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Effects of Bread Gluten Content on Gastrointestinal Volumes

Effects of Bread Gluten Content on Gastrointestinal Volumes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02104115
Acronym
EGG
Enrollment
15
Registered
2014-04-04
Start date
2014-03-31
Completion date
2014-08-31
Last updated
2015-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Stomach, Small bowel, Colon, MRI, Function, Gastrointestinal volumes

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.

Interventions

OTHERMRI scanners
OTHERVAS Symptom scores

Sponsors

University of Nottingham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Change in gastric volume from baseline to 360 minutes after feedingbaseline and 0, 60, 120, 180, 240, 300, 360 minutes after feeding

Secondary

MeasureTime frame
Change in small bowel water content from baseline to 360 minutes after feedingbaseline and 0, 60, 120, 180, 240, 300, 360 minutes after feeding

Other

MeasureTime frame
Change in colonic total volume from baseline to 360 minutes after feedingbaseline 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 feedingbaseline, 0, 60, 120, 180, 240, 300, 360 minutes after feeding
Change in colonic gas volumes from baseline to 360 minutes after feedingbaseline and 0, 60, 120, 180, 240, 300, 360 minutes after feeding

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026