Type 2 DiabetesBBNCT06673212
Black Barley Study - Barley to Support Food and Drink Innovation (RI-B7-3)
A study testing Berneray Bere barley bread and Black Barley bread in people with Type 2 Diabetes, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
Sustained postprandial hyperglycaemia is an independent risk factor for cardiovascular complications and death. Intensive glucose control is the predominant factor to prevent the development of chronic complications in Type 2 Diabetes Mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Berneray Bere barley bread and Black Barley bread
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Jul 2022to 28 Jun 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Apparently healthy male and female subjects with Diabetes Risk Score ≥ 7 points
Who cannot join
- Type 1 diabetes
- Type 2 diabetes controlled with medication
- Coeliac Disease
- Eating disorders (anorexia, bulimia, binge eating or night eating syndrome)
- Food allergies/intolerances
- Any significant health issues
Show all 9Show fewer
- Breastfeeding/ Pregnancy
- Addiction to any substances
- Are unable to give written informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Aberdeen, The Rowett Institute
Aberdeen, AB25 2ZD
About this study
Official title: Barley to Support Food and Drink Innovation (RI-B7-3)
Sustained postprandial hyperglycaemia is an independent risk factor for cardiovascular complications and death. Intensive glucose control is the predominant factor to prevent the development of chronic complications in Type 2 Diabetes Mellitus (T2DM). The investigators have shown that phytochemical-rich extracts (in this case anthocyanins and their derivatives) can attenuate glucose response and there is also strong evidence for the role of fibre. Here a selected barley line (rich in anthocyanins and (1,3;1,4)-β-glucan) will be compared to a control barley and control wheat in an acute human dietary intervention (with n=15 healthy volunteers) to explore the potential to modulate postprandial glycaemia and insulinaenemia. An additional secondary outcome will include metabolomics analysis of the blood plasma and urine to detect differences in bioactive compounds including phytochemical metabolites. This will help ensure that barley lines being bred for human food can also deliver benefits for health.
Read the detailed description
Barley is an important Scottish crop in terms of contributing to the distilling industry but underutilised as a healthy (and potentially sustainable food). The investigators have shown (unpublished data) that barleys entering the food supply chain are not bred for food but are often grain destined for distilling and not rich is components of value for human nutrition, for example (1,3;1,4)-β-glucan, micronutrient vitamins and minerals as well as bioactive phytochemicals associated with reduction of non-communicable diseases such as type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD).
Current research is exploring the potential of specifically bred food barleys to require less inputs in terms of nutrients and pesticides and grow on more marginal lands providing farmers with a crop harvested at a different time of year, mitigating against unpredictable weather and a changing climate. It is important that these barleys also deliver benefits to human health. There are established health claims with regard to the lipid lowering effect of (1,3;1,4)-β-glucan and phytochemical-rich barleys could also potentially reduce blood glucose, an important factor leading to metabolic deregulation and subsequent disease development. This would meet the needs of people choosing a healthy lifestyle, as well as those living with or at risk of T2DM. From the food collections being developed at the James Hutton Institute, an accession (high in (1,3;1,4)-β-glucan and phytochemicals) will be selected and tested in an acute dietary intervention to determine if postprandial blood glucose levels are reduced. This will be compared to control barley and wheat products.
- Conditions
- Type 2 Diabetes
- Being tested
- Control Wheat Bread, Berneray Bere barley bread, Black Barley bread
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control Wheat BreadOther
Ingredients: Wheat Flour, Salt, Water, Allinson's Dried Active Yeast, Sugar
Berneray Bere barley breadOther
Ingredients: Berneray Bere Barley Flour, Salt, Water, Allinson's Dried Active Yeast, Sugar
Black Barley breadOther
Ingredients: Black Barley Flour, Salt, Water, Allinson's Dried Active Yeast, Sugar
| Study group | Role | What they receive |
|---|---|---|
| Control Wheat Bread | Active comparator | Control Wheat Bread will be prepared to the same formulation as white wheat bread. Receives: Other: Control Wheat Bread |
| Berneray Bere barley bread | Experimental | Berneray Bere barley bread will be prepared to a formulation as for the white wheat bread, but the wheat flour will be replaced with Berneray Bere barley flour. Receives: Other: Berneray Bere barley bread |
| Black Barley bread | Experimental | Black Barley bread will be prepared to a formulation as for the white wheat bread, but the wheat flour will be replaced with Black Barley flour. Receives: Other: Black Barley bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial blood glucose levels
Modulation of postprandial blood glucose levels after acute consumption of the Black barley, Bere barley and the Wheat breads.
Measured: 5 hours
Postprandial insulin levels
Modulation of postprandial insulin levels after acute consumption of the Black barley, Bere barley and the Wheat breads.
Measured: 5 hours
Secondary outcomes (1)
Concentration of phytochemical metabolites in the systemic circulation
Changes in phytochemical metabolites after acute consumption of the Black barley, Bere barley and the Wheat breads.
