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

NCT03263065 | Completed

• 1 other identifier: NOPAL
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Constipation; Diet Modification

Keywords

Nopal; Bran; Psyllium

Outcome Measures

Primary Outcomes (1)

• Change from the baseline in T1 relaxation time (ms) of the chyme in the ascending colon

  measured by MRI

  baseline, immediately post ingestion, 1, 2, 3 and 4 hours post ingestion

Secondary Outcomes (3)

• Change from the baseline in small bowel water content (mL)

  baseline, immediately post ingestion, 1, 2, 3 and 4 hours post ingestion

• Change from the baseline in colonic volume in mL

  baseline, immediately post ingestion, 1, 2, 3 and 4 hours post ingestion

• Change from the baseline of breath hydrogen and methane (ppm)

  baseline, immediately post ingestion, 1, 2, 3 and 4 hours post ingestion

Study Arms (3)

Nopal added to test meal

EXPERIMENTAL

test meal including nopal powder

Dietary Supplement: Nopal

Psyllium added to test meal

EXPERIMENTAL

test meal including psyllium powder

Dietary Supplement: Psyllium

Bran added to test meal

EXPERIMENTAL

test meal including bran powder

Dietary Supplement: Bran

Interventions

Bran DIETARY_SUPPLEMENT

220g rice pudding meal with raspberry jam with added bran flakes

Bran added to test meal

Nopal DIETARY_SUPPLEMENT

220g rice pudding meal with raspberry jam with added nopal flakes

Nopal added to test meal

Psyllium DIETARY_SUPPLEMENT

220g rice pudding meal with raspberry jam with added psyllium flakes

Psyllium added to test meal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 or older
• Able to give informed consent

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

University of Nottingham

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

Related Publications (1)

• Gunn D, Murthy R, Major G, Wilkinson-Smith V, Hoad C, Marciani L, Remes-Troche J, Gill S, Rossi M, Harris H, Ahn-Jarvis J, Warren F, Whelan K, Spiller R. Contrasting effects of viscous and particulate fibers on colonic fermentation in vitro and in vivo, and their impact on intestinal water studied by MRI in a randomized trial. Am J Clin Nutr. 2020 Sep 1;112(3):595-602. doi: 10.1093/ajcn/nqaa173.

  PMID: 32619212 DERIVED

MeSH Terms

Conditions

Constipation

Interventions

Psyllium

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Robin Spiller, PhD

  University of Nottingham

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data analysis will be blinded
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a three-period, three-treatment crossover trial with blinding of data analysis

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: August 28, 2017
• Study Start: April 18, 2018
• Primary Completion: October 1, 2018
• Study Completion: November 1, 2018
• Last Updated: April 17, 2019

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)