Effect of a Plant-based Ingredient on Generalized Hormonal Responses
2014年4月8日 更新者:Unilever R&D
The study is designed to determine the extent to which foods containing a plant-based ingredient affect blood glucose and hormonal response in healthy subjects.
研究概览
研究类型
介入性
注册 (实际的)
12
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
-
-
-
Gieres、法国
- Eurofins Optimed Clinical research
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-
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
20年 至 50年 (成人)
接受健康志愿者
是的
有资格学习的性别
男性
描述
Inclusion Criteria:
- Healthy males, Age at start of the study >20 and <50 years;
- Body mass index (BMI) ≥ 20,0 and ≤ 25,0 kg/m2;
- Apparently healthy: no medical conditions which might affect the study measurements, absorption, metabolism and distribution (including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery and inflammatory diseases);
- Fasting blood glucose value of subjects is ≥ 3.4 and ≤ 6.1 mmol/litre (i.e. 62-110 mg/dl) at screening;
- Agreeing to be informed about medically relevant personal test-results by a physician;
- Informed consent signed;
- Willing to comply to study protocol during study;
- Covered by Health Insurance System and/or in compliance with the recommendations of National Law in force relating to biomedical research.
- Accessible veins on arms as determined by examination at screening.
Exclusion Criteria:
- Any history of diabetes, hyper- (or hypo-) glycemia or other disorder of glucose metabolism;
- Blood donation in the past 2 months;
- Reported participation in another nutritional or biomedical trial 3 months before the pre-study examination or during the study;
- Reported participation in night shift work two weeks prior to pre-study investigation or during the study. Night work is defined as working between midnight and 6.00 AM;
- Reported intense sporting activities > 10h/w;
- Consumption of > 21 alcoholic drinks in a typical week;
- Not being used to eat breakfast;
- Reported use of any nicotine containing products in the six months preceding the study and during the study itself;
- Use of medication which interferes with study measurements;
- Reported dietary habits: medically prescribed diet, slimming diet;
- Not used to eat 3 meals a day;
- Vegetarian;
- Reported weight loss/gain (>10%) in the last six month before the study;
- Being an employee of Unilever and CRO;
- Allergy or intolerance to food products and aversion to food products provided during the study;
- Subject who cannot be contacted in case of emergency;
- Subject who, in the judgment of the investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development;
- Subject under guardianship;
- Subject who would receive more than 4500 euro's as indemnities for his participation in biomedical research within the 12 last months, including the indemnities for the present study.
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:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他:Plant-based ingredient to a starchy meal
Plant-based ingredient
|
|
|
其他:Starchy meal alone
No plant-based ingredient
|
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 |
|---|---|---|
|
AUC of post-prandial hormones
大体时间:120 minutes
|
Amylin (total) will be assessed.
|
120 minutes
|
|
AUC of post-prandial hormones
大体时间:120 minutes
|
Ghrelin (active) will be assessed.
|
120 minutes
|
|
AUC of post-prandial hormones
大体时间:120 minutes
|
Glucose-dependent insulinotropic peptide (gastric inhibitory polypeptide, GIP) (total) will be assessed.
|
120 minutes
|
|
AUC of post-prandial hormones
大体时间:120 minutes
|
Glucagon-like peptide-1 (GLP-1) (active) will be assessed.
|
120 minutes
|
|
AUC of post-prandial hormones
大体时间:120 minutes
|
Leptin will be assessed.
|
120 minutes
|
|
AUC of post-prandial hormones
大体时间:120 minutes
|
Pancreatic polypeptide (PP) will be assessed.
|
120 minutes
|
|
AUC of post-prandial hormones
大体时间:120 minutes
|
Peptide YY (PYY) (total) will be assessed.
|
120 minutes
|
|
AUC of post-prandial hormones
大体时间:120 minutes
|
Insulin will be assessed.
|
120 minutes
|
|
AUC of post-prandial hormones
大体时间:120 minutes
|
C-peptide will be assessed.
|
120 minutes
|
|
AUC of post-prandial hormones
大体时间:120 minutes
|
Glucagon will be assessed.
|
120 minutes
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
AUC of post-prandial hormones
大体时间:180 and 240 minutes
|
Amylin (total) will be assessed.
|
180 and 240 minutes
|
|
AUC of post-prandial hormones
大体时间:180 and 240 minutes
|
Ghrelin (active) will be assessed.
|
180 and 240 minutes
|
|
AUC of post-prandial hormones
大体时间:180 and 240 minutes
|
Glucose-dependent insulinotropic peptide (gastric inhibitory polypeptide, GIP) (total) will be assessed.
|
180 and 240 minutes
|
|
AUC of post-prandial hormones
大体时间:180 and 240 minutes
|
Pancreatic polypeptide (PP) will be assessed.
|
180 and 240 minutes
|
|
AUC of post-prandial hormones
大体时间:180 and 240 minutes
|
Peptide YY (PYY) (total) will be assessed.
|
180 and 240 minutes
|
|
AUC of post-prandial hormones
大体时间:180 and 240 minutes
|
Leptin will be assessed.
|
180 and 240 minutes
|
|
AUC of post-prandial hormones
大体时间:180 and 240 minutes
|
Glucagon will be assessed.
|
180 and 240 minutes
|
|
AUC of post-prandial hormones
大体时间:180 and 240 minutes
|
Insulin will be assessed.
|
180 and 240 minutes
|
|
AUC of post-prandial hormones
大体时间:180 and 240 minutes
|
C-peptide will be assessed.
|
180 and 240 minutes
|
|
AUC of post-prandial hormones
大体时间:180 and 240 minutes
|
Glucagon-like peptide-1 (GLP-1) (active) will be assessed.
|
180 and 240 minutes
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Blood glucose response (+iAUC)
大体时间:120 and 180 minutes
|
Effect on blood glucose response.
|
120 and 180 minutes
|
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。
赞助
调查人员
- 首席研究员:Yves DONAZZOLO, M.D., M.Sc.、EUROFINS OPTIMED, GIERES - France
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
2013年12月1日
初级完成 (实际的)
2014年1月1日
研究完成 (实际的)
2014年1月1日
研究注册日期
首次提交
2013年11月22日
首先提交符合 QC 标准的
2013年12月5日
首次发布 (估计)
2013年12月6日
研究记录更新
最后更新发布 (估计)
2014年4月9日
上次提交的符合 QC 标准的更新
2014年4月8日
最后验证
2014年1月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- FDS-NAA-1462
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.