Glycemic and Insulinemic Impact of Selected Canadian Beans (MED-beans)
2016年9月19日 更新者:Dan Ramdath、Guelph Food Research Centre
The objective of this study is to compare the glycemic and insulinemic response elicited by ½ cup servings of 6 beans to those elicited by ½ cup servings of mashed potato, macaroni, rice and corn.
研究概览
详细说明
In order for a food to be able to claim a reduced glycemic response, it must be shown that a typical serving of the food elicits a significantly lower blood glucose responses compared to a serving of an appropriate control food.
While many studies have examined the GI of beans, few studies have compared the glycemic impact of a typical serving of beans to a typical serving of other starchy foods.
Therefore, there are insufficient data to allow for a claim that beans have a low glycemic response.
In addition, in order to make a claim of a reduced glycemic response, regulatory agencies also require that the insulinemic response to a food is not disproportionately increased.
研究类型
介入性
注册 (实际的)
18
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
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Ontario
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Toronto、Ontario、加拿大、M5C 2N8
- Glycemic Index Laboratories, Inc
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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
18年 至 75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:
- Male or non-pregnant females, 18-75 years of age, inclusive
- Body mass index (BMI) < 40 kg/m²
- Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial and to refrain from smoking for 12hr prior to each visit.
- Normal fasting serum glucose (<7.0mmol/L capillary corresponding to whole blood glucose <6.3mmol/L).
- Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator.
Exclusion Criteria:
- Failure to meet any one of the inclusion criteria
- Known history of AIDS, hepatitis, diabetes or a heart condition
- Subjects using medications or with any condition which might, in the opinion of Dr. Wolever, the Medical Director of GI Labs, either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
- Major trauma or surgical event within 3 months of screening.
- Unwillingness or inability to comply with the experimental procedures and to follow GI Labs safety guidelines.
- Known intolerance, sensitivity or allergy to any ingredients in the study products.
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:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Bean Type
Beans (black; cranberry; great northern; navy; pinto; red) soaked overnight and boiled.
1/2 cup serving eaten by participants at study visit
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1/2 cup of freshly boiled beans will be eaten by participants on separate study visits
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有源比较器:Starchy Foods
1/2 cup serving of rice or paste or potato or corn will be eaten by participants on different study visit
|
1/2 cup serving of one of 4 starchy foods will be eaten by participants on different study visit
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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 |
---|---|---|
Glycemic Response
大体时间:120 minutes
|
post prandial blood glucose response
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120 minutes
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Insulin Response
大体时间:120 minutes
|
post prandial blood insulin response
|
120 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。
调查人员
- 首席研究员:Dan Ramdath, PhD、GI Laboratories Inc.
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。
一般刊物
- Wolever TM, Jenkins DJ. The use of the glycemic index in predicting the blood glucose response to mixed meals. Am J Clin Nutr. 1986 Jan;43(1):167-72. doi: 10.1093/ajcn/43.1.167.
- Wolever TMS (2006). The Glycaemic Index: A Physiological Classification of Dietary Carbohydrate. CABI Publishing, Wallingford, UK.
- Ramdath D, Renwick S, Duncan AM. The Role of Pulses in the Dietary Management of Diabetes. Can J Diabetes. 2016 Aug;40(4):355-63. doi: 10.1016/j.jcjd.2016.05.015.
- EFSA 2011: European Food Safety Authority, Scientific Opinion on the substantiation of health claims related to resistant starch and reduction of post-prandial glycaemic responses (ID 681), "digestive health benefits" (ID 682) and "favours a normal colon metabolism" (ID 783) pursuant to Article 13(1) of Regulation (EC) No 1924/20061. EFSA Journal 9(4):2024.
- EFSA: European Food Safety Authority, Panel on Dietetic Products, Nutrition and Allergies (NDA). 2012. Scientific Opinion. Guidance on the scientific requirements for health claims related to appetite ratings, weight management and blood glucose concentrations. EFSA Journal 10(3): 2604-2614.
- Health Canada. Bureau of Nutritional Sciences, food directorate, health products and food branch. June 2013. Draft guidance document on food health claims related to the reduction in post-prandial glycaemic response.
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
2016年3月1日
初级完成 (实际的)
2016年9月1日
研究完成 (实际的)
2016年9月1日
研究注册日期
首次提交
2016年9月15日
首先提交符合 QC 标准的
2016年9月19日
首次发布 (估计)
2016年9月20日
研究记录更新
最后更新发布 (估计)
2016年9月20日
上次提交的符合 QC 标准的更新
2016年9月19日
最后验证
2016年9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.
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-
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