Type 2 DiabetesNCT04646746
Acute Studies on the Glycemic Index After Intake of Different Sorts of Barley in Subjects With Type 2 Diabetes
A study testing 100% wheat, 50% nude barley and 50% wheat and 75% nude barley and 25% wheat in people with Type 2 Diabetes, run by University of Aarhus at 1 site in Denmark.
Trial summary
In a series of double-blinded randomized cross-over acute studies, the investigators want to study the effects of different types of barley on the glycemic index (GI) in subjects with type 2 diabetes. The most common type of barley in Denmark is with rind and demands processing before use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- 100% wheat, 50% nude barley and 50% wheat and 75% nude barley and 25% wheat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 8 Feb 2021to 29 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes (T2D) defined by standard Danish guidelines.
- HbA1c between 48-78 mmol/l.
- Treatment with drugs for hypertension and high cholesterol is allowed if the treatment dose is stable and does not demand changes during the study period.
- Participants are encouraged to maintain their present psychical activity level and their smoking and alcohol habits.
Who cannot join
- Type 1 diabetes
- Insulin demanding T2D
- Use of weekly administrated GLP-1 antagonist (e.g. ozempic, trulicity or byetta)
- Use of acarbose
- Significant cardiovascular, kidney, liver or endocrine comorbidity
- Significant psychiatric history
Show all 10Show fewer
- Treatment with steroids
- Alcohol or drug abuse
- Pregnancy or breastfeeding
- Legally incompetent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HIAMBA-1 - the Effects of Nude Barley and Gene-modified High-amylose Barley on Postprandial Glucose Metabolism in Subjects With Type 2 Diabetes
In a series of double-blinded randomized cross-over acute studies, the investigators want to study the effects of different types of barley on the glycemic index (GI) in subjects with type 2 diabetes.
The most common type of barley in Denmark is with rind and demands processing before use. Processing may remove important nutrients from the barley. Some of the original antiquity barley has a loose rind (nude barley), that falls off during harvesting, and thereby reduces the need for processing. The investigators want to study how this ancient type of barley affects GI.
Furthermore, some of the investigators collaborative partners have made it possible to increase the amount of amylose in regular barley by genetic modification. The investigators want to study the effect on GI of this new type of modified barley.
Read the detailed description
Approx. 60 mio. people worldwide live with diabetes and the prevalence is increasing. The increase is primarily due to obesity, unhealthy diet and lack of physical activity. Therefore, it is important to find dietary products that counteracts this development.
Intake of food with a low glycemic index (GI) reduces the risk of developing type 2 diabetes (T2D) and helps in the regulation of a preexisting diabetes.
Barley has shown some beneficial effects on GI compared with wheat, however, barley is not commonly used in bread making in Denmark.
The most common type of barley in Denmark is with rind and demands processing before use. Processing may remove important nutrients from the barley. Some of the original antiquity barley has a loose rind (nude barley), that falls of during harvesting, and thereby reduces the need for processing. However, it is not known how this ancient type of barley affects GI.
The composition of the starch in barley is of importance when the grain is degraded after consumption. The starch consists of both amylose (which is slowly degraded) and amylopectin (which is quickly degraded). By genetic modification, it was possible for collaborative researchers at the Universities of Aarhus and Copenhagen to increase the amount of amylose in regular barley. Slowly degraded starch is expected to decrease GI.
In a series of acute studies the investigators want to study the effects on the glucose metabolism to intake of bread made with different compositions of wheat, nude barley and gene-modified high-amylose barley in subjects with T2D.
It is expected that both nude barley and gene-modified high-amylose barley lowers the postprandial glycemic response more than wheat and hereby positively affect the glycemic regulation for subjects with type 2 diabetes.
- Conditions
- Type 2 Diabetes
- Being tested
- 100% wheat, 50% nude barley and 50% wheat, 75% nude barley and 25% wheat, 50% gene-modified high-amylose barley and 50% wheat
- Keywords
- Glycemic index, Postprandial, Barley
- 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.
