NCT06494137

Effect of Pre-dosing With Methylcellulose or Psyllium on Colonic Fermentation of Inulin

Effect of Pre-dosing With Methylcellulose or Psyllium on Colonic Fermentation of Inulin (COCOA3)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: University of Nottingham · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The aim for this pilot study is to test the hypothesis that pre-dosing with gel-forming dietary fibres (methylcellulose or psyllium) will alter the colonic fermentation of a model fermentable dietary fibre (Inulin) when delivered separately, in contrast to our previous trials where gel-forming and fermentable dietary fibres were co-administered. Performance of each gel-forming dietary fibre will be compared to placebo (water) to assess treatment effectiveness.

Detailed description

4\. BACKGROUND AND RATIONALE The challenge is to understand how various dietary fibres interact to alter colonic fermentation of FODMAPs (fermentable oligosaccharides, disaccharides, monosaccharides and polyols) with the aim of reducing gaseous distension of the colon and hence symptoms. Previous studies 1 have shown how psyllium, a gel forming natural fibre can reduce gas production induced by a dietary FODMAP inulin when it reaches the colon. The investigation will exploiting 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 2. The mode of action of methylcellulose and psyllium on the reduction in gas production from inulin remains unclear. Possible mechanisms include 1) slowing delivery to the colon by their effect in the small bowel, 2) delayed release of inulin from the dietary fibre gel matrix (i.e. a physical effect) in the colon 3) or a direct effect on the colonic bacteria reducing their production of gas (i.e. a microbiological effect). References Aim This pilot study will test the hypothesis that pre-dosing with gel-forming dietary fibres (methylcellulose or psyllium) will alter the colonic fermentation of a model fermentable dietary fibre (Inulin) when delivered separately, in contrast to our previous trials where gel-forming and fermentable dietary fibres were co-administered. Performance of each gel-forming dietary fibre will be compared to placebo (water) to assess treatment effectiveness. Objective The primary objective of this pilot is to compare the effect of pre-feeding a gel-forming dietary fibre (methylcellulose or psyllium) compared to placebo (water) on the colonic fermentability of Inulin over the six hours immediately post inulin ingestion as assessed from breath hydrogen production. Secondary Objectives 1. Area under curve (AUC) of breath hydrogen and methane for period 0 - 24hr. 2. Orocecal transit time (OCTT) from breath analysis. 3. Whole gut transit time assessed by blue muffin test. 4. Gas production with in vitro model of colon using participants stool samples (Quadram Institute). 5. Metabolite production (short chain fatty acids) using same in vitro model of colon (Quadram Institute). 6. Analysis of microbiota in participants stool using 16sRNA gene (in collaboration with Quadram Institute). 7. Assessment of habitual dietary FODMAP intake on breath hydrogen response to Inulin

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
OTHER	inulin	inulin from chicory root

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2024-07-10
• Last updated: 2024-07-30

Locations

1 site across 1 country: United Kingdom