Status:
COMPLETED
A Study of the Effect of Bran, Psyllium and Nopal on Intestinal Water Content Using Magnetic Resonance Imaging
Lead Sponsor:
University of Nottingham
Conditions:
Constipation
Diet Modification
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will compare 3 food products (bran, psyllium and nopal) on intestinal water content measured via MRI.
Detailed Description
BACKGROUND AND RATIONALE The role of dietary fibre in human health is a topic of both debate and research. Interpreting evidence is complicated by changes in the definition of fibre. In the UK the Sc...
Eligibility Criteria
Inclusion
- Aged 18 or older
- Able to give informed consent
Exclusion
- Pregnancy declared by candidate
- History declared by the candidate of pre-existing gastrointestinal disorder that may affect bowel function
- A positive diagnosis of irritable bowel syndrome based on the Rome IV criteria questionnaire
- Reported history of previous resection of the oesophagus, stomach or intestine (excluding appendix)
- Intestinal stoma
- Any medical condition making participation potentially compromising participation in the study e.g. diabetes mellitus, respiratory disease limiting ability to lie in the scanner, known allergy to one of the food products
- Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury
- Will not agree to dietary restrictions required in 24 hours before each MRI study day
- Unable to stop drugs known to alter GI motility including mebeverine, opiates, monoamine oxidase inhibitors, phenothiazines, benzodiazepines, calcium channel antagonists for the duration of the study (Selective serotonin reuptake inhibitors and low dose tricyclic antidepressants will be recorded but will not be an exclusion criteria)
- 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 6.00 AM
- 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
Key Trial Info
Start Date :
April 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2018
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03263065
Start Date
April 18 2018
End Date
November 1 2018
Last Update
April 17 2019
Active Locations (1)
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1
University of Nottingham
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH