Effects of Bread Gluten Content on Gastrointestinal Volumes (EGG)
2015年10月5日 更新者:University of Nottingham
The investigators will apply non invasive Magnetic Resonance Imaging (MRI) techniques developed in Nottingham to evaluate the gastric emptying, small bowel water content, colonic gas and volumes in healthy volunteers eating three breads with different amount of gluten (none, normal, or high gluten) in three consecutive weeks.
研究概览
研究类型
介入性
注册 (实际的)
15
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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Nottingham、英国、NG7 2RD
- Sir Peter Mansfield Magnetic Resonance Centre, University of Nottingham
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Nottingham、英国、NG7 2UH
- Nottingham Digestive Diseases Centre, E floor West Block, QMC Campus, Nottingham University Hospitals
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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 55年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Aged 18-55
- Able to give informed consent
Exclusion Criteria:
- Unable to abstain from smoking for the duration of the study
- Pregnancy declared by candidate
- History declared by the candidate of pre-existing gastrointestinal disorder, including but not limited to: Inflammatory Bowel Disease, Coeliac Disease, Pancreatitis, Gallstone disease (biliary colic, cholecystitis), Diverticulitis, Cancer of the gastrointestinal tract, Irritable Bowel Syndrome
- Reported history of previous resection of any part of the gastrointestinal tract other than appendix or gallbladder
- Any medical condition making participation potentially compromising participation in the study e.g. diabetes mellitus, respiratory disease limiting ability to lie in the scanner
- Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury
- Reported alcohol dependence
- Taking any drug known to alter GI motility including mebeverine, opiates, monoamine oxidase inhibitors, phenothiazines, benzodiazepines, calcium channel antagonists during or in the 2 weeks prior to the test. (Selective serotonin reuptake inhibitors and low dose tricyclic antidepressants will be recorded but will not be an exclusion criteria)
- Antibiotic or probiotic treatment in the past 4 weeks
- Inability to lie flat or exceed scanner limits of weight <120kg
- Poor understanding of English language
- Participation in night shift work the week prior to the study day. Night work is defined as working between midnight and 0600
- Strenuous exercise greater than 10 hours per week (i.e. no competition training the week prior to the study).
- Participation in any medical trials for the past 3 months
- Anyone who in the opinion of the investigator is unlikely to be able to comply with the protocol e.g. cognitive dysfunction, chaotic lifestyle related to substance abuse
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:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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其他:Gluten free white bread
Sliced loaf of gluten free white bread
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其他:Normal gluten content white wheat bread
Sliced loaf of normal gluten content white wheat bread
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其他:High gluten content white wheat bread
Sliced loaf of high gluten content white wheat bread
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Change in gastric volume from baseline to 360 minutes after feeding
大体时间:baseline and 0, 60, 120, 180, 240, 300, 360 minutes after feeding
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baseline and 0, 60, 120, 180, 240, 300, 360 minutes after feeding
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次要结果测量
结果测量 |
大体时间 |
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Change in small bowel water content from baseline to 360 minutes after feeding
大体时间:baseline and 0, 60, 120, 180, 240, 300, 360 minutes after feeding
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baseline and 0, 60, 120, 180, 240, 300, 360 minutes after feeding
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其他结果措施
结果测量 |
大体时间 |
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Change in colonic total volume from baseline to 360 minutes after feeding
大体时间:baseline and 0, 60, 120, 180, 240, 300, 360 minutes after feeding
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baseline and 0, 60, 120, 180, 240, 300, 360 minutes after feeding
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Change in VAS for symptom scores (fullness, hunger, desire to eat, bloating, nausea, abdominal discomfort / pain) from baseline to 360 minutes after feeding
大体时间:baseline, 0, 60, 120, 180, 240, 300, 360 minutes after feeding
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baseline, 0, 60, 120, 180, 240, 300, 360 minutes after feeding
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Change in colonic gas volumes from baseline to 360 minutes after feeding
大体时间:baseline and 0, 60, 120, 180, 240, 300, 360 minutes after feeding
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baseline and 0, 60, 120, 180, 240, 300, 360 minutes after feeding
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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。
调查人员
- 首席研究员:Marina Coletta, Fellow in Gastroenterology、Visiting fellow in Gastroenterology
- 首席研究员:Luca Marciani, Lecturer、Lecturer in Gastrointestinal Imaging
- 研究主任:Robin Spiller, Professor、Professor of Gastroenterology
- 首席研究员:Giles Major, Fellow、University of Nottingham
- 首席研究员:Gemma Chaddock, BSc、University of Nottingham
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
- Marciani L, Cox EF, Hoad CL, Pritchard S, Totman JJ, Foley S, Mistry A, Evans S, Gowland PA, Spiller RC. Postprandial changes in small bowel water content in healthy subjects and patients with irritable bowel syndrome. Gastroenterology. 2010 Feb;138(2):469-77, 477.e1. doi: 10.1053/j.gastro.2009.10.055. Epub 2009 Nov 10.
- Hoad CL, Marciani L, Foley S, Totman JJ, Wright J, Bush D, Cox EF, Campbell E, Spiller RC, Gowland PA. Non-invasive quantification of small bowel water content by MRI: a validation study. Phys Med Biol. 2007 Dec 7;52(23):6909-22. doi: 10.1088/0031-9155/52/23/009. Epub 2007 Nov 8.
- Marciani L. Assessment of gastrointestinal motor functions by MRI: a comprehensive review. Neurogastroenterol Motil. 2011 May;23(5):399-407. doi: 10.1111/j.1365-2982.2011.01670.x. Epub 2011 Jan 30.
- Lobo DN, Hendry PO, Rodrigues G, Marciani L, Totman JJ, Wright JW, Preston T, Gowland P, Spiller RC, Fearon KC. Gastric emptying of three liquid oral preoperative metabolic preconditioning regimens measured by magnetic resonance imaging in healthy adult volunteers: a randomised double-blind, crossover study. Clin Nutr. 2009 Dec;28(6):636-41. doi: 10.1016/j.clnu.2009.05.002. Epub 2009 Jun 4.
- Marciani L, Pritchard SE, Hellier-Woods C, Costigan C, Hoad CL, Gowland PA, Spiller RC. Delayed gastric emptying and reduced postprandial small bowel water content of equicaloric whole meal bread versus rice meals in healthy subjects: novel MRI insights. Eur J Clin Nutr. 2013 Jul;67(7):754-8. doi: 10.1038/ejcn.2013.78. Epub 2013 Apr 17.
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
2014年3月1日
初级完成 (实际的)
2014年7月1日
研究完成 (实际的)
2014年8月1日
研究注册日期
首次提交
2014年3月25日
首先提交符合 QC 标准的
2014年3月31日
首次发布 (估计)
2014年4月4日
研究记录更新
最后更新发布 (估计)
2015年10月6日
上次提交的符合 QC 标准的更新
2015年10月5日
最后验证
2015年10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.
MRI scanners的临床试验
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Memorial Sloan Kettering Cancer CenterNational Institutes of Health (NIH)主动,不招人
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Memorial Sloan Kettering Cancer Center终止
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Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)终止
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Memorial Sloan Kettering Cancer Center主动,不招人