HealthyEGGNCT02104115
Effects of Bread Gluten Content on Gastrointestinal Volumes
A study testing MRI scanners and VAS Symptom scores in people with Healthy, run by University of Nottingham at 2 sites in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MRI scanners and VAS Symptom scores
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Mar 2014to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-55
- Able to give informed consent
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Sir Peter Mansfield Magnetic Resonance Centre, University of Nottingham
Nottingham, NG7 2RD
Nottingham Digestive Diseases Centre, E floor West Block, QMC Campus, Nottingham University Hospitals
Nottingham, NG7 2UH
About this study
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.
- Conditions
- Healthy
- Being tested
- MRI scanners, VAS Symptom scores
- Keywords
- Stomach, Small bowel, Colon, MRI, Function, Gastrointestinal volumes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scannersOther
VAS Symptom scoresOther
| Study group | Role | What they receive |
|---|---|---|
| Gluten free white bread | Other | Sliced loaf of gluten free white bread Receives: Other: MRI scanners; Other: VAS Symptom scores |
| Normal gluten content white wheat bread | Other | Sliced loaf of normal gluten content white wheat bread Receives: Other: MRI scanners; Other: VAS Symptom scores |
| High gluten content white wheat bread | Other | Sliced loaf of high gluten content white wheat bread Receives: Other: MRI scanners; Other: VAS Symptom scores |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gastric volume from baseline to 360 minutes after feeding
Measured: 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
Measured: baseline and 0, 60, 120, 180, 240, 300, 360 minutes after feeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionJul 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marina Coletta, Fellow in Gastroenterology, Principal investigator, Visiting fellow in GastroenterologyLuca Marciani, Lecturer, Principal investigator, Lecturer in Gastrointestinal ImagingRobin Spiller, Professor, Study director, Professor of GastroenterologyGiles Major, Fellow, Principal investigator, University of NottinghamGemma Chaddock, BSc, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02104115
- Sponsor's protocol ID
- E12122013 SoM NDDC EEG
- Acronym
- EGG
- Status last verified
- Oct 2015
- First submitted
- 25 Mar 2014
- Last updated
- 6 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21276139Marciani 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.
PubMed 23594839Lobo 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.
PubMed 19500889Hoad 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.
PubMed 18029983Marciani 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.
PubMed 19909743
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bread Gluten Content on Gastrointestinal Volumes
- ClinicalTrials.gov ID
- NCT02104115
- Acronym / sponsor ID
- EGG / E12122013 SoM NDDC EEG
- Conditions
- Healthy
- Keywords
- Stomach, Small bowel, Colon, MRI, Function, Gastrointestinal volumes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 4 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gluten free white bread | Other | Other: MRI scanners, Other: VAS Symptom scoresSliced loaf of gluten free white bread |
| Normal gluten content white wheat bread | Other | Other: MRI scanners, Other: VAS Symptom scoresSliced loaf of normal gluten content white wheat bread |
| High gluten content white wheat bread | Other | Other: MRI scanners, Other: VAS Symptom scoresSliced loaf of high gluten content white wheat bread |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Aged 18-55
- Able to give informed consent
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI scanners | Other | Gluten free white bread, High gluten content white wheat bread, Normal gluten content white wheat bread |
| VAS Symptom scores | Other | Gluten free white bread, High gluten content white wheat bread, Normal gluten content white wheat bread |
Primary outcome
Change in gastric volume from baseline to 360 minutes after feeding
Time frame: baseline and 0, 60, 120, 180, 240, 300, 360 minutes after feeding
1 secondary outcome
Change in small bowel water content from baseline to 360 minutes after feeding
Time frame: baseline and 0, 60, 120, 180, 240, 300, 360 minutes after feeding
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2015.
- Background: PubMed 21276139Marciani 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.
- Background: PubMed 23594839Marciani 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.
- Background: PubMed 19500889Lobo 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.
- Background: PubMed 18029983Hoad 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.
- Background: PubMed 19909743Marciani 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marina Coletta, Fellow in Gastroenterology principal investigator
Visiting fellow in Gastroenterology
Luca Marciani, Lecturer principal investigator
Lecturer in Gastrointestinal Imaging
Robin Spiller, Professor study director
Professor of Gastroenterology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI scanners and VAS Symptom scores in people with Healthy, run by University of Nottingham at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gastric volume from baseline to 360 minutes after feeding (time frame: baseline and 0, 60, 120, 180, 240, 300, 360 minutes after feeding). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02104115, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2015.