Impact of Whole Grain Rye Bread on Health (FBS)

March 20, 2024 updated by: Örebro University, Sweden

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Örebro, Sweden
        • Örebro university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: High-fibre bread
Six slices (180 g) of whole grain rye bread divided over the meals during the day for 3 weeks
Dietary supplement: Whole grain bread
Consumption of high-fibre bread as a dietary supplementation
Placebo Comparator: 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
Dietary supplement: Control bread
Consumption of control bread as a dietary supplementation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Microbiota composition baseline vs after intervention using 16S RNA gene sequencing
Time Frame: faecal samples collected before and after intake of bread for 3 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Microbiota composition whole grain rye bread vs control bread using 16S RNA gene sequencing
Time Frame: faecal samples collected before and after intake of bread for 3 weeks
Difference in gut microbiota composition in faecal samples between the study arms 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
Time Frame: blood samples collected before and after intake of bread for 3 weeks
Difference in blood levels of SCFA between and within intervention groups after intake of bread for 3 weeks
blood samples collected before and after intake of bread for 3 weeks
Concentrations of faecal SCFA
Time Frame: faecal samples collected before and after intake of bread for 3 weeks
Difference in faecal levels of SCFA between and within intervention groups after intake of bread for 3 weeks
faecal samples collected before and after intake of bread for 3 weeks
Concentrations of blood glucagon like peptide-1 (GLP-1)
Time Frame: blood samples collected before and after intake of bread for 3 weeks
Difference in blood levels of GLP-1 between and within intervention groups after intake of bread for 3 weeks
blood samples collected before and after intake of bread for 3 weeks
Concentrations of blood glucagon like peptide-2 (GLP-2)
Time Frame: blood samples collected before and after intake of bread for 3 weeks
Difference in blood levels of GLP-2 between and within intervention groups after intake of bread for 3 weeks
blood samples collected before and after intake of bread for 3 weeks
Concentrations of blood peptide YY (PYY)
Time Frame: blood samples collected before and after intake of bread for 3 weeks
Difference in blood levels of PYY between and within intervention groups after intake of bread for 3 weeks
blood samples collected before and after intake of bread for 3 weeks
Concentrations of blood gastric inhibitory polypeptide (GIP)
Time Frame: blood samples collected before and after intake of bread for 3 weeks
Difference in blood levels of GIP between and within intervention groups after intake of bread for 3 weeks
blood samples collected before and after intake of bread for 3 weeks
Concentrations of blood neuroactive peptide Y (NPY)
Time Frame: blood samples collected before and after intake of bread for 3 weeks
Difference in blood levels of NPY between and within intervention groups after intake of bread for 3 weeks
blood samples collected before and after intake of bread for 3 weeks
Concentrations of blood brain-derived neurotrophic factor (BDNF)
Time Frame: blood samples collected before and after intake of bread for 3 weeks
Difference in blood levels of BDNF between and within intervention groups after intake of bread for 3 weeks
blood samples collected before and after intake of bread for 3 weeks
Concentrations of blood cytokines
Time Frame: blood samples collected before and after intake of bread for 3 weeks
Difference in blood levels of cytokines between and within intervention groups after intake of bread for 3 weeks
blood samples collected before and after intake of bread for 3 weeks
Concentrations of blood alkylresorcinols
Time Frame: blood samples collected before and after intake of bread for 3 weeks
Difference in blood levels of alkylresorcinols between and within intervention groups after intake of bread for 3 weeks
blood samples collected before and after intake of bread for 3 weeks
Concentrations of blood lipopolysaccharide-binding protein (LBP)
Time Frame: blood samples collected before and after intake of bread for 3 weeks
Difference in blood levels of LBP between and within intervention groups after intake of bread for 3 weeks
blood samples collected before and after intake of bread for 3 weeks
Concentrations of blood soluble CD-14 (sCD-14)
Time Frame: blood samples collected before and after intake of bread for 3 weeks
Difference in blood levels of sCD-14 between and within intervention groups after intake of bread for 3 weeks
blood samples collected before and after intake of bread for 3 weeks
Concentrations of sugars in urine
Time Frame: urine samples collected before and after intake of bread for 3 weeks
Difference on intestinal permeability between and within intervention groups after intake of bread for 3 weeks measured by the excretion of sugars contained in a multi-sugar solution
urine samples collected before and after intake of bread for 3 weeks
Concentrations of saliva cortisol during stress test
Time Frame: Saliva samples collected before the stress test, after the introduction phase, directly after the acute stress phase, 5 minutes, 10-15 minutes, 60 minutes, and 75 minutes after the stress test
Difference in saliva levels of cortisol produced during stress test between and within intervention groups after intake of bread for 3 weeks
Saliva samples collected before the stress test, after the introduction phase, directly after the acute stress phase, 5 minutes, 10-15 minutes, 60 minutes, and 75 minutes after the stress test
Concentrations of saliva alpha-amylase during stress test
Time Frame: Saliva samples collected before the stress test, after the introduction phase, directly after the acute stress phase, 5 minutes, 10-15 minutes, 60 minutes, and 75 minutes after the stress test
Difference in saliva levels of a-amylase produced during stress test between and within intervention groups after intake of bread for 3 weeks
Saliva samples collected before the stress test, after the introduction phase, directly after the acute stress phase, 5 minutes, 10-15 minutes, 60 minutes, and 75 minutes after the stress test

