Type 2 DiabetesNCT04702672
High-amylose Barley (HIAMBA) in the Regulation and Prevention of Type 2 Diabetes
A study testing 100% Lean-baking barley® and 100% regular barley 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 naturally produced high-amylose barley (Lean-baking barley®) on the postprandial glucose-metabolism in subjects with and without type 2 diabetes (T2D). 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?
- 100% Lean-baking barley® and 100% regular barley
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2023to 31 Jul 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
- T2D defined by standard Danish guidelines.
- HbA1c between 42-78 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: High-amylose Barley (HIAMBA) in the Regulation and Prevention of Type 2 Diabetes: a Randomized, Cross-over, Acute Dietary Intervention Study.
In a series of double-blinded randomized cross-over acute studies, the investigators want to study the effects of naturally produced high-amylose barley (Lean-baking barley®) on the postprandial glucose-metabolism in subjects with and without type 2 diabetes (T2D).
Read the detailed description
The prevalence of T2D is increasing worldwide, primarily due to obesity, lack of physical activity and unhealthy diet. Therefore, it is of great important to evolve dietary products that counteracts this development.
Barley has shown some beneficial effects on postprandial blood glucose compared with wheat. A lowering of the postprandial glucose level reduces the risk of developing T2D and helps in the regulation of a pre-existing diabetes. However, barley is traditionally not used in bread-making in Denmark.
The elevation of postprandial glucose also depends on how fast the dietary products are degraded in the gastrointestinal tract.
The starch in barley consist of both fastly degraded amylopectin and slowly degraded amylose. Slow degradation is expected to lower postprandial glucose. By natural breeding techniques it has been possible for the investigators collaborative partners at the Universities of Aarhus and Copenhagen and PlantCarb ApS to make an natural organic high-amylose barley (Lean-baking barley®).
In a series of acute studies the investigators want to study the effects on the glycemic response to bread made with different flours (wheat, regular barley, Lean-baking barley® in subjects with T2D.
The investigators expect that Lean-baking barley® positively affect the postprandial glucose-metabolism more than wheat and regular barley and hereby acutely improves the glycemic regulation for both subjects with and without T2D.
- Conditions
- Type 2 Diabetes
- Being tested
- 100% wheat (control), 100% Lean-baking barley®, 100% regular barley
- Keywords
- Glycemic index, Postprandial, Barley, High-amylose
- 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% wheat (control)Dietary supplement
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.
100% Lean-baking barley®Dietary supplement
Intake of 250 ml of tap water and 100 g of bread baked with 100% Lean-baking barley® flour. Consumed over maximum 10 minutes at time 0 min after overnight fasting. At one of four visits.
HIAMBA® are naturally bred in corporation with PlantCarb ApS and researchers at Aarhus and Copenhagen Universities. The wheat flour is standard commercial available flou
100% regular barleyDietary supplement
Intake of 250 ml of tap water and 100 g of bread baked with 100% regular barley flour and 25% wheat flour. Consumed over maximum 10 minutes at time 0 min after overnight fasting. At one of four visits.
HIAMBA® are naturally bred in corporation with PlantCarb ApS and researchers at Aarhus and Copenhagen Universities. The wheat flour is standard commercial available flour.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetes | Experimental | Adults with T2D. Hemoglobin A1C between 42-78 mmol/l. No use of insulin or once-weekly glucagon-like peptide-1 (GLP-1) or acarbose. No severe cardiovascular, kidney, liver, psychiatric or endocrine disease. No abuse of alcohol- or narcotics. No pregnancy or lactation. Receives: Dietary Supplement: 100% wheat (control); Dietary Supplement: 100% Lean-baking barley®; Dietary Supplement: 100% regular barley |
| Non-diabetics | Experimental | Adults without T2D. No severe cardiovascular, kidney, liver, psychiatric or endocrine disease. No abuse of alcohol- or narcotics. No pregnancy or lactation. Receives: Dietary Supplement: 100% wheat (control); Dietary Supplement: 100% Lean-baking barley®; Dietary Supplement: 100% regular barley |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glycemic response
Postprandial glycemic response Area under the curve for glucose (mmol/L)
Measured: 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)
Secondary outcomes (7)
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)
Visual analogue scale (VAS)
VAS-score of a number of standardized questions regarding, hunger, satiety, the test meal experience etc. Each answer is ranged on a 100 mm line expressing the most positive and negative rating possible at each end.
Measured: Measured at time 0,30,60,90,120,150,180,210,240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start1 Jan 2023
- Primary completion1 Jul 2024
- Study completion31 Jul 2024
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, single-blinded, cross-over, acute, dietary intervention study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 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
- NCT04702672
- Sponsor's protocol ID
- HIAMBA-2
- Status last verified
- Nov 2024
- First submitted
- 9 Dec 2020
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bohl M, Gregersen S, Li Z, Blennow A, Hebelstrup KH, Hermansen K. High-amylose barley bread improves postprandial glycemia compared to regular barley and wheat bread in subjects with or without type 2 diabetes. Eur J Clin Nutr. 2025 Oct;79(10):1000-1006. doi: 10.1038/s41430-025-01646-6. Epub 2025 Jul 21.
