Effects of Bread Gluten Content on Gastrointestinal Volumes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Gluten free white bread

Sliced loaf of gluten free white bread

Group Type OTHER

MRI scanners

Intervention Type OTHER

VAS Symptom scores

Intervention Type OTHER

Normal gluten content white wheat bread

Sliced loaf of normal gluten content white wheat bread

Group Type OTHER

MRI scanners

Intervention Type OTHER

VAS Symptom scores

Intervention Type OTHER

High gluten content white wheat bread

Sliced loaf of high gluten content white wheat bread

Group Type OTHER

MRI scanners

Intervention Type OTHER

VAS Symptom scores

Intervention Type OTHER

Interventions

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MRI scanners

Intervention Type OTHER

VAS Symptom scores

Intervention Type OTHER

Eligibility Criteria

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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
* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes