NCT02104115

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 4, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

October 6, 2015

Status Verified

October 1, 2015

Enrollment Period

4 months

First QC Date

March 25, 2014

Last Update Submit

October 5, 2015

Conditions

Healthy

Keywords

StomachSmall bowelColonMRIFunctionGastrointestinal volumes

Outcome Measures

Primary Outcomes (1)

  • Change in gastric volume from baseline to 360 minutes after feeding

    baseline and 0, 60, 120, 180, 240, 300, 360 minutes after feeding

Secondary Outcomes (1)

  • 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

Other Outcomes (3)

  • Change in colonic total volume from baseline to 360 minutes after feeding

    baseline and 0, 60, 120, 180, 240, 300, 360 minutes after feeding

  • 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

  • Change in colonic gas volumes from baseline to 360 minutes after feeding

    baseline and 0, 60, 120, 180, 240, 300, 360 minutes after feeding

Study Arms (3)

Gluten free white bread

OTHER

Sliced loaf of gluten free white bread

Other: MRI scannersOther: VAS Symptom scores

Normal gluten content white wheat bread

OTHER

Sliced loaf of normal gluten content white wheat bread

Other: MRI scannersOther: VAS Symptom scores

High gluten content white wheat bread

OTHER

Sliced loaf of high gluten content white wheat bread

Other: MRI scannersOther: VAS Symptom scores

Interventions

MRI scannersOTHER
Gluten free white breadHigh gluten content white wheat breadNormal gluten content white wheat bread
VAS Symptom scoresOTHER
Gluten free white breadHigh gluten content white wheat breadNormal gluten content white wheat bread

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18-55
  • Able to give informed consent

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sir Peter Mansfield Magnetic Resonance Centre, University of Nottingham

Nottingham, NG7 2RD, United Kingdom

Location

Nottingham Digestive Diseases Centre, E floor West Block, QMC Campus, Nottingham University Hospitals

Nottingham, NG7 2UH, United Kingdom

Location

Related Publications (5)

  • 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.

    PMID: 21276139BACKGROUND

  • 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.

    PMID: 23594839BACKGROUND

  • 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.

    PMID: 19500889BACKGROUND

  • 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.

    PMID: 18029983BACKGROUND

  • 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.

    PMID: 19909743BACKGROUND

Study Officials

  • Marina Coletta, Fellow in Gastroenterology

    Visiting fellow in Gastroenterology

    PRINCIPAL INVESTIGATOR

  • Luca Marciani, Lecturer

    Lecturer in Gastrointestinal Imaging

    PRINCIPAL INVESTIGATOR

  • Robin Spiller, Professor

    Professor of Gastroenterology

    STUDY DIRECTOR

  • Giles Major, Fellow

    University of Nottingham

    PRINCIPAL INVESTIGATOR

  • Gemma Chaddock, BSc

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2014

First Posted

April 4, 2014

Study Start

March 1, 2014

Primary Completion

July 1, 2014

Study Completion

August 1, 2014

Last Updated

October 6, 2015

Record last verified: 2015-10

Locations

GB(2)