NCT02538640已完成不适用
Determination of the Postprandial Responses to Two Cereal Foods Differing by Their SDS Content and GI Consumed Alone.
Mondelēz International, Inc.2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年8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
- 20
- 试验地点
- 2
- 主要终点
- Glycemic Response over 2 hours
研究概览
简要总结
This is a laboratory-based research study conducted in two parts. Open cross-over design. 2 test sessions per subject included in the study. It aims at determining the postprandial blood glucose and insulin responses to the ingestion of cereal product differing by their SDS content and GI in 20 healthy non-smoking voluntary subjects, aged from 18 to 45 years.
详细描述
This is a laboratory-based research study conducted in two parts. Open cross-over design. 2 test sessions per subject included in the study. It aims at determining the postprandial blood glucose and insulin responses to the ingestion of cereal product differing by their SDS content and GI in 20 healthy non-smoking voluntary subjects, aged from 18 to 45 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 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 19-30 kg/m2 (bounds included). Around half of the subjects will be normal weight and the other half overweight.
- •Ethnicity. Subjects should have the closest characteristics compared to the American population. Not less than 75% but not more than 90% of the subjects should be Caucasian. Not more than 10% of the subjects will be of Asian or Asian Indian descent. The remaining subjects will be from other ethnic groups except from Australian Aborigines.
- •Healthy subjects with:
- •Normal glucose tolerance (fasting blood glucose < 6.0 mmol/L during the first test session and results of oral glucose tolerance test conducted within the last 30 days within recommendations (fasting blood glucose < 6.1 mmol/L, 120 minute glucose < 8.9 mmol/L))
- •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 tointerfere 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)
- •Subject from the Australian Aboriginal ethnicity.
- •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
Glycemic Response over 2 hours
时间窗: 2 hours
iAUC of glycemia over 2 first hours of postprandial period
次要结局
- Blood glucose kinetic(4 hours)
- Blood insulin peak(4 hours)
- Blood glucose peak(4 hours)
- Insulinemic response(4 hours)
- Blood insulin kinetic(4 hours)
- Glycemic response(4 hours)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Determination of the Postprandial Responses to Two Cereal Foods Differing by Their SDS Content Consumed Alone.Metabolic Disorder Carbohydrate, Absorption, IntestineNCT02538653Mondelēz International, Inc.20
已完成
不适用
Glycemic Response in Adults With Type 2 DiabetesGlycemic ControlNCT05166200Abbott Nutrition26
已完成
不适用
Postprandial Glycemic Response in Adults With Type 2 DiabetesGlycemic ControlNCT05154045Abbott Nutrition26
已完成
不适用
A Clinical Study to Investigate and Compare the Impact of High Protein Pasta, Lower Protein Pasta and White Rice on Blood Sugar Control in People With Type 1 Diabetes Mellitus (T1DM)Diabetes Mellitus, Type 1NCT03362151Sansum Diabetes Research Institute14
尚未招募
不适用
To investigate the acute effect of chilli intake on plasma glucose, insulin and blood vessel function in type-2 diabetics.Hyperglycemia and hyperinsulinemia associated with type-2 diabetes.Metabolic and Endocrine - DiabetesACTRN12609000897268niversity of Tasmania35