Effects of Bread Gluten Content on Gastrointestinal Volumes
Not Applicable
Completed
- Conditions
- Healthy
- Interventions
- Other: MRI scannersOther: VAS Symptom scores
- Registration Number
- NCT02104115
- Lead Sponsor
- University of Nottingham
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Gluten free white bread VAS Symptom scores Sliced loaf of gluten free white bread High gluten content white wheat bread VAS Symptom scores Sliced loaf of high gluten content white wheat bread Gluten free white bread MRI scanners Sliced loaf of gluten free white bread Normal gluten content white wheat bread VAS Symptom scores Sliced loaf of normal gluten content white wheat bread High gluten content white wheat bread MRI scanners Sliced loaf of high gluten content white wheat bread Normal gluten content white wheat bread MRI scanners Sliced loaf of normal gluten content white wheat bread
- Primary Outcome Measures
Name Time Method Change in gastric volume from baseline to 360 minutes after feeding baseline and 0, 60, 120, 180, 240, 300, 360 minutes after feeding
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
Sir Peter Mansfield Magnetic Resonance Centre, University of Nottingham
🇬🇧Nottingham, United Kingdom
Nottingham Digestive Diseases Centre, E floor West Block, QMC Campus, Nottingham University Hospitals
🇬🇧Nottingham, United Kingdom