Clinical trial NCT02104115: Effects of Bread Gluten Content on Gastrointestinal Volumes
Official title: Effects of Bread Gluten Content on Gastrointestinal Volumes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Stomach
Small bowel
Colon
MRI
Function
Gastrointestinal volumes
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2014-04-04
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in gastric volume from baseline to 360 minutes after feeding
timeFrame: baseline and 0, 60, 120, 180, 240, 300, 360 minutes after feeding
Secondary outcomes:
measure: Change in small bowel water content from baseline to 360 minutes after feeding
timeFrame: baseline and 0, 60, 120, 180, 240, 300, 360 minutes after feeding
Other outcomes:
measure: Change in colonic total volume from baseline to 360 minutes after feeding
timeFrame: baseline and 0, 60, 120, 180, 240, 300, 360 minutes after feeding
measure: Change in VAS for symptom scores (fullness, hunger, desire to eat, bloating, nausea, abdominal discomfort / pain) from baseline to 360 minutes after feeding
timeFrame: baseline, 0, 60, 120, 180, 240, 300, 360 minutes after feeding
measure: Change in colonic gas volumes from baseline to 360 minutes after feeding
timeFrame: baseline and 0, 60, 120, 180, 240, 300, 360 minutes after feeding
Locations:
city: Nottingham
country: United Kingdom
facility: Sir Peter Mansfield Magnetic Resonance Centre, University of Nottingham
city: Nottingham
country: United Kingdom
facility: Nottingham Digestive Diseases Centre, E floor West Block, QMC Campus, Nottingham University Hospitals
Study officials:
affiliation: Visiting fellow in Gastroenterology
name: Marina Coletta, Fellow in Gastroenterology
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer in Gastrointestinal Imaging
name: Luca Marciani, Lecturer
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Gastroenterology
name: Robin Spiller, Professor
role: STUDY_DIRECTOR
affiliation: University of Nottingham
name: Giles Major, Fellow
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nottingham
name: Gemma Chaddock, BSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.