Effects of Bread Gluten Content on Gastrointestinal Volumes

Study Overview
=================
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.

Official Title
-----------------
Effects of Bread Gluten Content on Gastrointestinal Volumes

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: MRI scanners
* Other: VAS Symptom scores


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Gluten free white bread<br>Sliced loaf of gluten free white bread | Other: MRI scanners<br> <br> Other: VAS Symptom scores<br> <br> |
| Other: Normal gluten content white wheat bread<br>Sliced loaf of normal gluten content white wheat bread | Other: MRI scanners<br> <br> Other: VAS Symptom scores<br> <br> |
| Other: High gluten content white wheat bread<br>Sliced loaf of high gluten content white wheat bread | Other: MRI scanners<br> <br> Other: VAS Symptom scores<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stomach, Small bowel, Function, Gastrointestinal volumes, Colon, MRI