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Effects of Bread Gluten Content on Gastrointestinal Volumes (EGG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02104115
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : October 6, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Other: MRI scanners Other: VAS Symptom scores Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Effects of Bread Gluten Content on Gastrointestinal Volumes
Study Start Date : March 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : August 2014

Arm Intervention/treatment
Gluten free white bread
Sliced loaf of gluten free white bread
Other: MRI scanners
Other: VAS Symptom scores
Normal gluten content white wheat bread
Sliced loaf of normal gluten content white wheat bread
Other: MRI scanners
Other: VAS Symptom scores
High gluten content white wheat bread
Sliced loaf of high gluten content white wheat bread
Other: MRI scanners
Other: VAS Symptom scores



Primary Outcome Measures :
  1. Change in gastric volume from baseline to 360 minutes after feeding [ Time Frame: baseline and 0, 60, 120, 180, 240, 300, 360 minutes after feeding ]

Secondary Outcome Measures :
  1. Change in small bowel water content from baseline to 360 minutes after feeding [ Time Frame: baseline and 0, 60, 120, 180, 240, 300, 360 minutes after feeding ]

Other Outcome Measures:
  1. Change in colonic total volume from baseline to 360 minutes after feeding [ Time Frame: baseline and 0, 60, 120, 180, 240, 300, 360 minutes after feeding ]
  2. Change in VAS for symptom scores (fullness, hunger, desire to eat, bloating, nausea, abdominal discomfort / pain) from baseline to 360 minutes after feeding [ Time Frame: baseline, 0, 60, 120, 180, 240, 300, 360 minutes after feeding ]
  3. Change in colonic gas volumes from baseline to 360 minutes after feeding [ Time Frame: baseline and 0, 60, 120, 180, 240, 300, 360 minutes after feeding ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104115


Locations
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United Kingdom
Sir Peter Mansfield Magnetic Resonance Centre, University of Nottingham
Nottingham, United Kingdom, NG7 2RD
Nottingham Digestive Diseases Centre, E floor West Block, QMC Campus, Nottingham University Hospitals
Nottingham, United Kingdom, NG7 2UH
Sponsors and Collaborators
University of Nottingham
Investigators
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Principal Investigator: Marina Coletta, Fellow in Gastroenterology Visiting fellow in Gastroenterology
Principal Investigator: Luca Marciani, Lecturer Lecturer in Gastrointestinal Imaging
Study Director: Robin Spiller, Professor Professor of Gastroenterology
Principal Investigator: Giles Major, Fellow University of Nottingham
Principal Investigator: Gemma Chaddock, BSc University of Nottingham

Publications:

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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT02104115    
Other Study ID Numbers: E12122013 SoM NDDC EEG
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: October 6, 2015
Last Verified: October 2015
Keywords provided by University of Nottingham:
Stomach
Small bowel
Colon
MRI
Function
Gastrointestinal volumes