A Low-osmolaric Glucose Polymer Drink for Gastric Distress and Running Performance
2015年12月14日 更新者：Jeroen Wouters、InnoSportNL
The Effect of a Potato Based Low-osmolaric Glucose Polymer Drink on Gastric Distress and Running Performance
The objective of this study is to investigate whether two newly developed sports drink will affect gastric distress (GD) and running performance (RP) compared to an iso-caloric control drink both in a short and longer distance run. Furthermore, the effect of the newly developed sports drinks on gastric emptying will be investigated.
The study will consist of 3 parts. Firstly, a randomized cross-over design is used for the short distance run and the effects on GD and RP. Secondly, a parallel design is used to study the effects of the drinks on GD and RP during a longer distance run. Thirdly, the gastric emptying tests will be performed in a randomized cross-over design. Participants will be asked to fill in questionnaire on the gastric distress they experience. 40 participants will be enrolled to participate in part 1 and part 2. 10 out of 40 will participate in part 3 of the study.
研究概览
研究类型
介入性
注册 (实际的)
43
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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Gelderland
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Arnhem、Gelderland、荷兰、6816VD
- InnoSportLab Papendal
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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 35年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age between 18 and 35 years
- A BMI between 18.5 and 25 kg*m-2
- Intermediate level runners with at least 1 year of running experience, performing moderate to intensive running exercise consistently (two or more times per week for a minimum of 30 minutes each time)
Exclusion Criteria:
- Pregnancy
- Having diseases, such as diabetes, kidney, liver, lung, or bowel disease, cardiovascular disease, or mental illness
- Abuse of alcohol (>20 alcoholic consumptions per week)
- Use of medication and/or drugs
- Smoking/having smoked in the last six months
- Participating in any scientific intervention providing a treatment potentially interfering with this study's treatment (to be decided by the researchers)
- Allergic to one of the components present in the drinks, including milk (incl. lactose), soy and gluten
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
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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安慰剂比较：Placebo group
Sports drink containing maltodextrin
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iso-caloric sports drink with maltodextrin as CHO source
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有源比较器：Sports drink 1
Sports drink with a specific source of carbohydrates (CHO).
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Sports drink with a specific source of CHO.
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有源比较器：Sports drink 2
Sports drink with a specific source of CHO.
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Sports drink with a specific source of CHO
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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 |
|---|---|---|
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Perceived degree of gastric complaints after consumption of sports drink and running exercise
大体时间：Approximately 10-20 minutes for the 3 km and 40-60 minutes for the 10 km.
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Quantified as the score for the perceived degree of experiencing 7 different gastric complaints on a VAS.
The total score for gastric distress and the scores for each different gastric complaint will be analysed separately for the three different time points (before, during and after exercise).
The total score is the sum of the scores on the separate complaints.
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Approximately 10-20 minutes for the 3 km and 40-60 minutes for the 10 km.
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Finishing time during 10 km running event
大体时间：Depending on the speed of the participant, an average time frame of 40-60 minutes after starting the run is expected.
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Depending on the speed of the participant, an average time frame of 40-60 minutes after starting the run is expected.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Rate of gastric emptying
大体时间：1 hour after ingestion of sports drink
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During 1 hour after ingestion of the sports drink, subjects will breath into a specific bag which will be analysed for the presence of C13 on specific time points.
The decrease of C13 in the exhaled air is a measurement for gastric emptying time.
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1 hour after ingestion of sports drink
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Blood glucose levels
大体时间：During 1 hour after ingestion of sports drink
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On specific time points within 1 hour after ingestion of the sports drink, blood glucose levels will be determined to calculate area under the curve for the different sport drinks.
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During 1 hour after ingestion of sports drink
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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。
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
- Leiper JB, Aulin KP, Soderlund K. Improved gastric emptying rate in humans of a unique glucose polymer with gel-forming properties. Scand J Gastroenterol. 2000 Nov;35(11):1143-9. doi: 10.1080/003655200750056600.
- Takii H, Takii Nagao Y, Kometani T, Nishimura T, Nakae T, Kuriki T, Fushiki T. Fluids containing a highly branched cyclic dextrin influence the gastric emptying rate. Int J Sports Med. 2005 May;26(4):314-9. doi: 10.1055/s-2004-820999.
- Stephens FB, Roig M, Armstrong G, Greenhaff PL. Post-exercise ingestion of a unique, high molecular weight glucose polymer solution improves performance during a subsequent bout of cycling exercise. J Sports Sci. 2008 Jan 15;26(2):149-54. doi: 10.1080/02640410701361548.
