NCT02538653已完成不适用
Determination of the Postprandial Responses to Two Cereal Foods Differing by Their SDS Content 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9月1日最近更新:
适应症
干预措施
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
- Postprandial changes in plasma glucose levels over 2 hours (iAUC [0-120 min]) after consumption of the test products
研究概览
简要总结
This study aimed at determining the 4-hours postprandial blood glucose and insulin responses to the ingestion of cereal product differing by their SDS content.
详细描述
This study aimed at determining the 4-hours postprandial blood glucose and insulin responses to the ingestion of cereal product differing by their SDS content. It is a laboratory-based research study with an open cross-over design, including 20 healthy non-smoking voluntary subjects, aged from 18 to 45 years. 2 test sessions per subject are included in the study. Foods are consumed in a random order according to a randomisation list.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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 < 6.0 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.
研究组 & 干预措施
Sandwich biscuits high in SDS
Experimental
50 g of sandwich product with high level of SDS together with a glass of 250 mL of Evian water.
干预措施: Sandwich biscuit high in SDS (Other)
Co-extruded cereals low in SDS
Active Comparator
48.3 g of co-extruded cereals low in SDS together with a glass of 250 mL of Evian water.
干预措施: Co-extruded cereal low in SDS (Other)
结局指标
主要结局
Postprandial changes in plasma glucose levels over 2 hours (iAUC [0-120 min]) after consumption of the test products
时间窗: 2 hours after food consumption
次要结局
- Postprandial changes in glycaemia over 3 hours (iAUC [0-180]), 4h (iAUC[0-240]), during the second part of the morning (iAUC [120-240] and iAUC[180-240]) following the intake of the test products will be analysed.(4 hours after food consumption)
- Postprandial changes in insulinemia over 2 hours (iAUC [0-120]), over 3 hours (iAUC [0-180]), 4 hours (iAUC[0-240]), during the second part of the morning (iAUC [120-240] and iAUC [180-240]) following the intake of the test products will be analysed.(4 hours after food consumption)
研究者
研究点 (2)
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