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A Study of the Effect of Bran, Psyllium and Nopal on Intestinal Water Content Using Magnetic Resonance Imaging (NOPAL)

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ClinicalTrials.gov Identifier: NCT03263065
Recruitment Status : Recruiting
First Posted : August 28, 2017
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
University of Nottingham

Brief Summary:
This study will compare 3 food products (bran, psyllium and nopal) on intestinal water content measured via MRI.

Condition or disease Intervention/treatment Phase
Constipation Diet Modification Dietary Supplement: Bran Dietary Supplement: Nopal Dietary Supplement: Psyllium Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This will be a three-period, three-treatment crossover trial with blinding of data analysis
Masking: Single (Outcomes Assessor)
Masking Description: Data analysis will be blinded
Primary Purpose: Basic Science
Official Title: A Pilot Participant-blind Study of the Effect of Bran, Psyllium and Nopal on Intestinal Water Content Using Magnetic Resonance Imaging
Actual Study Start Date : April 18, 2018
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nopal added to test meal
test meal including nopal powder
Dietary Supplement: Nopal
220g rice pudding meal with raspberry jam with added nopal flakes

Experimental: Psyllium added to test meal
test meal including psyllium powder
Dietary Supplement: Psyllium
220g rice pudding meal with raspberry jam with added psyllium flakes

Experimental: Bran added to test meal
test meal including bran powder
Dietary Supplement: Bran
220g rice pudding meal with raspberry jam with added bran flakes




Primary Outcome Measures :
  1. Change from the baseline in T1 relaxation time (ms) of the chyme in the ascending colon [ Time Frame: baseline, immediately post ingestion, 1, 2, 3 and 4 hours post ingestion ]
    measured by MRI


Secondary Outcome Measures :
  1. Change from the baseline in small bowel water content (mL) [ Time Frame: baseline, immediately post ingestion, 1, 2, 3 and 4 hours post ingestion ]
    measured by MRI

  2. Change from the baseline in colonic volume in mL [ Time Frame: baseline, immediately post ingestion, 1, 2, 3 and 4 hours post ingestion ]
    measured by MRI

  3. Change from the baseline of breath hydrogen and methane (ppm) [ Time Frame: baseline, immediately post ingestion, 1, 2, 3 and 4 hours post ingestion ]
    measured using GastroCHeck



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 18 or older
  • Able to give informed consent

Exclusion Criteria:

  • 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

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): NCT03263065


Contacts
Contact: David Gunn, BMBS 01157484098 ext 84187 dgunn@nhs.net

Locations
United Kingdom
University of Nottingham Recruiting
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Contact: David Gunn, BMBS       david.gunn@nottingham.ac.uk   
Sponsors and Collaborators
University of Nottingham
Investigators
Study Chair: Robin Spiller, PhD University of Nottingham

Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT03263065     History of Changes
Other Study ID Numbers: NOPAL
First Posted: August 28, 2017    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by University of Nottingham:
Nopal
Bran
Psyllium

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Psyllium
Calcium polycarbophil
Cathartics
Gastrointestinal Agents
Antidiarrheals