PubMed 40691269
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-amylose Barley (HIAMBA) in the Regulation and Prevention of Type 2 Diabetes: a Randomized, Cross-over, Acute Dietary Intervention Study.
- ClinicalTrials.gov ID
- NCT04702672
- Acronym / sponsor ID
- HIAMBA-2
- Conditions
- Type 2 Diabetes
- Keywords
- Glycemic index, Postprandial, Barley, High-amylose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Innovation Fund Denmark
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 11 Jan 2021 (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 naturally produced high-amylose barley (Lean-baking barley®) on the postprandial glucose-metabolism in subjects with and without type 2 diabetes (T2D).
Detailed description
The prevalence of T2D is increasing worldwide, primarily due to obesity, lack of physical activity and unhealthy diet. Therefore, it is of great important to evolve dietary products that counteracts this development.
Barley has shown some beneficial effects on postprandial blood glucose compared with wheat. A lowering of the postprandial glucose level reduces the risk of developing T2D and helps in the regulation of a pre-existing diabetes. However, barley is traditionally not used in bread-making in Denmark.
The elevation of postprandial glucose also depends on how fast the dietary products are degraded in the gastrointestinal tract.
The starch in barley consist of both fastly degraded amylopectin and slowly degraded amylose. Slow degradation is expected to lower postprandial glucose. By natural breeding techniques it has been possible for the investigators collaborative partners at the Universities of Aarhus and Copenhagen and PlantCarb ApS to make an natural organic high-amylose barley (Lean-baking barley®).
In a series of acute studies the investigators want to study the effects on the glycemic response to bread made with different flours (wheat, regular barley, Lean-baking barley® in subjects with T2D.
The investigators expect that Lean-baking barley® positively affect the postprandial glucose-metabolism more than wheat and regular barley and hereby acutely improves the glycemic regulation for both subjects with and without T2D.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized, single-blinded, cross-over, acute, dietary intervention study
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetes | Experimental | Dietary Supplement: 100% wheat (control), Dietary Supplement: 100% Lean-baking barley®, Dietary Supplement: 100% regular barleyAdults with T2D. Hemoglobin A1C between 42-78 mmol/l. No use of insulin or once-weekly glucagon-like peptide-1 (GLP-1) or acarbose. No severe cardiovascular, kidney, liver, psychiatric or endocrine disease. No abuse of alcohol- or narcotics. No pregnancy or lactation. |
| Non-diabetics | Experimental | Dietary Supplement: 100% wheat (control), Dietary Supplement: 100% Lean-baking barley®, Dietary Supplement: 100% regular barleyAdults without T2D. No severe cardiovascular, kidney, liver, psychiatric or endocrine disease. No abuse of alcohol- or narcotics. No pregnancy or lactation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- T2D defined by standard Danish guidelines.
- HbA1c between 42-78 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% wheat (control)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. | Dietary supplement | Non-diabetics, Type 2 diabetes |
| 100% Lean-baking barley®Intake of 250 ml of tap water and 100 g of bread baked with 100% Lean-baking barley® flour. Consumed over maximum 10 minutes at time 0 min after overnight fasting. At one of four visits. HIAMBA® are naturally bred in corporation with PlantCarb ApS and researchers at Aarhus and Copenhagen Universities. The wheat flour is standard commercial available flou | Dietary supplement | Non-diabetics, Type 2 diabetes |
| 100% regular barleyIntake of 250 ml of tap water and 100 g of bread baked with 100% regular barley flour and 25% wheat flour. Consumed over maximum 10 minutes at time 0 min after overnight fasting. At one of four visits. HIAMBA® are naturally bred in corporation with PlantCarb ApS and researchers at Aarhus and Copenhagen Universities. The wheat flour is standard commercial available flour. | Dietary supplement | Non-diabetics, Type 2 diabetes |
Primary outcome
Postprandial glycemic response
Time frame: 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)
Postprandial glycemic response Area under the curve for glucose (mmol/L)
7 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)
Visual analogue scale (VAS)
Time frame: Measured at time 0,30,60,90,120,150,180,210,240 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 14 Nov 2024.
- Derived from this study: PubMed 40691269Bohl M, Gregersen S, Li Z, Blennow A, Hebelstrup KH, Hermansen K. High-amylose barley bread improves postprandial glycemia compared to regular barley and wheat bread in subjects with or without type 2 diabetes. Eur J Clin Nutr. 2025 Oct;79(10):1000-1006. doi: 10.1038/s41430-025-01646-6. Epub 2025 Jul 21.
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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% Lean-baking barley® and 100% regular barley 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 14 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 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: 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 NCT04702672, 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 14 Nov 2024.