Determination of the Postprandial Responses to Two Cereal Foods Differing by Their SDS Content Consumed Alone.
2017年9月13日 更新者:Mondelēz International, Inc.
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.
研究概览
地位
完全的
详细说明
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.
研究类型
介入性
注册 (实际的)
20
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
New South Wales
-
Sydney、New South Wales、澳大利亚、2006
- University of Sydney
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 45年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Sandwich biscuits high in SDS
50 g of sandwich product with high level of SDS together with a glass of 250 mL of Evian water.
|
Consumption of the high SDS product (50g) alone with a glass of water
|
|
有源比较器:Co-extruded cereals low in SDS
48.3 g of co-extruded cereals low in SDS together with a glass of 250 mL of Evian water.
|
Consumption of the low SDS product (48.3
g) alone with a glass of water
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Postprandial changes in plasma glucose levels over 2 hours (iAUC [0-120 min]) after consumption of the test products
大体时间:2 hours after food consumption
|
2 hours after food consumption
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
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.
大体时间:4 hours after food consumption
|
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.
大体时间:4 hours after food consumption
|
4 hours after food consumption
|
其他结果措施
结果测量 |
大体时间 |
|---|---|
|
The plasma glucose peak value and the time for this latter will also be calculated.
大体时间:4 hours after food consumption
|
4 hours after food consumption
|
|
The plasma insulin peak value and the time for this latter will also be calculated.
大体时间:4 hours after food consumption
|
4 hours after food consumption
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Jennie Brand Miller、University of Sydney
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年9月1日
初级完成 (实际的)
2015年12月1日
研究完成 (实际的)
2015年12月1日
研究注册日期
首次提交
2015年8月31日
首先提交符合 QC 标准的
2015年8月31日
首次发布 (估计)
2015年9月2日
研究记录更新
最后更新发布 (实际的)
2017年9月14日
上次提交的符合 QC 标准的更新
2017年9月13日
最后验证
2017年9月1日
更多信息
与本研究相关的术语
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