Ignite Creation Date:
2024-10-25 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06551961
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
A Randomised Placebo Controlled Trial of Chronic Feeding of INuliN And Methylcellulose On Colonic fermentatioN
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomised Placebo Controlled Trial of Chronic Feeding of INuliN And Methylcellulose On Colonic fermentatioN
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CINNAMON
Brief Summary:
To determine the effect on tolerance and gas production from chronic feeding of fermentable fibre inulin incorporated into a gel forming fibre methylcellulose compared with placebo maltodextrin
Detailed Description:
Our 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 Our previous studies have shown how psyllium a gel forming natural fibre can reduce gas production induced by a dietary FODMAP inulin when it reaches the colon We are 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
We have completed a study using a modified methylcellulose which was shown to be non-inferior to psyllium
Our previous studies point to the importance of habitual FODMAP intake which is likely to alter the microbiota selecting those that can efficiently utilise fructans We want to understand whether chronic feeding of inulin along with methylcellulose a gel-forming dietary fibre which persists in the colon will significantly alter the tolerance to inulin relative to chronic feeding of inulin with a suitable placebo maltodextrin Maltodextrin is rapidly absorbed in the small bowel and therefore has no effect on colonic fermentation We plan to run a chronic feeding study in IBS patients and wish to ascertain tolerability of repeated use as previous studies have only provided single doses
With this in mind we plan to provide inulin and methylcellulose for daily consumption by healthy adults for a period of two weeks The intervention will be divided into 3 portions to be taken before breakfast lunch and supper In week 1 the portions will contain 25 g of both inulin and methylcellulose in 625 mL water In week 2 the portions will contain 50 g of both inulin and methylcellulose in 125 mL water The participants will also follow the same chronic feeding schedule but with a maltodextrin placebo as opposed to methylcellulose with randomisation of study schedule taking place at screening
We will use MRI at baseline and at 2 weeks to assess changes in colonic volume and transit utilising high MRI contrast capsules54 We will collect stool samples at baseline and after 1 and 2 weeks of chronic feeding for each study intervention to monitor the expected changes in microbiota The primary objective is to assess the fermentation of inulin given as a single 15g with or without methylcellulose from the breath hydrogen response at baseline and after the 2 weeks feeding
We have completed a study using a modified methylcellulose which was shown to be non-inferior to psyllium
Our previous studies point to the importance of habitual FODMAP intake which is likely to alter the microbiota selecting those that can efficiently utilise fructans We want to understand whether chronic feeding of inulin along with methylcellulose a gel-forming dietary fibre which persists in the colon will significantly alter the tolerance to inulin relative to chronic feeding of inulin with a suitable placebo maltodextrin Maltodextrin is rapidly absorbed in the small bowel and therefore has no effect on colonic fermentation We plan to run a chronic feeding study in IBS patients and wish to ascertain tolerability of repeated use as previous studies have only provided single doses
With this in mind we plan to provide inulin and methylcellulose for daily consumption by healthy adults for a period of two weeks The intervention will be divided into 3 portions to be taken before breakfast lunch and supper In week 1 the portions will contain 25 g of both inulin and methylcellulose in 625 mL water In week 2 the portions will contain 50 g of both inulin and methylcellulose in 125 mL water The participants will also follow the same chronic feeding schedule but with a maltodextrin placebo as opposed to methylcellulose with randomisation of study schedule taking place at screening
We will use MRI at baseline and at 2 weeks to assess changes in colonic volume and transit utilising high MRI contrast capsules54 We will collect stool samples at baseline and after 1 and 2 weeks of chronic feeding for each study intervention to monitor the expected changes in microbiota The primary objective is to assess the fermentation of inulin given as a single 15g with or without methylcellulose from the breath hydrogen response at baseline and after the 2 weeks feeding
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None