NCT06291272

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

Randomised Placebo Controlled Trial of Methylcellulose or Psyllium on Fermentation of inUlin Assessed USing MRI (RUFUS)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: University of Nottingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

Aim The aim is to test the hypothesis that a gel of either methylcellulose or psyllium incorporating inulin will reduce colonic gas volumes assessed by MRI 0-6 hours and 24 hours post ingestion as compared to inulin combined with placebo, maltodextrin. Objective The primary objective is to define the effect of methylcellulose and /or psyllium on colonic gas as assessed by MRI. Previous studies have used large doses to ensure a large effect to avoid a type II error however the doses used are well outside the normal consumption. The investigators wish to compare the effect of the methylcellulose mix on the fermentation of 15 g of inulin. Secondary Objectives A) Assess the effect of methylcellulose on gastric emptying, oro-cecal transit time (OCTT) by MRI assessment of arrival of "head of meal", regional MRI colonic appearances, including signal intensity at 6 and 24 hours to determine the likely length of effect, C) to asses breath hydrogen production over 24 hour post ingestion including overnight assessments, D) to assess Whole Gut Transit Time (WGTT) using blue muffins test, E) to measure AUC (0-24) for breath methane; F) to measure gas production over 48 hours incubation in vitro model of colon (in collaboration with Quadram Institute); G) to measure metabolite production (short chain fatty acids) using in vitro model of colon(in collaboration with Quadram Institute); H) to analyse microbiota using 16sRNA gene (in collaboration with Quadram Institute); I) to assess the effect of habitual dietary FODMAPs intake on breath hydrogen response to inulin.

Conditions

• Colon, Irritable

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Psyllium	15 g psyllium + 15 g inulin
DIETARY_SUPPLEMENT	Methylcellulose	15 g methylcellulose + 15 g inulin
DIETARY_SUPPLEMENT	Inulin	15 inulin
DIETARY_SUPPLEMENT	Maltodextrin	15 maltodextrin

Timeline

• Start date: 2023-10-15
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2024-03-04
• Last updated: 2024-08-12

Locations

1 site across 1 country: United Kingdom