High-amylose Barley (HIAMBA) in the Regulation and Prevention of Type 2 Diabetes

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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High-amylose Barley (HIAMBA) in the Regulation and Prevention of Type 2 Diabetes: a Randomized, Cross-over, Acute Dietary Intervention Study.

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Dietary Supplement: 100% wheat (control)
* Dietary Supplement: 100% Lean-baking barley®
* Dietary Supplement: 100% regular barley


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for T2D group: 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. Exclusion Criteria: 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 Treatment with steroids Alcohol or drug abuse Pregnancy or breastfeeding Legally incompetent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized, single-blinded, cross-over, acute, dietary intervention study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Type 2 diabetes<br>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. | Dietary Supplement: 100% wheat (control)<br>* 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.<br>Dietary Supplement: 100% