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Completed

NCT Number: NCT02104115

Effects of Bread Gluten Content on Gastrointestinal Volumes

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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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nottingham Digestive Diseases Centre, E floor West Block, QMC Campus, Nottingham University Hospitals, Nottingham, United Kingdom

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI scanners

Other

VAS Symptom scores

Other

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Registry information

Acronym: EGG

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 4, 2014
Registry last updated
Oct 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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