Effects of Bread Gluten Content on Gastrointestinal Volumes

Healthy Clinical Trial

— EGG  

Official title:

Effects of Bread Gluten Content on Gastrointestinal Volumes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02104115
• Other study ID #: E12122013 SoM NDDC EEG
• Status: Completed
• Phase: N/A
• First received: March 25, 2014
• Last updated: October 5, 2015
• Start date: March 2014
• Est. completion date: August 2014

Study information

• Verified date: October 2015
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• MRI scanners

• VAS Symptom scores

Locations

Country	Name	City	State
United Kingdom	Nottingham Digestive Diseases Centre, E floor West Block, QMC Campus, Nottingham University Hospitals	Nottingham
United Kingdom	Sir Peter Mansfield Magnetic Resonance Centre, University of Nottingham	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

References & Publications (5)

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. Epub 2007 Nov 8. — View 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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in colonic total volume from baseline to 360 minutes after feeding		baseline and 0, 60, 120, 180, 240, 300, 360 minutes after feeding	No
Other	Change in VAS for symptom scores (fullness, hunger, desire to eat, bloating, nausea, abdominal discomfort / pain) from baseline to 360 minutes after feeding		baseline, 0, 60, 120, 180, 240, 300, 360 minutes after feeding	Yes
Other	Change in colonic gas volumes from baseline to 360 minutes after feeding		baseline and 0, 60, 120, 180, 240, 300, 360 minutes after feeding	No
Primary	Change in gastric volume from baseline to 360 minutes after feeding		baseline and 0, 60, 120, 180, 240, 300, 360 minutes after feeding	No
Secondary	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	No