NCT05911347

Effect of Modified Cellulose on Colonic Fermentation of Inulin

Effect of Modified Cellulose on Colonic Fermentation of Inulin (COCOA2)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Nottingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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. Whole gut transit time will be assessed from the time that stool turns blue after ingestion of a muffin labelled with blue food colouring. Secondary endpoint: 1. AUC (0-24h) breath hydrogen / methane 2. Oro-cecal transit time and whole gut transit time. 3. Gas production/ metabolites/ microbiota during in vitro fermentation studies at Quadram 4. Effect of habitual dietary FODMAPs intake on breath hydrogen response to inulin. The interventions will be dietary interventions, using all food grade materials (sugars and fibres) provided in commonly used doses: Breath hydrogen will be correlated with in vitro carbohydrate fermentation profile assessed using stool samples collected before intervention

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Psyllium	15g psyllium added to inulin solution to form a gel
DIETARY_SUPPLEMENT	Methylcellulose	15 g methylcellulose added to inulin solution to form a gel
DIETARY_SUPPLEMENT	Maltodextrin	15g maltodextrin added to inulin solution to form a gel

Timeline

• Start date: 2023-05-09
• Primary completion: 2023-08-31
• Completion: 2023-08-31
• First posted: 2023-06-22
• Last updated: 2024-08-15

Locations

1 site across 1 country: United Kingdom