100% wheatDietary supplement
100 g of bread backed with 100% wheat
50% nude barley and 50% wheatDietary supplement
100 g of bread backed with 50% nude barley and 50% wheat
75% nude barley and 25% wheatDietary supplement
100 g of bread backed with 75% of nude barley and 25% wheat
50% gene-modified high-amylose barley and 50% wheatDietary supplement
100 g of bread backed with 50% gene-modified high-amylose barley and 50% wheat
| Study group | Role | What they receive |
|---|---|---|
| 100 g of 100% wheat bread | Experimental | Intake of 250 ml of tap water and 100 g of bread baked with 100% wheat flour (regular commercial available wheat flour). Consumed over maximum 10 minutes at time 0 min after overnight fasting. At one of four visits. Receives: Dietary Supplement: 100% wheat |
| Nude barley 50% | Experimental | Intake of 250 ml of tap water and 100 g of bread baked with 50% nude barley flour and 50% wheat flour. Consumed over maximum 10 minutes at time 0 min after overnight fasting. At one of four visits.
Ancient nude barley naturally bred in corporation with PlantCarb ApS and researchers at Aarhus and Copenhagen Universities. The wheat flour is standard commercial available flour. Receives: Dietary Supplement: 50% nude barley and 50% wheat |
| Nude barley 75% | Experimental | Intake of 250 ml of tapwater and 100 g of bread baked with 75% nude barley flour and 25% wheat flour. Consumed over maximum 10 minutes at time 0 min after overnight fasting. At one of four visits.
Ancient nude barley naturally bred in corporation with PlantCarb ApS and researchers at Aarhus and Copenhagen Universities. The wheat flour is standard commercial available flour. Receives: Dietary Supplement: 75% nude barley and 25% wheat |
| Gen-modified high-amylose barley | Experimental | Intake of 250 ml of tap water and 100 g of bread baked with 50% gene-modified high-amylose barley and 50% wheat. Consumed over maximum 10 minutes at time 0 min after overnight fasting. At one of four visits.
The gene-modified barley is produced by researchers at Aarhus and Copenhagen Universities as published in 'Carciofi M, et al., Concerted suppression of all starch branching enzyme genes in barley produces amylose-only starch granules. BMC Plant Biol. 2012 Nov 21;12:223. doi: 10.1186/1471-2229-12-223' The wheat flour is standard commercial available flour. Receives: Dietary Supplement: 50% gene-modified high-amylose barley and 50% wheat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glycemic response
Area under the curve for glucose (mmol/L)
Measured: Change from -10 minutes to 240 minutes after bread intake (measured at time -10,0,10,20,30,45,60,90,120,150,180,210,240 minutes)
Secondary outcomes (6)
Postprandial insulin response
Area under the curve for insulin (pmol/L)
Measured: Change from -10 minutes to 240 minutes after bread (measured at time -10,0,10,20,30,45,60,90,120,150,180,210,240 minutes)
Postprandial glucagon response
Area under the curve for glucagon (pg/mL)
Measured: Change from -10 minutes to 240 minutes after bread (measured at time -10,0,10,20,30,45,60,90,120,150,180,210,240 minutes)
Postprandial triglyceride response
Area under the curve for triglyceride (mmol/L)
Measured: Change from -10 minutes to 240 minutes after bread (measured at time -10,0,30,60,120,180,240 minutes)
Postprandial free fatty acid response
Area under the curve for free fatty acids (mmol/L)
Measured: Change from -10 minutes to 240 minutes after bread (measured at time -10,0,30,60,120,180,240 minutes)
Postprandial GLP-1 (glucagon-like peptide-1) response
Area under the curve for GLP-1 (pmol/L)
Measured: Change from -10 minutes to 240 minutes after bread (measured at time -10,0,30,60,120,180,240 minutes)
Postprandial GIP (Glucose-dependent insulinotropic polypeptide) response
Area under the curve for GIP (pmol/L)
Measured: Change from -10 minutes to 240 minutes after bread (measured at time -10,0,30,60,120,180,240 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start8 Feb 2021
- Primary completion29 Oct 2021
- Study completion29 Oct 2021
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 Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, double-blinded, cross-over, acute, dietary intervention study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Innovation Fund Denmark
- Responsible party
- Sponsor
- Investigators
- Mette B Larsen, MD, PhD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04646746
- Sponsor's protocol ID
- HIAMBA-1
- Status last verified
- May 2022
- First submitted
- 16 Nov 2020
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bohl M, Gregersen S, Zhong Y, Hebelstrup KH, Hermansen K. Beneficial glycaemic effects of high-amylose barley bread compared to wheat bread in type 2 diabetes. Eur J Clin Nutr. 2024 Mar;78(3):243-250. doi: 10.1038/s41430-023-01364-x. Epub 2023 Nov 8.
