Ignite Creation Date:
2024-05-06 @ 6:03 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05526092
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2022-08-26
Brief Title:
OAT-GUT-BRAIN Effects of Oats and Rice on Comprehensive Health of Metabolically Challenged Individuals
Sponsor:
University of Turku
Organization:
University of Turku
Study Overview
Official Title:
OAT-GUT-BRAIN Comprehensive Health Effects of Long-term Consumption of Oats in Metabolically Challenged Volunteers - Gut-mediated Metabolomics and Vitality
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
The overall objective of this research entity is to reveal the holistic health impact of oats in metabolically challenged individuals in a 6-week intervention compared to that of rice This is achieved by investigation of the plasma lipids plasma antioxidant status fecal microbiota and fecal bile acids Additionally the effect of the 6-week diet on posptprandial glycemia and postprandial satiety and vitality are investigated
Detailed Description:
Aims in this 6-week randomised single-blinded clinical trial including a postprandial study at the 6 week time point with metabolically challenged volunteers on oat-rich low-gluten diet are to
1 Compare effect of oat and rice rich diets to blood lipid and glucose status perceived gut well-being and diet quality
2 Investigate changes in microbiota SCFAs plasma antioxidant status and inflammation markers resulting from consumption of oat or rice rich low gluten diets
3 Examine the impact of the oat and rice rich gluten free diet on the change in metabolite profiles in blood
4 Find out the long-term effects of oat and rice consumption on recovery and vitality by modulating the gut-brain axis and measured with neuropsychological testing and using tryptophan metabolites as markers
5 Discover how the long-term consumption of oats and rice and their possible alterations in gut microbiota affect subsequent postprandial glycaemia and response of microbiota to the meal as seen in plasma SCFAs
1 Compare effect of oat and rice rich diets to blood lipid and glucose status perceived gut well-being and diet quality
2 Investigate changes in microbiota SCFAs plasma antioxidant status and inflammation markers resulting from consumption of oat or rice rich low gluten diets
3 Examine the impact of the oat and rice rich gluten free diet on the change in metabolite profiles in blood
4 Find out the long-term effects of oat and rice consumption on recovery and vitality by modulating the gut-brain axis and measured with neuropsychological testing and using tryptophan metabolites as markers
5 Discover how the long-term consumption of oats and rice and their possible alterations in gut microbiota affect subsequent postprandial glycaemia and response of microbiota to the meal as seen in plasma SCFAs
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