Healthy SubjectsNCT02427555
Effects of Barley Based Food Products on Metabolism and Gut Microflora
A study testing Barley kernel bread and white wheat bread in people with Healthy Subjects, run by Lund University at 1 site in Sweden.
Trial summary
The main objective is to investigate gut microflora composition in relation to cardiometabolic risk markers, and to investigate the effects of 3 days intervention with a barley kernel based product on these variables. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Barley kernel bread and white wheat bread
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2015to May 2016
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy men and women between 50-79 years and
- BMI between 19-28.
Who cannot join
- fasting blood glucose concentrations > 6,1 mmol/L,
- known metabolic disorders or gastrointestinal diseases or other disorders that can interfere with the results of the study.
- furthermore, the subjects should be non-smokers and
- consume a normal (non-vegetarian) diet as is recommended by the Nordic dietary guidelines.
- antibiotics or probiotics should not have been taken during four weeks prior to faeces donation.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Food for Health Science Centre, Medicon Village, Lund University
Lund, , SE-223 81 LUND
About this study
The main objective is to investigate gut microflora composition in relation to cardiometabolic risk markers, and to investigate the effects of 3 days intervention with a barley kernel based product on these variables.
Read the detailed description
100 subjects were invited to deliver faecal samples. From this cohort 40 subjects were chosen based on their gut microflora composition to participate in the Barley intervention.
- Conditions
- Healthy Subjects
- Being tested
- Barley kernel bread, white wheat bread
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Barley kernel breadOther
3 days intervention with barley kernel bread
white wheat breadOther
3 days intervention with white wheat bread
| Study group | Role | What they receive |
|---|---|---|
| Barley kernel bread | Experimental | Not described Receives: Other: Barley kernel bread |
| Whit wheat flour bread | Sham comparator | Not described Receives: Other: white wheat bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in glucose regulation
blood glucose concentrations are measured fasting and postprandially a standardised breakfast after interventions with barley based bread and white wheat bread, respectively
Measured: Changes in fasting and postprandial blood glucose concentrations after 3 days intervention with a barley based bread in comparison to 3 days intervention with a white wheat based bread
Changes in colonic microbiota composition after intervention with barley
Gut microbiota composition are characterised after interventions with barley based bread and white wheat bread, respectively
Measured: Changes in colonic microbiota composition after 3 days intervention with a barley based bread in comparison to 3 days intervention with a white wheat based bread
nucleotide polymorphisms (SNP in TCF7L2)
investigate nucleotide polymorphisms that associate with cardiometabolic traits, in particular the SNP in TCF7L2
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Göteborg University
- Responsible party
- Principal investigator, Anne Nilsson, Lund University
- Investigators
- Anne Nilsson, PhD, Principal investigator, Food for Health Science Centre, Medicon Village, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427555
- Sponsor's protocol ID
- AFC-Y8-2015
- Status last verified
- May 2016
- First submitted
- 17 Apr 2015
- Last updated
- 17 May 2016
- Results posted
- No
Publications
Sandberg J, Kovatcheva-Datchary P, Bjorck I, Backhed F, Nilsson A. Abundance of gut Prevotella at baseline and metabolic response to barley prebiotics. Eur J Nutr. 2019 Sep;58(6):2365-2376. doi: 10.1007/s00394-018-1788-9. Epub 2018 Jul 25.
PubMed 30046942
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Barley Based Food Products on Metabolism and Gut Microflora
- ClinicalTrials.gov ID
- NCT02427555
- Acronym / sponsor ID
- AFC-Y8-2015
- Conditions
- Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Göteborg University
- Study start
- Apr 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 28 Apr 2015 (estimated)
- 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.
The main objective is to investigate gut microflora composition in relation to cardiometabolic risk markers, and to investigate the effects of 3 days intervention with a barley kernel based product on these variables.
Detailed description
100 subjects were invited to deliver faecal samples. From this cohort 40 subjects were chosen based on their gut microflora composition to participate in the Barley intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Barley kernel bread | Experimental | Other: Barley kernel bread |
| Whit wheat flour bread | Sham comparator | Other: white wheat bread |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy men and women between 50-79 years and
- BMI between 19-28.
Key exclusion criteria (5 listed)
- fasting blood glucose concentrations > 6,1 mmol/L,
- known metabolic disorders or gastrointestinal diseases or other disorders that can interfere with the results of the study.
- furthermore, the subjects should be non-smokers and
- consume a normal (non-vegetarian) diet as is recommended by the Nordic dietary guidelines.
- antibiotics or probiotics should not have been taken during four weeks prior to faeces donation.
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 |
|---|---|---|
| Barley kernel bread3 days intervention with barley kernel bread | Other | Barley kernel bread |
| white wheat bread3 days intervention with white wheat bread | Other | Whit wheat flour bread |
Primary outcome
Changes in glucose regulation
Time frame: Changes in fasting and postprandial blood glucose concentrations after 3 days intervention with a barley based bread in comparison to 3 days intervention with a white wheat based bread
blood glucose concentrations are measured fasting and postprandially a standardised breakfast after interventions with barley based bread and white wheat bread, respectively
Changes in colonic microbiota composition after intervention with barley
Time frame: Changes in colonic microbiota composition after 3 days intervention with a barley based bread in comparison to 3 days intervention with a white wheat based bread
Gut microbiota composition are characterised after interventions with barley based bread and white wheat bread, respectively
nucleotide polymorphisms (SNP in TCF7L2)
Time frame: at baseline
investigate nucleotide polymorphisms that associate with cardiometabolic traits, in particular the SNP in TCF7L2
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 17 May 2016.
- Derived from this study: PubMed 30046942Sandberg J, Kovatcheva-Datchary P, Bjorck I, Backhed F, Nilsson A. Abundance of gut Prevotella at baseline and metabolic response to barley prebiotics. Eur J Nutr. 2019 Sep;58(6):2365-2376. doi: 10.1007/s00394-018-1788-9. Epub 2018 Jul 25.
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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.
Anne Nilsson, PhD principal investigator
Food for Health Science Centre, Medicon Village, Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Barley kernel bread and white wheat bread in people with Healthy Subjects, run by Lund University 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 5 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 17 May 2016. 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?
Changes in glucose regulation (time frame: Changes in fasting and postprandial blood glucose concentrations after 3 days intervention with a barley based bread in comparison to 3 days intervention with a white wheat based bread). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02427555, which also lists 1 linked publication.
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 17 May 2016.