PubMed 37940671
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIAMBA-1 - the Effects of Nude Barley and Gene-modified High-amylose Barley on Postprandial Glucose Metabolism in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04646746
- Acronym / sponsor ID
- HIAMBA-1
- Conditions
- Type 2 Diabetes
- Keywords
- Glycemic index, Postprandial, Barley
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Innovation Fund Denmark
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 29 Oct 2021 (actual)
- Study completion
- 29 Oct 2021 (actual)
- First posted
- 30 Nov 2020 (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.
In a series of double-blinded randomized cross-over acute studies, the investigators want to study the effects of different types of barley on the glycemic index (GI) in subjects with type 2 diabetes.
The most common type of barley in Denmark is with rind and demands processing before use. Processing may remove important nutrients from the barley. Some of the original antiquity barley has a loose rind (nude barley), that falls off during harvesting, and thereby reduces the need for processing. The investigators want to study how this ancient type of barley affects GI.
Furthermore, some of the investigators collaborative partners have made it possible to increase the amount of amylose in regular barley by genetic modification. The investigators want to study the effect on GI of this new type of modified barley.
Detailed description
Approx. 60 mio. people worldwide live with diabetes and the prevalence is increasing. The increase is primarily due to obesity, unhealthy diet and lack of physical activity. Therefore, it is important to find dietary products that counteracts this development.
Intake of food with a low glycemic index (GI) reduces the risk of developing type 2 diabetes (T2D) and helps in the regulation of a preexisting diabetes.
Barley has shown some beneficial effects on GI compared with wheat, however, barley is not commonly used in bread making in Denmark.
The most common type of barley in Denmark is with rind and demands processing before use. Processing may remove important nutrients from the barley. Some of the original antiquity barley has a loose rind (nude barley), that falls of during harvesting, and thereby reduces the need for processing. However, it is not known how this ancient type of barley affects GI.
The composition of the starch in barley is of importance when the grain is degraded after consumption. The starch consists of both amylose (which is slowly degraded) and amylopectin (which is quickly degraded). By genetic modification, it was possible for collaborative researchers at the Universities of Aarhus and Copenhagen to increase the amount of amylose in regular barley. Slowly degraded starch is expected to decrease GI.
In a series of acute studies the investigators want to study the effects on the glucose metabolism to intake of bread made with different compositions of wheat, nude barley and gene-modified high-amylose barley in subjects with T2D.
It is expected that both nude barley and gene-modified high-amylose barley lowers the postprandial glycemic response more than wheat and hereby positively affect the glycemic regulation for subjects with type 2 diabetes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Randomized, double-blinded, cross-over, acute, dietary intervention study
| Arm | Type | Receives |
|---|---|---|
| 100 g of 100% wheat bread | Experimental | Dietary Supplement: 100% wheatIntake of 250 ml of tap water and 100 g of bread baked with 100% wheat flour (regular commercial available wheat flour). Consumed over maximum 10 minutes at time 0 min after overnight fasting. At one of four visits. |
| Nude barley 50% | Experimental | Dietary Supplement: 50% nude barley and 50% wheatIntake of 250 ml of tap water and 100 g of bread baked with 50% nude barley flour and 50% wheat flour. Consumed over maximum 10 minutes at time 0 min after overnight fasting. At one of four visits. Ancient nude barley naturally bred in corporation with PlantCarb ApS and researchers at Aarhus and Copenhagen Universities. The wheat flour is standard commercial available flour. |
| Nude barley 75% | Experimental | Dietary Supplement: 75% nude barley and 25% wheatIntake of 250 ml of tapwater and 100 g of bread baked with 75% nude barley flour and 25% wheat flour. Consumed over maximum 10 minutes at time 0 min after overnight fasting. At one of four visits. Ancient nude barley naturally bred in corporation with PlantCarb ApS and researchers at Aarhus and Copenhagen Universities. The wheat flour is standard commercial available flour. |
| Gen-modified high-amylose barley | Experimental | Dietary Supplement: 50% gene-modified high-amylose barley and 50% wheatIntake of 250 ml of tap water and 100 g of bread baked with 50% gene-modified high-amylose barley and 50% wheat. Consumed over maximum 10 minutes at time 0 min after overnight fasting. At one of four visits. The gene-modified barley is produced by researchers at Aarhus and Copenhagen Universities as published in 'Carciofi M, et al., Concerted suppression of all starch branching enzyme genes in barley produces amylose-only starch granules. BMC Plant Biol. 2012 Nov 21;12:223. doi: 10.1186/1471-2229-12-223' The wheat flour is standard commercial available flour. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 diabetes (T2D) defined by standard Danish guidelines.