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start27 Jul 2022
- Primary completion15 May 2023
- Study completion28 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wendy Russell, Principal investigator, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673212
- Sponsor's protocol ID
- ROW_2022_001
- Acronym
- BB
- Status last verified
- Nov 2024
- First submitted
- 31 Oct 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barley to Support Food and Drink Innovation (RI-B7-3)
- ClinicalTrials.gov ID
- NCT06673212
- Acronym / sponsor ID
- BB / ROW_2022_001
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Study start
- 27 Jul 2022 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 4 Nov 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.
Sustained postprandial hyperglycaemia is an independent risk factor for cardiovascular complications and death. Intensive glucose control is the predominant factor to prevent the development of chronic complications in Type 2 Diabetes Mellitus (T2DM). The investigators have shown that phytochemical-rich extracts (in this case anthocyanins and their derivatives) can attenuate glucose response and there is also strong evidence for the role of fibre. Here a selected barley line (rich in anthocyanins and (1,3;1,4)-β-glucan) will be compared to a control barley and control wheat in an acute human dietary intervention (with n=15 healthy volunteers) to explore the potential to modulate postprandial glycaemia and insulinaenemia. An additional secondary outcome will include metabolomics analysis of the blood plasma and urine to detect differences in bioactive compounds including phytochemical metabolites. This will help ensure that barley lines being bred for human food can also deliver benefits for health.
Detailed description
Barley is an important Scottish crop in terms of contributing to the distilling industry but underutilised as a healthy (and potentially sustainable food). The investigators have shown (unpublished data) that barleys entering the food supply chain are not bred for food but are often grain destined for distilling and not rich is components of value for human nutrition, for example (1,3;1,4)-β-glucan, micronutrient vitamins and minerals as well as bioactive phytochemicals associated with reduction of non-communicable diseases such as type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD).
Current research is exploring the potential of specifically bred food barleys to require less inputs in terms of nutrients and pesticides and grow on more marginal lands providing farmers with a crop harvested at a different time of year, mitigating against unpredictable weather and a changing climate. It is important that these barleys also deliver benefits to human health. There are established health claims with regard to the lipid lowering effect of (1,3;1,4)-β-glucan and phytochemical-rich barleys could also potentially reduce blood glucose, an important factor leading to metabolic deregulation and subsequent disease development. This would meet the needs of people choosing a healthy lifestyle, as well as those living with or at risk of T2DM. From the food collections being developed at the James Hutton Institute, an accession (high in (1,3;1,4)-β-glucan and phytochemicals) will be selected and tested in an acute dietary intervention to determine if postprandial blood glucose levels are reduced. This will be compared to control barley and wheat products.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Wheat Bread | Active comparator | Other: Control Wheat BreadControl Wheat Bread will be prepared to the same formulation as white wheat bread. |
| Berneray Bere barley bread | Experimental | Other: Berneray Bere barley breadBerneray Bere barley bread will be prepared to a formulation as for the white wheat bread, but the wheat flour will be replaced with Berneray Bere barley flour. |
| Black Barley bread | Experimental | Other: Black Barley breadBlack Barley bread will be prepared to a formulation as for the white wheat bread, but the wheat flour will be replaced with Black Barley flour. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Apparently healthy male and female subjects with Diabetes Risk Score ≥ 7 points
Key exclusion criteria (9 listed)
- Type 1 diabetes
- Type 2 diabetes controlled with medication
- Coeliac Disease
- Eating disorders (anorexia, bulimia, binge eating or night eating syndrome)
- Food allergies/intolerances
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 |
|---|---|---|
| Control Wheat BreadIngredients: Wheat Flour, Salt, Water, Allinson's Dried Active Yeast, Sugar | Other | Control Wheat Bread |
| Berneray Bere barley breadIngredients: Berneray Bere Barley Flour, Salt, Water, Allinson's Dried Active Yeast, Sugar | Other | Berneray Bere barley bread |
| Black Barley breadIngredients: Black Barley Flour, Salt, Water, Allinson's Dried Active Yeast, Sugar | Other | Black Barley bread |
Primary outcome
Postprandial blood glucose levels
Time frame: 5 hours
Modulation of postprandial blood glucose levels after acute consumption of the Black barley, Bere barley and the Wheat breads.
Postprandial insulin levels
Time frame: 5 hours
Modulation of postprandial insulin levels after acute consumption of the Black barley, Bere barley and the Wheat breads.
1 secondary outcome
Concentration of phytochemical metabolites in the systemic circulation
Time frame: 5 hours
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 12 Nov 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.
Wendy Russell principal investigator
University of Aberdeen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Berneray Bere barley bread and Black Barley bread in people with Type 2 Diabetes, run by University of Aberdeen at 1 site in United Kingdom.
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 1 inclusion and 9 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 12 Nov 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 United Kingdom. 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. 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?
Postprandial blood glucose levels (time frame: 5 hours). The study lists 2 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 12 Nov 2024.