NCT06333717

Impact of Whole Grain Rye Bread on Health

Impact of Whole Grain Rye Bread on Modulating Microbiota-gut-brain Axis in Healthy Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Örebro University, Sweden · Academic / Other
• Sex: All
• Age: 18 Years – 44 Years
• Healthy volunteers: Accepted

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).

Conditions

• Healthy Diet

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Whole grain bread	Consumption of high-fibre bread as a dietary supplementation
DIETARY_SUPPLEMENT	Control bread	Consumption of control bread as a dietary supplementation

Timeline

• Start date: 2021-03-03
• Primary completion: 2021-03-03
• Completion: 2021-11-05
• First posted: 2024-03-27
• Last updated: 2024-03-27

Locations

1 site across 1 country: Sweden