- HbA1c between 48-78 mmol/l.
- Treatment with drugs for hypertension and high cholesterol is allowed if the treatment dose is stable and does not demand changes during the study period.
- Participants are encouraged to maintain their present psychical activity level and their smoking and alcohol habits.
Key exclusion criteria (10 listed)
- Type 1 diabetes
- Insulin demanding T2D
- Use of weekly administrated GLP-1 antagonist (e.g. ozempic, trulicity or byetta)
- Use of acarbose
- Significant cardiovascular, kidney, liver or endocrine comorbidity
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 |
|---|---|---|
| 100% wheat100 g of bread backed with 100% wheat | Dietary supplement | 100 g of 100% wheat bread |
| 50% nude barley and 50% wheat100 g of bread backed with 50% nude barley and 50% wheat | Dietary supplement | Nude barley 50% |
| 75% nude barley and 25% wheat100 g of bread backed with 75% of nude barley and 25% wheat | Dietary supplement | Nude barley 75% |
| 50% gene-modified high-amylose barley and 50% wheat100 g of bread backed with 50% gene-modified high-amylose barley and 50% wheat | Dietary supplement | Gen-modified high-amylose barley |
Primary outcome
Postprandial glycemic response
Time frame: Change from -10 minutes to 240 minutes after bread intake (measured at time -10,0,10,20,30,45,60,90,120,150,180,210,240 minutes)
Area under the curve for glucose (mmol/L)
6 secondary outcomes
Postprandial insulin response
Time frame: Change from -10 minutes to 240 minutes after bread (measured at time -10,0,10,20,30,45,60,90,120,150,180,210,240 minutes)
Postprandial glucagon response
Time frame: Change from -10 minutes to 240 minutes after bread (measured at time -10,0,10,20,30,45,60,90,120,150,180,210,240 minutes)
Postprandial triglyceride response
Time frame: Change from -10 minutes to 240 minutes after bread (measured at time -10,0,30,60,120,180,240 minutes)
Postprandial free fatty acid response
Time frame: Change from -10 minutes to 240 minutes after bread (measured at time -10,0,30,60,120,180,240 minutes)
Postprandial GLP-1 (glucagon-like peptide-1) response
Time frame: Change from -10 minutes to 240 minutes after bread (measured at time -10,0,30,60,120,180,240 minutes)
Postprandial GIP (Glucose-dependent insulinotropic polypeptide) response
Time frame: Change from -10 minutes to 240 minutes after bread (measured at time -10,0,30,60,120,180,240 minutes)
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 6 May 2022.
- Derived from this study: PubMed 37940671Bohl M, Gregersen S, Zhong Y, Hebelstrup KH, Hermansen K. Beneficial glycaemic effects of high-amylose barley bread compared to wheat bread in type 2 diabetes. Eur J Clin Nutr. 2024 Mar;78(3):243-250. doi: 10.1038/s41430-023-01364-x. Epub 2023 Nov 8.
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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.
Mette B Larsen, MD, PhD principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 100% wheat, 50% nude barley and 50% wheat and 75% nude barley and 25% wheat in people with Type 2 Diabetes, run by University of Aarhus at 1 site in Denmark.
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 4 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 6 May 2022. 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 Denmark. 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 glycemic response (time frame: Change from -10 minutes to 240 minutes after bread intake (measured at time -10,0,10,20,30,45,60,90,120,150,180,210,240 minutes)). 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 NCT04646746, 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 6 May 2022.