Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06333717
Status:
COMPLETED
Last Update Posted:
2024-03-27
First Post:
2024-02-28
Brief Title:
Impact of Whole Grain Rye Bread on Health
Sponsor:
Örebro University Sweden
Organization:
Örebro University Sweden
Study Overview
Official Title:
Impact of Whole Grain Rye Bread on Modulating Microbiota-gut-brain Axis in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2024-03
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:
FBS
Brief Summary:
This randomized controlled trial aims to study how a high intake of a fibre-rich bread affects the composition and functioning of the gut microbiota in healthy subjects and how this in turn impacts on the release of gut peptides intestinal permeability stress and cognitive performance
Detailed Description:
Healthy subjects will be recruited for a 3-week randomized parallel-controlled study Subjects that are eligible to take part in the study will be blinded and randomly allocated to consume a fibre-rich bread or a control bread daily for 3 weeks Measurements of biomarkers related to the gut-brain axis microbiota composition and functioning intestinal permeability stress and cognitive functioning will be conducted on two separate test days at baseline and after the 3 weeks intervention On both test days day 0 and day 21 subjects will come to the study centre after a 10 hours overnight fast and will deliver faecal samples collected at home At the study centre blood samples will be collected and a device for continuous assessment of autonomic nervous system response Biopac will be placed Subjects will drink a multisugar solution and urine samples will be collected for gut permeability analysis Sugar solution intake will be followed by a baseline period during which participants will rest for 30 minutes to adapt to the laboratory setting After the baseline period subjects will conduct a stress test and cognitive tests Visual analogue scales VAS to assess momentary perceived stress levels and saliva samples will be collected before and after the stress test The study subjects will also complete questionnaires at both visits food frequency questionnaire food diary physical activity gastrointestinal symptom rating scale Euro Quality of Life
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