Impact of Whole Grain Rye Bread on Health

NCT06333717 | Completed

• 1 other identifier: Dnr 2020-03709
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Diet

Keywords

dietary fibre; microbiota; gut-brain axis

Outcome Measures

Primary Outcomes (1)

• Microbiota composition baseline vs after intervention using 16S RNA gene sequencing

  Difference in gut microbiota composition in faecal samples before (baseline) and after intake of six slices of bread for 3 weeks (after intervention) using 16S RNA gene sequencing

  faecal samples collected before and after intake of bread for 3 weeks

Secondary Outcomes (16)

• Microbiota composition whole grain rye bread vs control bread using 16S RNA gene sequencing

  faecal samples collected before and after intake of bread for 3 weeks

• Concentrations of circulatory short-chain fatty acids SCFA

  blood samples collected before and after intake of bread for 3 weeks

• Concentrations of faecal SCFA

  faecal samples collected before and after intake of bread for 3 weeks

• Concentrations of blood glucagon like peptide-1 (GLP-1)

  blood samples collected before and after intake of bread for 3 weeks

• Concentrations of blood glucagon like peptide-2 (GLP-2)

  blood samples collected before and after intake of bread for 3 weeks

Other Outcomes (10)

• Gastrointestinal symptoms measured by Gastrointestinal Symptom Rating Scale in Irritable Bowel Syndrome (GSRS-IBS)

  3 weeks

• Food habits measured by an electronic food frequency questionnaire Mealq

  3 weeks

• Food habits measured by a Food diary

  3 days

Study Arms (2)

High-fibre bread

EXPERIMENTAL

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

Dietary Supplement: Whole grain bread

Control bread

PLACEBO COMPARATOR

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

Dietary Supplement: Control bread

Interventions

Whole grain bread DIETARY_SUPPLEMENT

Consumption of high-fibre bread as a dietary supplementation

High-fibre bread

Control bread DIETARY_SUPPLEMENT

Consumption of control bread as a dietary supplementation

Control bread

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Örebro University, Sweden: lead

Study Sites (1)

Örebro University

Örebro, Sweden

Location

Study Officials

• Rebecca Wall, PhD

  Örebro University, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blinding
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 27, 2024
• Study Start: March 3, 2021
• Primary Completion: March 3, 2021
• Study Completion: November 5, 2021
• Last Updated: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)