NCT02104115已完成不适用
Effects of Bread Gluten Content on Gastrointestinal Volumes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Change in gastric volume from baseline to 360 minutes after feeding
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18-55
- •Able to give informed consent
排除标准
- •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
结局指标
主要结局
Change in gastric volume from baseline to 360 minutes after feeding
时间窗: baseline and 0, 60, 120, 180, 240, 300, 360 minutes after feeding
次要结局
- Change in small bowel water content from baseline to 360 minutes after feeding(baseline and 0, 60, 120, 180, 240, 300, 360 minutes after feeding)
研究者
研究点 (4)
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