Effect of Methylcellulose or Psyllium on Fermentation of inUlin Assessed USing MRI

NCT06291272 | Completed

• 1 other identifier: FMHS 328-0723
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The challenge is to understand how fibre interacts with whole-gut function to alter colonic fermentation of fermentable oligo-di- and mono-saccharides and polyhydric alcohols (FODMAPs). Studies will exploit the recent availability of a range of food grade modified celluloses which can form gels at body temperature to perform human studies to explore whether the beneficial effect of psyllium is unique or will be found with all gelling substances (4). The investigators are currently performing the COCOA2 study (Effect of modified cellulose on colonic fermentation of inulin) using a modified methylcellulose (results awaited). The investigators now wish to image what happens in the colon when methylcellulose is ingested to enable planning of the next step in the research programme.

Conditions

Colon, Irritable

Outcome Measures

Primary Outcomes (1)

• colonic gas volume

  AUC 0-6 hours of colonic gas volume

  0-6 hours

Secondary Outcomes (4)

• colonic gas volume at 6 hours

  0-6 hours

• Breath hydrogen

  0-6 hours

• Oro-cecal transit time

  0- 6 hours

• 24 hour breath hydrogen

  0-24 hours

Study Arms (3)

Psyllium

EXPERIMENTAL

375 ml containing 15g inulin made up in 375 ml water with 15 g psyllium husk

Dietary Supplement: Psyllium; Dietary Supplement: Inulin

Methylcelulose

EXPERIMENTAL

375 ml containing 15g inulin made up in 375 ml water with 15g modified methylcellulose

Dietary Supplement: Methylcellulose; Dietary Supplement: Inulin

Maltodextrin

PLACEBO COMPARATOR

375 ml containing 15g inulin made up in 375 ml water with maltodextrin powder (placebo)

Dietary Supplement: Inulin; Dietary Supplement: Maltodextrin

Interventions

Psyllium DIETARY_SUPPLEMENT

15 g psyllium + 15 g inulin

Psyllium

Methylcellulose DIETARY_SUPPLEMENT

15 g methylcellulose + 15 g inulin

Methylcelulose

Inulin DIETARY_SUPPLEMENT

15 inulin

Maltodextrin; Methylcelulose; Psyllium

Maltodextrin DIETARY_SUPPLEMENT

15 maltodextrin

Maltodextrin

Eligibility Criteria

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

You may qualify if:

• Able to give informed consent.
• Scoring ≤5 (i.e., mild, or less) for symptoms of flatulence, bloating, abdominal pain, loose stool, and hard stool in previous 2 weeks using a modified Gastrointestinal Symptom Rating Scale (5).
• Agrees to consume the meals provided.
• Agrees to not smoke during the breath hydrogen sampling period.

You may not qualify if:

• Pregnancy, lactating, or planning pregnancy during the course of the investigation declared by candidate.
• History declared by the candidate of pre-existing gastrointestinal disorder that may affect bowel function.
• Reported history of previous resection of the oesophagus, stomach, or intestine (excluding appendix).
• Intestinal stoma.
• Have contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury.
• Unable to lie flat and relatively still for less than 5 minutes.
• Any medical condition making participation potentially compromising participation in the study e.g., diabetes mellitus, respiratory disease limiting ability to use breath hydrogen analyser, known intolerance to one of the test substances.
• Has a body mass index (BMI) value less than 18.5 or greater than 35.
• Will not agree to follow dietary and lifestyle restrictions required.
• Participants who are taking antibiotics or probiotics as it might alters gut microbiota.
• 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.
• 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.
• Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance.

Sponsors & Collaborators

• University of Nottingham: lead
• Quadram Institute Bioscience: collaborator

Study Sites (1)

Nottingham Digestive Disease Centre

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Psyllium; Methylcellulose; Inulin; maltodextrin

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures; Cellulose; Glucans; Polysaccharides; Carbohydrates; Starch; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Fructans

Study Officials

• Robin Spiller, MD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Opaque plastic bags containing test meals prepared by some one not involved in analysis pf results
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3 way cross -over

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 4, 2024
• Study Start: October 15, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)