Metabolic SyndromeBarleybreadNCT02867215
Barley Bread and Metabolic Disease
A study testing Barley bread and Wheat bread in people with Metabolic Syndrome, run by University of Copenhagen.
Trial summary
The aim of this study was to compare the metabolic effects of consuming whole barley bread and whole wheat bread, in healthy subjects. Also, to investigate the effect of whole grain flour on mineral status. Read more about this study
- Who is it for?
- Ages 20 to 53 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Barley bread and Wheat bread
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Apr 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 20 to 53 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Like and tolerate wheat/ barley bread products.
- Age: 20 - 53 years
- Body mass index (BMI): 23 - 30 kg/m2
- Weight stable (<3 kg weight change during the last 6 months)
- Apparently healthy
- Informed consent signed
- Freezer capacity for 1 week bread provision
- Can attend all visits required for the study
Who cannot join
- Wheat/gluten or barley intolerance
- Smoking on a daily basis
- Lactating (or lactating within 6 weeks prior to study start), pregnant (or pregnant within 3 months prior to study start) or wish to become pregnant during the study
- Diagnosed with any form of diabetes or cardiovascular disease
- Reported chronic gastrointestinal disorders
- Taking dietary supplements during or one month prior to the study
Show all 10Show fewer
- Lack of cooperation and adherence to the protocol
- Use of prescription medication will be evaluated on an individual basis
- Blood donation within 3 months prior to study start or during the study
- Participation in other clinical trials
About this study
Official title: Whole Barley Bread: Effect on the Risk of Metabolic Disease and Other Health Effects
The aim of this study was to compare the metabolic effects of consuming whole barley bread and whole wheat bread, in healthy subjects. Also, to investigate the effect of whole grain flour on mineral status.
Read the detailed description
Generally, diet can be improved in order to lower diet-related diseases risk. However, the increasing prevalence rates of diet-related diseases indicate that, in practice, people's diet does not follow the recommendations. The intake of whole flour foods is consistently associated with reduced risk of type 2 diabetes and cardiovascular diseases in epidemiological studies, although the mechanisms of this association are unclear. Here the aim is to compare the metabolic effects and mineral status of consumption of diet containing wholemeal barley bread versus whole meal wheat bread in healthy subjects.
The intervention was designed as a randomized, cross over trial of 3-weeks duration. A total of 14 participants was included in the study. In one period subjects received WBB bread; in the second period, subjects received WWB bread. This bread is based on the recipe of Egyptian Baladi bread but formed in Danish buns form. Participants incorporated this bread into their normal habitual diet with regard to the study restrictions about other cereal food products. At the beginning and end of each intervention period blood was drawn and urine collected and stored for later analysis.
The primary outcomes of this study are evaluation of LDL-c, insulin and glucose levels evaluated by analysis of fasting blood samples. Furthermore, selected measures to evaluate SCFA level in blood is to be evaluated. Secondary outcomes include mineral status.
- Conditions
- Metabolic Syndrome
- Being tested
- Barley bread, Wheat bread
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Barley breadOther
120g barley bread per day for 3 weeks.
Wheat breadOther
120g wheat bread per day for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Barley bread | Active comparator | Two loaves, 2 x 120 g loaf/day for 3 weeks. Receives: Other: Barley bread |
| Wheat bread | Active comparator | Two loaves, 2 x 120 g loaf/day for 3 weeks. Receives: Other: Wheat bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-c levels evaluated by analysis of fasting blood samples
Evaluated by analysis of fasting blood samples
Measured: 8-9 weeks
Glucose levels evaluated by analysis of fasting blood samples
Evaluated by analysis of fasting blood samples
Measured: 8-9 weeks
Insulin levels evaluated by analysis of fasting blood samples
Evaluated by analysis of fasting blood samples
Measured: 8-9 weeks
Secondary outcomes (1)
Mineral status
Evaluation depends on the mineral. Either by Atom absorption, ICP-MS or spectrometry
Measured: 8-9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startSep 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arne Astrup, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02867215
- Sponsor's protocol ID
- H-15010303
- Acronym
- Barleybread
- Status last verified
- Aug 2016
- First submitted
- 19 Jul 2016
- Last updated
- 15 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Barley Bread: Effect on the Risk of Metabolic Disease and Other Health Effects
- ClinicalTrials.gov ID
- NCT02867215
- Acronym / sponsor ID
- Barleybread / H-15010303
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 15 Aug 2016 (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 aim of this study was to compare the metabolic effects of consuming whole barley bread and whole wheat bread, in healthy subjects. Also, to investigate the effect of whole grain flour on mineral status.
Detailed description
Generally, diet can be improved in order to lower diet-related diseases risk. However, the increasing prevalence rates of diet-related diseases indicate that, in practice, people's diet does not follow the recommendations. The intake of whole flour foods is consistently associated with reduced risk of type 2 diabetes and cardiovascular diseases in epidemiological studies, although the mechanisms of this association are unclear. Here the aim is to compare the metabolic effects and mineral status of consumption of diet containing wholemeal barley bread versus whole meal wheat bread in healthy subjects.
The intervention was designed as a randomized, cross over trial of 3-weeks duration. A total of 14 participants was included in the study. In one period subjects received WBB bread; in the second period, subjects received WWB bread. This bread is based on the recipe of Egyptian Baladi bread but formed in Danish buns form. Participants incorporated this bread into their normal habitual diet with regard to the study restrictions about other cereal food products. At the beginning and end of each intervention period blood was drawn and urine collected and stored for later analysis.
The primary outcomes of this study are evaluation of LDL-c, insulin and glucose levels evaluated by analysis of fasting blood samples. Furthermore, selected measures to evaluate SCFA level in blood is to be evaluated. Secondary outcomes include mineral status.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Barley bread | Active comparator | Other: Barley breadTwo loaves, 2 x 120 g loaf/day for 3 weeks. |
| Wheat bread | Active comparator | Other: Wheat breadTwo loaves, 2 x 120 g loaf/day for 3 weeks. |
Who may qualify
- Ages
- 20 to 53 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Like and tolerate wheat/ barley bread products.
- Age: 20 - 53 years
- Body mass index (BMI): 23 - 30 kg/m2
- Weight stable (<3 kg weight change during the last 6 months)
- Apparently healthy
Key exclusion criteria (10 listed)
- Wheat/gluten or barley intolerance
- Smoking on a daily basis
- Lactating (or lactating within 6 weeks prior to study start), pregnant (or pregnant within 3 months prior to study start) or wish to become pregnant during the study
- Diagnosed with any form of diabetes or cardiovascular disease
- Reported chronic gastrointestinal disorders
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 bread120g barley bread per day for 3 weeks. | Other | Barley bread |
| Wheat bread120g wheat bread per day for 3 weeks. | Other | Wheat bread |
Primary outcome
LDL-c levels evaluated by analysis of fasting blood samples
Time frame: 8-9 weeks
Evaluated by analysis of fasting blood samples
Glucose levels evaluated by analysis of fasting blood samples
Time frame: 8-9 weeks
Evaluated by analysis of fasting blood samples
Insulin levels evaluated by analysis of fasting blood samples
Time frame: 8-9 weeks
Evaluated by analysis of fasting blood samples
1 secondary outcome
Mineral status
Time frame: 8-9 weeks
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 15 Aug 2016.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Barley bread and Wheat bread in people with Metabolic Syndrome, run by University of Copenhagen.
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 8 inclusion and 10 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 15 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
LDL-c levels evaluated by analysis of fasting blood samples (time frame: 8-9 weeks). 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?
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 15 Aug 2016; AzTrials last refreshed its copy on 1 Nov 2026.