Impact of Whole Grain Rye Bread on Health (FBS)

Örebro University, Sweden

Status

Completed

Conditions

Healthy Diet

Treatments

Dietary Supplement: Control bread

Dietary Supplement: Whole grain bread

Study type

Interventional

Funder types

Other

Identifiers

NCT06333717

Dnr 2020-03709

Details and patient eligibility

About

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.

Full 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).

Enrollment

33 patients

Sex

All

Ages

18 to 44 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age 18-44 years
Body mass index (BMI) 18,5-30 kg/m2 (normal weight or overweight)

Exclusion criteria

Significant acute or chronic illness, including an inflammatory or a functional disease of gastrointestinal track and psychiatric and psychological disorders
Anxiety or depression (according to Hospital Anxiety and Depression Scale (HADS score) and Depression Anxiety Stress Scale (DASS-21 score))
Use of a medication that may interfere with the study (e.g. cannabis, antipsychotics, anxiolytics, antidepressants, proton-pump inhibitors)
Abuse of alcohol or drugs (according to AUDIT score)
Use of antibiotic medication within the past 3 months before the study
Use of laxative or anti-diarrhoea medication within the past 3 months before the study
Regular consumption of probiotic or prebiotic product for the past 6 weeks before the study
A diet that may interfere with the study (such as gluten free or low-carb diet)
Smoking
Pregnancy or breastfeeding
Premenopausal female with irregular or short menstruation cycle and not using hormonal contraception
Colour blindness, dyslexia or dyscalculia
Unable to absent from caffeine, alcohol or intense exercise for 12 hours prior measurements.