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gastrointestinal symptoms measured by Gastrointestinal Symptom Rating Scale in Irritable Bowel Syndrome (GSRS-IBS)
Time Frame: 3 weeks
Difference in the frequency and severity of gastrointestinal symptoms between and within intervention groups after the intake of bread for 3 weeks. The GSRS-IBS contains 13 self-report items rated on a 6-point Likert scale ranging from 1 (no discomfort at all) to 7 (very severe discomfort). Total scores range from 0 to 78.
3 weeks
Food habits measured by an electronic food frequency questionnaire Mealq
Time Frame: 3 weeks
Survey of participants' food habits before and during the intake of bread for 3 weeks
3 weeks
Food habits measured by a Food diary
Time Frame: 3 days
Survey of participants' food habits before and during the intake of bread for 3 weeks
3 days
Physical activity measured by the International Physical Activity Questionnaire (IPAQ)
Time Frame: 3 days
Survey of participants' physical activities before and during the intake of bread for 3 weeks. The IPAQ contains 7 self-report questions and the categorical score is divided into 3 levels: low (less than 600 metabolic equivalent-minutes/week), moderate (at least 600 metabolic equivalent-minutes/week) or high (at least 1500 metabolic equivalent-minutes/week).
3 days
Quality of life measured by the Euro Quality of Life questionnaire
Time Frame: once before and after intake of bread for 3 weeks
Survey of participants' well-being before and during the intake of bread for 3 weeks. It records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled from 0 (worst imaginable health state) to 100 (best imaginable health state).
once before and after intake of bread for 3 weeks
Perceived stress measured by a Visual analog scale questionnaire
Time Frame: before the stress test, after the introduction phase, directly after the acute stress phase, 5 minutes, 10-15 minutes, 60 minutes, and 75 minutes after the stress test
Difference in the perceived stress during a stress test between and within intervention groups after the intake of bread for 3 weeks
before the stress test, after the introduction phase, directly after the acute stress phase, 5 minutes, 10-15 minutes, 60 minutes, and 75 minutes after the stress test
Cognitive control using Eriksen flanker task (Flanker task)
Time Frame: once before and after intake of bread for 3 weeks
Difference in cognitive control between and within intervention groups after the intake of bread for 3 weeks
once before and after intake of bread for 3 weeks
Working memory performance using a modified N-back task combined with recent-probes item-recognition task (Sternberg task)
Time Frame: once before and after intake of bread for 3 weeks
Difference in working memory between and within intervention groups after the intake of bread for 3 weeks
once before and after intake of bread for 3 weeks
Electrocardiogram (ECG) using the Biopac system
Time Frame: once before and after intake of bread for 3 weeks
Difference in heart rate variability during a stress test between and within intervention groups after the intake of bread for 3 weeks
once before and after intake of bread for 3 weeks
Electrodermal activity (EDA) using the Biopac system
Time Frame: once before and after intake of bread for 3 weeks
Difference in skin conductivity during a stress test between and within intervention groups after the intake of bread for 3 weeks. Electrodes to measure EDA will be placed on the subjects' left palm. Skin conductivity measures will include skin conductivity level (SCL), the number of skin conductivity responses (SCR), and the amplitude of SCR.
once before and after intake of bread for 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Örebro University, Sweden

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rebecca Wall, PhD, Örebro University, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 3, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 3, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 5, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Dnr 2020-03709

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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