Effect of Changes in Glucose Intake and Sweet Perception on Post Prandial Glycaemia
2018年8月2日 更新者：Société des Produits Nestlé (SPN)
Sugar-sweetened beverages are the main source of added sugars in most Westernized countries, and for this reason constitute a primary target for sugar reduction by many companies, including Nestlé. Instead of using high-intensity sweeteners which are non-caloric in nature, an alternative would be to reduce sugars without altering sweetness.
In this protocol, the general goal is to investigate the relative contribution of sweet taste perception and sugar intake on post-prandial glucose response. 4 different nutritional products will be tested by 16 healthy subjects in a crossover design.
研究概览
详细说明
After enrollment, participants will be asked to come to the investigational site 6 times for:
- two sensory tests dedicated to assess the sensory capacity of the participants from the same sensory test repeated twice, for better consistency.
- 4 testing visits for a 3-h blood kinetics after each product intake. These visits will be scheduled on different days separated by a washout period of at least one week. Outcomes will be glycemia and insulinemia.
研究类型
介入性
注册 (实际的)
16
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
-
-
-
Lausanne、瑞士、1000
- Nestlé Research Center
-
-
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 65年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- BMI between 18.5 and 29.9 kg/m2
- Fasting capillary blood glucose level ≤ 7 mmol/L
- Able to understand and sign an informed consent form
Exclusion Criteria:
- Pregnancy on anamnesis
- Lactating mothers
- Individuals undergoing either dietary or exercise mediated weight loss program prescribed by a health care professional
- Medically-treated diabetes mellitus or use of anti-hyperglycemic drugs or insulin
- Family history of type 2 diabetes (parents)
- Any other metabolic disease possibly impacting the postprandial glucose and insulin response (to the opinion of the medical doctor)
- Known ageusia or other tasting trouble
- Chronic intake of medications known to affect glucose tolerance to the opinion of the investigator (steroids, protease inhibitors, antidepressants, anxiolytic, or antipsychotics)
- Presence of disease or intake of drug that affects digestion and absorption of nutrients, to the opinion of the medical doctor
- Major medical/surgical event requiring hospitalisation in the last 3 months
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：其他
- 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 |
|---|---|
|
安慰剂比较：Product 1
Normal glucose, isosweet, homogeneous: 43 g glucose beverage, with a 43 g glucose equivalent sweetness homogenously delivered
|
Comparison with products 1, 3, and 4
Comparison with products 1, 2, and 4
Comparison with products 1, 2, and 3
|
|
有源比较器：Product 2
Low glucose, isosweet, heterogeneous: 30 g glucose beverage with 43 g glucose equivalent sweetness heterogeneously delivered
|
Comparison with products 1, 2, and 4
Comparison with products 1, 2, and 3
Comparison with products 2, 3, and 4
|
|
有源比较器：Product 3
Low glucose, less sweet, homogeneous: 30 g glucose beverage with a 30 g glucose equivalent sweetness homogenously delivered
|
Comparison with products 1, 3, and 4
Comparison with products 1, 2, and 3
Comparison with products 2, 3, and 4
|
|
有源比较器：Product 4
Low glucose+sucralose, isosweet, homogeneous: 30 g glucose + 18 mg sucralose beverage with a 43 g glucose equivalent sweetness homogenously delivered
|
Comparison with products 1, 3, and 4
Comparison with products 1, 2, and 4
Comparison with products 2, 3, and 4
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incremental Area under the Curve (iAUC) of plasma glucose
大体时间：0 to 3 hours post product intake
|
Area under the curve
|
0 to 3 hours post product intake
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incremental Area under the Curve (iAUC) of plasma insulin
大体时间：0 to 3 hours post product intake
|
Area under the curve
|
0 to 3 hours post product intake
|
|
Cmax of plasma glucose
大体时间：between 0 and 3 hours post product intake
|
Maximal concentration of plasma glucose
|
between 0 and 3 hours post product intake
|
|
Cmax of plasma insulin
大体时间：between 0 and 3 hours post product intake
|
Maximal concentration of plasma insulin
|
between 0 and 3 hours post product intake
|
|
Tmax of plasma glucose
大体时间：between 0 and 3 hours post product intake
|
Time (min) for maximal concentration of plasma glucose
|
between 0 and 3 hours post product intake
|
|
Tmax of plasma insulin
大体时间：between 0 and 3 hours post product intake
|
Time (min) for maximal concentration of plasma insulin
|
between 0 and 3 hours post product intake
|
|
Sensory tasting capacity
大体时间：immediately after product intake
|
Assessment of the sweetness of two beverages versus control through a questionnaire
|
immediately after product intake
|
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：Maurice Beaumont, MD、Société des Produits Nestlé (SPN)
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 (实际的)
2018年2月19日
初级完成 (实际的)
2018年4月20日
研究完成 (实际的)
2018年4月20日
研究注册日期
首次提交
2018年7月9日
首先提交符合 QC 标准的
2018年8月2日
首次发布 (实际的)
2018年8月3日
研究记录更新
最后更新发布 (实际的)
2018年8月3日
上次提交的符合 QC 标准的更新
2018年8月2日
最后验证
2018年8月1日
更多信息
与本研究相关的术语
其他研究编号
- 17.19.BIO
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研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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