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| Name | Class |
|---|---|
| Innovation Fund Denmark | INDIV |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial glycemic response | Postprandial glycemic response Area under the curve for glucose (mmol/L) | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial insulin response | Area under the curve for insulin (pmol/L) | 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 |
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Inclusion Criteria for T2D group:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mette B Larsen, MD, PhD | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | 8200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40691269 | Derived | 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. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D005433 | Flour |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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Randomized, single-blinded, cross-over, acute, dietary intervention study
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Letter labeling of test products
| 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 barley | Dietary 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. |
|
Area under the curve for glucagon (pg/mL)
| 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) | 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) | 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) | 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) | 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 at time 0,30,60,90,120,150,180,210,240 minutes |
| D004700 | Endocrine System Diseases |