- Rehrer NJ, Brouns F, Beckers EJ, ten Hoor F, Saris WH. Gastric emptying with repeated drinking during running and bicycling. Int J Sports Med. 1990 Jun;11(3):238-43. doi: 10.1055/s-2007-1024799.
- Moses FM. The effect of exercise on the gastrointestinal tract. Sports Med. 1990 Mar;9(3):159-72. doi: 10.2165/00007256-199009030-00004.
- de Oliveira EP, Burini RC. Food-dependent, exercise-induced gastrointestinal distress. J Int Soc Sports Nutr. 2011 Sep 28;8:12. doi: 10.1186/1550-2783-8-12.
- Ploutz-Snyder L, Foley J, Ploutz-Snyder R, Kanaley J, Sagendorf K, Meyer R. Gastric gas and fluid emptying assessed by magnetic resonance imaging. Eur J Appl Physiol Occup Physiol. 1999 Feb;79(3):212-20. doi: 10.1007/s004210050498.
- Rodriguez NR, DiMarco NM, Langley S; American Dietetic Association; Dietitians of Canada; American College of Sports Medicine: Nutrition and Athletic Performance. Position of the American Dietetic Association, Dietitians of Canada, and the American College of Sports Medicine: Nutrition and athletic performance. J Am Diet Assoc. 2009 Mar;109(3):509-27. doi: 10.1016/j.jada.2009.01.005. Erratum In: J Am Diet Assoc. 2013 Dec;113(12):1759.
- American Dietetic Association; Dietitians of Canada; American College of Sports Medicine, Rodriguez NR, Di Marco NM, Langley S. American College of Sports Medicine position stand. Nutrition and athletic performance. Med Sci Sports Exerc. 2009 Mar;41(3):709-31. doi: 10.1249/MSS.0b013e31890eb86.
- Murray R, Bartoli W, Stofan J, Horn M, Eddy D. A comparison of the gastric emptying characteristics of selected sports drinks. Int J Sport Nutr. 1999 Sep;9(3):263-74. doi: 10.1123/ijsn.9.3.263.
- Maughan RJ, Leiper JB. Limitations to fluid replacement during exercise. Can J Appl Physiol. 1999 Apr;24(2):173-87. doi: 10.1139/h99-015.
- Rowlands DS, Wallis GA, Shaw C, Jentjens RL, Jeukendrup AE. Glucose polymer molecular weight does not affect exogenous carbohydrate oxidation. Med Sci Sports Exerc. 2005 Sep;37(9):1510-6. doi: 10.1249/01.mss.0000177586.68399.f5.
- Zhu Y, Hsu WH, Hollis JH. The impact of food viscosity on eating rate, subjective appetite, glycemic response and gastric emptying rate. PLoS One. 2013 Jun 20;8(6):e67482. doi: 10.1371/journal.pone.0067482. Print 2013.
- Siegel JA, Krevsky B, Maurer AH, Charkes ND, Fisher RS, Malmud LS. Scintigraphic evaluation of gastric emptying: are radiolabeled solids necessary? Clin Nucl Med. 1989 Jan;14(1):40-6. doi: 10.1097/00003072-198901000-00011.
- Chang TM, Passaro E Jr, Shain LR, Chen WL. Physical properties of starch meals in vivo and in vitro and their influence on gastric emptying and oral glucose tolerance test. Nutrition. 1991 Nov-Dec;7(6):410-6.
- Mourot J, Thouvenot P, Couet C, Antoine JM, Krobicka A, Debry G. Relationship between the rate of gastric emptying and glucose and insulin responses to starchy foods in young healthy adults. Am J Clin Nutr. 1988 Oct;48(4):1035-40. doi: 10.1093/ajcn/48.4.1035.
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2月1日
初级完成 (实际的)
2015年9月1日
研究完成 (实际的)
2015年9月1日
研究注册日期
首次提交
2015年3月9日
首先提交符合 QC 标准的
2015年3月23日
首次发布 (估计)
2015年3月27日
研究记录更新
最后更新发布 (估计)
2015年12月15日
上次提交的符合 QC 标准的更新
2015年12月14日
最后验证
2015年12月1日
更多信息
与本研究相关的术语
其他研究编号
- LOGP-001
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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Mila (bMotion Technologies)完全的