Ignite Creation Date:
2024-07-17 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06494137
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-07-02
Brief Title:
Effect of Pre-dosing With Methylcellulose or Psyllium on Colonic Fermentation of Inulin
Sponsor:
University of Nottingham
Organization:
University of Nottingham
Study Overview
Official Title:
Effect of Pre-dosing With Methylcellulose or Psyllium on Colonic Fermentation of Inulin COCOA3
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COCOA3
Brief 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 ie a physical effect in the colon 3 or a direct effect on the colonic bacteria reducing their production of gas ie 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
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 ie a physical effect in the colon 3 or a direct effect on the colonic bacteria reducing their production of gas ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None