Grape Polyphenols and Second-meal Effect (GRAPESECOND)
2020年2月24日 更新者：Jara Pérez-Jiménez、National Research Council, Spain
Potential Modulatory Effect of Whole Grape on Second-meal Tolerance in Obese Subjects: Role of Polyphenols
The aim of this is study is to evaluate the effects of a single intake of grapes (a polyphenol-rich food) in postprandial metabolism in subjects with obesity, including a first intake (high-fat breakfast) after overnight fasting a second one (medium-fat lunch).
Studies on the effects of polyphenols on postprandial (glucidic and lipidic) metabolism have commonly been performed in animal models and have used grape extracts, ignoring the whole pool of polyphenols present in grapes (extractable and non-extractable polyphenols).
Besides, the contribution of polyphenols to the so-called second-meal effect has not been explored.
It should be highlighted that this study aims to explore the potential beneficial role of fresh grapes, consumed as fruit; in order to ensure the stability of the product, they will be provided as freeze-dried milled material, but the amount received by the subjects could be incorporated into a common diet, being equivalent to 300 g of fresh grapes.
研究概览
详细说明
Twenty-five subjects with obesity will be were recruited. Detailed inclusion and exclusion criteria are provided below.
The subjects will receive, after overnight fasting, either a monodose of freeze-dried grapes (equivalent to 300 g of fresh grapes) or isocaloric placebo solved in water, together with a high-fat breakfast. Blood samples will be collected before the intake, up to 5 h after breakfast, then a medium-fat lunch will be provided and blood samples will be collected for three additional hours. Both interventions will be separated by two weeks. The following determinations will be performed in blood samples collected at different periods: glucose, insulin, triglycerides, uric acid, viscosity, antioxidant capacity. Additionally, a satiety test will be provided. It is expected that grape supplementation, as compared with an isocaloric placebo, causes significant modifications in all the parameters indicated. Nevertheless, the primary outcome of this study is the area under the curve for glucose after the second meal (300-420 min from basal time).
研究类型
介入性
注册 (实际的)
25
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
-
-
-
Madrid、西班牙、28040
- Institute of Food Science, Technology and Nutrition, National Research Council (ICTAN-CSIC)
-
-
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 70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:
- Obesity (BMI = 30-40 kg/m2).
Exclusion Criteria:
- Subjects with a pharmaceutical treatment set to modify blood pressure, lipid profile or glucose.
- Subjects with diagnoses of type 2 diabetes, cardiovascular diseases or thyroid diseases.
- Values above the following ones: glucose, > 115 mg/dL; triglycerides, > 350 mg/dL; total cholesterol, > 280 mg/dL; systolic blood pressure, > 150 mmHg; diastolic blood pressure, > 100 mmHg
- Previous bariatric surgery.
- Volunteers participating in other studies (currently or during last year) or weight loss plans.
- Pregnant or breastfeeding women.
- Adherence to vegetarian diets or usual consumption of dietary supplements.
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：基础科学
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：1
All subjects will receive a high-fat breakfast and a medium-fat lunch twice.
They will consume together with the breakfast the placebo (PLA) the first time and grape (GRAP) the second time.
|
The subjects will receive, after overnight fasting, either a monodose of freeze-dried grapes (equivalent to 300 g of fresh grapes) or isocaloric placebo solved in water, together with a high-fat breakfast.
Blood samples will be collected before the intake, up to 5 h after breakfast, then a medium-fat lunch will be provided and blood samples will be collected for three additional hours.
A total of 10 samples will be collected: 0-30-60-120-180-240-300-330-360-420 min.
Both interventions will be separated by two weeks.
Subjects will be instructed not to modify their dietary habits during the development of the study, but during the 72 h before each visit they will have to restrict the intake of polyphenol-rich foods (a detailed list will be provided).
|
|
实验性的：2
All subjects will receive a high-fat breakfast and a medium-fat lunch twice.
They will consume together with the breakfast grape (GRAP) the first time and the placebo (PLA) the second time.
|
The subjects will receive, after overnight fasting, either a monodose of freeze-dried grapes (equivalent to 300 g of fresh grapes) or isocaloric placebo solved in water, together with a high-fat breakfast.
Blood samples will be collected before the intake, up to 5 h after breakfast, then a medium-fat lunch will be provided and blood samples will be collected for three additional hours.
A total of 10 samples will be collected: 0-30-60-120-180-240-300-330-360-420 min.
Both interventions will be separated by two weeks.
Subjects will be instructed not to modify their dietary habits during the development of the study, but during the 72 h before each visit they will have to restrict the intake of polyphenol-rich foods (a detailed list will be provided).
|
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 |
|---|---|---|
|
Postprandial glucose (300-420 min)
大体时间：Up to two months
|
Changes of postprandial blood glucose as result of supplementation with grapes, measured area under the curve for the period 300-420 min
|
Up to two months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Postprandial glucose and insulin
大体时间：Up to four months
|
Changes of blood glucose (0-320 min) and insulin (0-300 and 300-420 min) as result of supplementation with grapes
|
Up to four months
|
|
Plasma triglycerides
大体时间：Up to four months
|
Changes of plasma triglycerides (0-300 and 300-420 min) as result of supplementation with grapes
|
Up to four months
|
|
Plasma uric acid
大体时间：Up to four months
|
Changes of plasma uric acid (0-300 and 300-420 min) as result of supplementation with grapes
|
Up to four months
|
|
Plasma antioxidant capacity
大体时间：Up to five months
|
Changes of plasma antioxidant capacity (0-300 and 300-420 min) as result of supplementation with grapes
|
Up to five months
|
|
Plasma viscosity
大体时间：Up to six months
|
Changes of plasma viscosity (0-300 and 300-420 min) as result of supplementation with grapes.
|
Up to six months
|
|
Satiety
大体时间：Up to three months
|
Changes of satiety (0-300 and 300-420 min) as result of supplementation with grapes.
|
Up to three months
|
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：Jara Pérez-Jiménez, PhD、Institute of Food Science, Technology and Nutrition (ICTAN-CSIC)
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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12月10日
初级完成 (实际的)
2019年11月1日
研究完成 (实际的)
2020年2月15日
研究注册日期
首次提交
2018年11月13日
首先提交符合 QC 标准的
2018年11月13日
首次发布 (实际的)
2018年11月14日
研究记录更新
最后更新发布 (实际的)
2020年2月25日
上次提交的符合 QC 标准的更新
2020年2月24日
最后验证
2020年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.