Impact of Whole Grain Rye Bread on Health

NCT ID: NCT06333717

Last Updated: 2024-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-03
• Study Completion Date: 2021-11-05

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).

Conditions

Healthy Diet

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

High-fibre bread

Six slices (180 g) of whole grain rye bread divided over the meals during the day for 3 weeks

Group Type: EXPERIMENTAL

Whole grain bread

Intervention Type: DIETARY_SUPPLEMENT

Consumption of high-fibre bread as a dietary supplementation

Control bread

Six slices (180 g) of control bread containing refined wheat and oat flour divided over the meals during the day for 3 weeks

Group Type: PLACEBO_COMPARATOR

Control bread

Intervention Type: DIETARY_SUPPLEMENT

Consumption of control bread as a dietary supplementation

Interventions

Whole grain bread

Consumption of high-fibre bread as a dietary supplementation

Intervention Type: DIETARY_SUPPLEMENT

Control bread

Consumption of control bread as a dietary supplementation

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Örebro University, Sweden

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rebecca Wall, PhD

Role: PRINCIPAL_INVESTIGATOR

Örebro University, Sweden

Locations

Örebro University

Örebro, , Sweden

Countries

Sweden

Other Identifiers

Dnr 2020-03709

Identifier Type: -

Identifier Source: org_study_id