasian and 12 subjects will be Asian. 8 test sessions per subject are included in the study. Foods are consumed in a random order according to a randomisation list. The impact of the ethnic group and the products will be determined.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 18-45 years.
- •Non-smoker.
- •BMI values: between 19-25 kg/m2 (bounds included) for Caucasian subjects and between 19-23 kg/m2 (bounds included) for Asian subjects (WHO expert consultation).
- •Ethnicity: Caucasian subjects will have both parents from Caucasian ancestry. Asian subjects will have both parents from Asian country and will be born in an Asian country. Asian countries are: Brunei Darussalam, Cambodia, China, Dem. People's Republic of Korea, Hong Kong SAR (China), Indonesia, Japan, Lao People's Democratic Republic, Macao SAR (China), Malaysia, Mongolia, Myanmar, Philippines, Republic of Korea, Singapore, Taiwan, Thailand, Viet Nam.
- •Sex ratio: Around half of the subjects should be male and half of the subjects should be female within each study group. A plus or minus 1 subject tolerance will be accepted.
- •Healthy subjects with:
- •Normal glucose tolerance Normal laboratory values for various measures of metabolic health (full blood count, gamma-GT, AST, ALT, glucose, TAGs, total cholesterol, HDL-cholesterol, LDL-cholesterol); Normal systolic blood pressure (100-150 mmHg); Normal diastolic blood pressure (60-90 mmHg); Normal 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 diet.
- •Family history of Diabetes Mellitus or obesity
- •Suffering from any clinical, physical or mental illness.
- •Suffering from any food allergies or hypersensitivities (wheat, milk, egg, nuts, etc).
- •Taking any regular prescription medication at the time of inclusion (except regular oral contraception medication)
- •Female who is pregnant (positive test results), lactating, planning pregnancy or not using acceptable contraceptive.
- •Females who consistently suffer from premenstrual tension and marked changes in appetite during their menstrual cycle.
- •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
Glycaemic index values of five cereal products
时间窗: 2 hours after food consumption
Determination of GI in both Caucasian and Asian subjects
次要结局
- Glycaemic response assessed by the postprandial changes in glycaemia over 2 hours (iAUC0-120) after consumption of the test products(2 hours after food consumption)
- Glycaemic response assessed by the peak value of glycemia(2 hours after food consumption)
- Glycaemic response assessed by the delta value between baseline and peak values of glycemia(2 hours after food consumption)
- Postprandial changes in insulin / glucose over 2 hours (iAUC0-120) after consumption of the test products(2 hours after food consumption)
- Glycaemic response assessed by the glycemic index (GI) values of five cereal products(2 hours after food consumption)
- Insulinaemic response assessed by the peak value of insulinemia(2 hours after food consumption)
- Insulinaemic response assessed by the delta value between baseline and peak values of insulinemia(2 hours after food consumption)
- Insulin / glucose ratio (II/GI) evaluation of five cereal products(2 hours after food consumption)
- Kinetic of insulin / glucose over the 120 minutes(2 hours after food consumption)
- Peak value of insulin / glucose ratio(2 hours after food consumption)
- Delta peak value between baseline and peak values of insulin / glucose ratio(2 hours after food consumption)
- Insulinaemic response assessed by the kinetic of insulinemia over the 120 minutes(2 hours after food consumption)
- Glycaemic response assessed by the kinetic of glycemia over the 120 minutes(2 hours after food consumption)
- Insulinaemic response assessed by the postprandial changes in insulinemia over 2 hours (iAUC0-120) after consumption of the test products(2 hours after food consumption)
- Insulinaemic response assessed by the insulinemic index (II) values of five cereal products(2 hours after food consumption)
研究者
研究点 (2)
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