Effect of Modified Cellulose on Colonic Fermentation of Inulin

NCT05911347 | Completed

• 1 other identifier: FMHS 19-0622
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

A 3-way randomised cross-over study to test the hypothesis that combining either psyllium or methylcellulose to form a gel incorporating inulin will reduce gas production as compared to inulin given with a placebo, maltodextrin. Subjects will attend on 3 separate days separated by a minimum of one week an consume one of 3 test meals. Serial breath samples with be obtained to measure hydrogen and methane over the next 24 hours. Primary endpoint: Area under curve (AUC) from time 0-6 hours (AUC 0-6) of breath hydrogen (ppm.hour) after treatment intake. The investigators will also assess whole gut transit time using the blue muffin and correlate breath hydrogen production with in vitro fermentation results.

Conditions

Irritable Bowel Syndrome

Keywords

FODMAP; Inulin; Psyllium; Cellulose

Outcome Measures

Primary Outcomes (1)

• Breath hydrogen

  AUC 0-6 hours after ingestion

  0-6 hoursafter ingestion

Secondary Outcomes (3)

• Breath hydrogen

  0-24 hours post ingestion

• Breath methane

  0-24 hours post ingestion

• Transit time

  Whole gut transit measured once before intervention

Study Arms (3)

Psyllium

ACTIVE COMPARATOR

Psyllium 15 g+ inulin 15 gm in 375ml water

Dietary Supplement: Psyllium

maltodextrin

PLACEBO COMPARATOR

Maltodextrin 15 g + inulin 15 gm in 375 ml water

Dietary Supplement: Maltodextrin

Methylcellulose

EXPERIMENTAL

Methylcellulose 15g + Inulin 15 g in 375 ml water

Dietary Supplement: Methylcellulose

Interventions

Psyllium DIETARY_SUPPLEMENT

15g psyllium added to inulin solution to form a gel

Psyllium

Methylcellulose DIETARY_SUPPLEMENT

15 g methylcellulose added to inulin solution to form a gel

Methylcellulose

Maltodextrin DIETARY_SUPPLEMENT

15g maltodextrin added to inulin solution to form a gel

maltodextrin

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.
• 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 sampling period.

You may not qualify if:

• Pregnancy 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.
• 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.
• Will not agree to dietary 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
• University of East Anglia: collaborator

Study Sites (1)

University Hospital Clinical Research Centre

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

Related Publications (2)

• Gunn D, Abbas Z, Harris HC, Major G, Hoad C, Gowland P, Marciani L, Gill SK, Warren FJ, Rossi M, Remes-Troche JM, Whelan K, Spiller RC. Psyllium reduces inulin-induced colonic gas production in IBS: MRI and in vitro fermentation studies. Gut. 2022 May;71(5):919-927. doi: 10.1136/gutjnl-2021-324784. Epub 2021 Aug 5.

  PMID: 34353864 BACKGROUND

• Reid JESJ, Alhasani AT, MacCalman T, Amor D, Aliyu AI, Modasia AA, Harris H, Warren FJ, Hoad C, Gowland PA, Yakubov GE, Crooks C, Corsetti M, Marciani L, Spiller RC. A randomised, placebo-controlled trial in healthy humans of modified cellulose or psyllium evaluating the role of gelation in altering colonic gas production during inulin co-administration. Food Funct. 2026 Feb 4. doi: 10.1039/d5fo03532e. Online ahead of print.

  PMID: 41636227 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Psyllium; Methylcellulose; 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

Study Officials

• Robin D Spiller, MD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Test meals will have similar appearance and flavour
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3 way cross-over

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: June 22, 2023
• Study Start: May 9, 2023
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: August 15, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)