Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06528041
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Impact of Native Chicory Inulin on Change and Persistence of Gut Microbiota
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Native Chicory Inulin Supplementation on Rates of Microbial Change Between Individuals
Status:
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:
None
Brief Summary:
The main aim of this study is to investigate differences in rate extent of change and persistence of the gut microbiota in healthy adult volunteers in response to native chicory inulin Along with investigating the impact of native chicory on bowl habits mood and appetite The two main questions this study aims to answer
To what extent do differences exist in rate of change over time between individuals in gut microbiota response Bifidobacterium growth to native chicory inulin supplementation
To what extent do differences exist between individuals in persistence of the gut microbiota upon stopping supplementation
The effects of native chicory inulin on gut microbiota response will be compared to a maltodextrin placebo to sure changes in gut microbiota result directly from chicory inulin supplementation
Participants will firstly complete a one-week run-in phase to establish baseline data and will then be allocated to either native chicory inulin or maltodextrin supplementation for 6 weeks Inulin will be delivered at 12 gday split into 2 x 6g portions Maltodextrin will be calorie matched at 6 gday split into 2 x 3g portions This will then be followed by a 6 week post-supplementation phase Fecal and blood samples will be collected regularly throughout all phases for analysis of gut microbiota and compounds of interest Participants will also record any changes in gastrointestinal sensation bowel habits and mood in a diary Changes in appetite sensation will also measured
To what extent do differences exist in rate of change over time between individuals in gut microbiota response Bifidobacterium growth to native chicory inulin supplementation
To what extent do differences exist between individuals in persistence of the gut microbiota upon stopping supplementation
The effects of native chicory inulin on gut microbiota response will be compared to a maltodextrin placebo to sure changes in gut microbiota result directly from chicory inulin supplementation
Participants will firstly complete a one-week run-in phase to establish baseline data and will then be allocated to either native chicory inulin or maltodextrin supplementation for 6 weeks Inulin will be delivered at 12 gday split into 2 x 6g portions Maltodextrin will be calorie matched at 6 gday split into 2 x 3g portions This will then be followed by a 6 week post-supplementation phase Fecal and blood samples will be collected regularly throughout all phases for analysis of gut microbiota and compounds of interest Participants will also record any changes in gastrointestinal sensation bowel habits and mood in a diary Changes in appetite sensation will also measured
Detailed Description:
The term prebiotic was established in 1995 and has since undergone several updates in definition As of 2017 the International Scientific Association for Probiotics and Prebiotics ISAPP defines prebiotics as a substrates that is selectivity utilised by the host microorganism conferring a health benefit Of all prebiotics the most highly researched prebiotics are inulin and fructo-oligosaccharides that belong to a group of non-digestible carbohydrates referred to as inulin-type fructans The main concept behind prebiotics is to stimulate selective changes in microbiota - namely Bifidobacterium in regards to inulin-type fructans The ability for inulin-type fructans to stimulate changes in bifidobacteria has been demonstrated across across a wide array of studies Yet while in vivo studies suggest that inulin-type fructans exert a bifidogenic effect substantial differences in changes in bifidobacteria responses are often documented between individuals More specifically evidence is lacking regarding differences in the rate extent of change and persistence of the gut microbiota upon the commencement and seizing of inulin supplementation While increasing pre-clinical data suggests that a wide variety of bacteria found within the gut can utilise inulin-type fructans in addition to just Bifidobacterium The aims of this research study are to explore effects that supplementation with 12 gday inulin-type fructans has on frequent changes in gut microbiota load composition gastrointestinal sensation flatulence intestinal bloating abdominal pain and abdominal pressure bowel habits stool frequency and stool consistency and mood with maltodextrin employed as a placebo control 6 gday This study will also examine differences in appetite sensation and blood metabolites The study will consist of 3 phases - a one-week run-in phase a 6-week supplementation phase and a 6-week post-supplementation phase
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