Ignite Creation Date:
2024-05-06 @ 7:12 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05931562
Status:
RECRUITING
Last Update Posted:
2023-07-05
First Post:
2023-06-12
Brief Title:
The Impact of Diet on the Gut-Microbiota-Brain Axis
Sponsor:
University College Cork
Organization:
University College Cork
Study Overview
Official Title:
An Interventional Study on the Association Between Diet Cognitive Function Stress and the Gut Microbiota in Healthy Volunteers
Status:
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:
NMB
Brief Summary:
This study aims to investigate the effects of an 8-week dietary intervention on cognitive function stress and the gut microbiota in healthy adults with low fibre intake
Detailed Description:
The gut microbiota communicates bidirectionally with the brain via the microbiota-gut-brain axis to influence various aspects of human physiology including host metabolism immune function behaviour and cognition Diet is a key modulator of the microbial composition suggesting that the microbiota could explain the association between poor nutrition and decreasing health of the population Dietary fibre is the main energy source for the gut microbiota and fundamentally impacts its composition and function The microbiota-gut-brain axis has been proposed to mediate some of the effects of dietary fibre on the brain for example through microbial metabolites eg short-chain fatty acids SCFA regulation of the immune system and the microbial impact on gut hormones and neurotransmitters Similarly intake of fermented foods is positively associated with cognitive health and has been shown to alter the microbiota composition and function and exert an anti-inflammatory effect However no studies to date have examined the singular and combined effects of fermented and fibrous foods on the gut microbiota cognition and emotion The present study aims to determine the role of diet on the microbiota-gut-brain axis and mental health
Using a randomized-controlled parallel single-blinded design participants consuming a habitually low fibre diet N200 will undergo an 8-week dietary intervention Participants will receive one of four diets n50 in each group high fibre aim 24-35 gramsday fermented foods aim 4-6 portionsday combined diet of fermented foods and high fibre aim 25-30gday of fibre and 3-4 servingsday of fermented foods or control dietary education according to national Irish guidelines Cognitive psychological and biological measures will be compared at baseline and endpoint During the intervention period individuals will provide repeated faecal samples to assess temporal microbial changes
Using a randomized-controlled parallel single-blinded design participants consuming a habitually low fibre diet N200 will undergo an 8-week dietary intervention Participants will receive one of four diets n50 in each group high fibre aim 24-35 gramsday fermented foods aim 4-6 portionsday combined diet of fermented foods and high fibre aim 25-30gday of fibre and 3-4 servingsday of fermented foods or control dietary education according to national Irish guidelines Cognitive psychological and biological measures will be compared at baseline and endpoint During the intervention period individuals will provide repeated faecal samples to assess temporal microbial changes
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