Effect of Rate Of Delivery on Colonic Fermentation of inuliN (EON)

NCT05619341 | Completed

• 1 other identifier: FMHS 17-0622
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

To test whether slowing the rate of delivery of inulin with either psyllium or divided dosing of inulin, will reduce colonic gas production as compared to inulin combined with placebo. To obtain pilot data on link between habitual diet and fermentation of inulin.

Conditions

Irritable Bowel

Keywords

fermentation; gas; colonic; inulin; psyllium

Outcome Measures

Primary Outcomes (1)

• Hydrogen production

  AUC 0-24h

  2 days

Secondary Outcomes (2)

• Methane production

  2 days

• Intake of FOOMDAPS

  4 days

Study Arms (3)

inulin

PLACEBO COMPARATOR

20g inulin in 500ml water

Dietary Supplement: inulin

inulin + psyllium

ACTIVE COMPARATOR

Inulin 20g + 20g psyllium in 500 ml water

Dietary Supplement: psyllium; Dietary Supplement: inulin

inulin divided doses

ACTIVE COMPARATOR

2.5 g inulin in 62.5ml water given at 45 minute intervals

Dietary Supplement: inulin

Interventions

psyllium DIETARY_SUPPLEMENT

psyllium 20g

inulin + psyllium

inulin DIETARY_SUPPLEMENT

long chain fructan

inulin; inulin + psyllium; inulin divided doses

Eligibility Criteria

• Age: 18 Years - 70 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 ≤3 (i.e., mild, or less) for symptoms of flatulence, bloating and abdominal pain 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 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 potentially compromising participation in the study e.g., type 1 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 nor consume the standard meals required during the study day.
• Participants who are taking antibiotics or probiotics as they might alter 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

Study Sites (1)

Nottingham Digestive Disease Centre

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

Related Publications (4)

• Galvin MA, Kiely M, Harrington KE, Robson PJ, Moore R, Flynn A. The North/South Ireland Food Consumption Survey: the dietary fibre intake of Irish adults. Public Health Nutr. 2001 Oct;4(5A):1061-8. doi: 10.1079/phn2001187.

  PMID: 11820919 RESULT

• Dionne J, Ford AC, Yuan Y, Chey WD, Lacy BE, Saito YA, Quigley EMM, Moayyedi P. A Systematic Review and Meta-Analysis Evaluating the Efficacy of a Gluten-Free Diet and a Low FODMAPs Diet in Treating Symptoms of Irritable Bowel Syndrome. Am J Gastroenterol. 2018 Sep;113(9):1290-1300. doi: 10.1038/s41395-018-0195-4. Epub 2018 Jul 26.

  PMID: 30046155 RESULT

• 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 RESULT

• Alhasani AT, Modasia AA, Anodiyil M, Corsetti M, Aliyu AI, Crooks C, Marciani L, Reid J, Yakubov GE, Taylor M, Avery A, Harris H, Warren FJ, Spiller RC. Mode of Action of Psyllium in Reducing Gas Production from Inulin and its Interaction with Colonic Microbiota: A 24-hour, Randomized, Placebo-Controlled Trial in Healthy Human Volunteers. J Nutr. 2025 Mar;155(3):839-848. doi: 10.1016/j.tjnut.2024.12.017. Epub 2024 Dec 26.

  PMID: 39732438 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome; Mucopolysaccharidosis IV

Interventions

Psyllium; Inulin

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Mucopolysaccharidoses; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lysosomal Storage Diseases; Mucinoses; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: psyllium / maltodextrin added to 500ml water + inulin 20g
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Gastroenterology

Model Details: 3 way cross-over

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 16, 2022
• Study Start: October 28, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)