Effects of Bread Gluten Content on Gastrointestinal Volumes (EGG)

University of Nottingham

Status: Completed

Conditions: Healthy

Treatments: Other: MRI scanners; Other: VAS Symptom scores

Study type: Interventional

Funder types: Other

Identifiers

NCT02104115

E12122013 SoM NDDC EEG

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

15 participants in 3 patient groups

Gluten free white bread

Other group

Description:

Sliced loaf of gluten free white bread

Treatment:

Other: MRI scanners

Other: VAS Symptom scores

Normal gluten content white wheat bread

Other group

Description:

Sliced loaf of normal gluten content white wheat bread

Treatment:

Other: MRI scanners

Other: VAS Symptom scores

High gluten content white wheat bread

Other group

Description:

Sliced loaf of high gluten content white wheat bread

Treatment:

Other: MRI scanners

Other: VAS Symptom scores