University Hospital Clinical Research Centre
Nottingham, Nottinghamshire, NG7 2UH, United Kingdom
NCT Number: NCT05911347
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Nottingham, Nottinghamshire, NG7 2UH, United Kingdom
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:
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
15g psyllium added to inulin solution to form a gel
15 g methylcellulose added to inulin solution to form a gel
15g maltodextrin added to inulin solution to form a gel
Time frame: 0-6 hoursafter ingestion
AUC 0-6 hours after ingestion
Time frame: 0-24 hours post ingestion
AUC 0-24 hours
Time frame: 0-24 hours post ingestion
AUC 0-24 hours
Time frame: Whole gut transit measured once before intervention
whole gut transit time
University of Nottingham
Other
Effect of Modified Cellulose on Colonic Fermentation of Inulin (COCOA2)
Acronym: COCOA2
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