Healthy DietFBSNCT06333717
Impact of Whole Grain Rye Bread on Health
A study testing Whole grain bread in people with Healthy Diet, run by Örebro University, Sweden at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Diet
- What is being tested?
- Whole grain bread
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteSweden
- Study dates
- 3 Mar 2021to 5 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-44 years
- Body mass index (BMI) 18,5-30 kg/m2 (normal weight or overweight)
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Whole grain bread, Control bread
- Keywords
- dietary fibre, microbiota, gut-brain axis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole grain breadDietary supplement
Consumption of high-fibre bread as a dietary supplementation
Control breadDietary supplement
Consumption of control bread as a dietary supplementation
| Study group | Role | What they receive |
|---|---|---|
| High-fibre bread | Experimental | Six slices (180 g) of whole grain rye bread divided over the meals during the day for 3 weeks Receives: 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 Receives: Dietary Supplement: Control bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Difference in gut microbiota composition in faecal samples between the study arms using 16S RNA gene sequencing
Measured: faecal samples collected before and after intake of bread for 3 weeks
Concentrations of circulatory short-chain fatty acids SCFA
Difference in blood levels of SCFA between and within intervention groups after intake of bread for 3 weeks
Measured: blood samples collected before and after intake of bread for 3 weeks
Concentrations of faecal SCFA
Difference in faecal levels of SCFA between and within intervention groups after intake of bread for 3 weeks
Measured: faecal samples collected before and after intake of bread for 3 weeks
Concentrations of blood glucagon like peptide-1 (GLP-1)
Difference in blood levels of GLP-1 between and within intervention groups after intake of bread for 3 weeks
Measured: blood samples collected before and after intake of bread for 3 weeks
Concentrations of blood glucagon like peptide-2 (GLP-2)
Difference in blood levels of GLP-2 between and within intervention groups after intake of bread for 3 weeks
Measured: blood samples collected before and after intake of bread for 3 weeks
Concentrations of blood peptide YY (PYY)
Difference in blood levels of PYY between and within intervention groups after intake of bread for 3 weeks
Measured: blood samples collected before and after intake of bread for 3 weeks
Concentrations of blood gastric inhibitory polypeptide (GIP)
Difference in blood levels of GIP between and within intervention groups after intake of bread for 3 weeks
Measured: blood samples collected before and after intake of bread for 3 weeks
Concentrations of blood neuroactive peptide Y (NPY)
Difference in blood levels of NPY between and within intervention groups after intake of bread for 3 weeks
Measured: blood samples collected before and after intake of bread for 3 weeks
Concentrations of blood brain-derived neurotrophic factor (BDNF)
Difference in blood levels of BDNF between and within intervention groups after intake of bread for 3 weeks
Measured: blood samples collected before and after intake of bread for 3 weeks
Concentrations of blood cytokines
Difference in blood levels of cytokines between and within intervention groups after intake of bread for 3 weeks
Measured: blood samples collected before and after intake of bread for 3 weeks
Concentrations of blood alkylresorcinols
Difference in blood levels of alkylresorcinols between and within intervention groups after intake of bread for 3 weeks
Measured: blood samples collected before and after intake of bread for 3 weeks
Concentrations of blood lipopolysaccharide-binding protein (LBP)
Difference in blood levels of LBP between and within intervention groups after intake of bread for 3 weeks
Measured: blood samples collected before and after intake of bread for 3 weeks
Concentrations of blood soluble CD-14 (sCD-14)
Difference in blood levels of sCD-14 between and within intervention groups after intake of bread for 3 weeks
Measured: blood samples collected before and after intake of bread for 3 weeks
Concentrations of sugars in urine
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
Measured: urine samples collected before and after intake of bread for 3 weeks
Concentrations of saliva cortisol during stress test
Difference in saliva levels of cortisol produced during stress test between and within intervention groups after intake of bread for 3 weeks
Measured: 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
Difference in saliva levels of a-amylase produced during stress test between and within intervention groups after intake of bread for 3 weeks
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start3 Mar 2021
- Primary completion3 Mar 2021
- Study completion5 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy DietStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca Wall, PhD, Principal investigator, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333717
- Sponsor's protocol ID
- Dnr 2020-03709
- Acronym
- FBS
- Status last verified
- Mar 2024
- First submitted
- 28 Feb 2024
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Whole Grain Rye Bread on Modulating Microbiota-gut-brain Axis in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06333717
- Acronym / sponsor ID
- FBS / Dnr 2020-03709
- Conditions
- Healthy Diet
- Keywords
- dietary fibre, microbiota, gut-brain axis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 3 Mar 2021 (actual)
- Study completion
- 5 Nov 2021 (actual)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-fibre bread | Experimental | Dietary Supplement: Whole grain breadSix slices (180 g) of whole grain rye bread divided over the meals during the day for 3 weeks |
| Control bread | Placebo comparator | Dietary Supplement: Control breadSix slices (180 g) of control bread containing refined wheat and oat flour divided over the meals during the day for 3 weeks |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18-44 years
- Body mass index (BMI) 18,5-30 kg/m2 (normal weight or overweight)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole grain breadConsumption of high-fibre bread as a dietary supplementation | Dietary supplement | High-fibre bread |
| Control breadConsumption of control bread as a dietary supplementation | Dietary supplement | Control bread |
Primary outcome
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
16 secondary outcomes
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
Concentrations of circulatory short-chain fatty acids SCFA
Time frame: 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
Concentrations of blood glucagon like peptide-1 (GLP-1)
Time frame: 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
Concentrations of blood peptide YY (PYY)
Time frame: 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
Concentrations of blood neuroactive peptide Y (NPY)
Time frame: 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
Concentrations of blood cytokines
Time frame: 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
Concentrations of blood lipopolysaccharide-binding protein (LBP)
Time frame: 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
Concentrations of sugars in urine
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Wall, PhD principal investigator
Örebro University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole grain bread in people with Healthy Diet, run by Örebro University, Sweden at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.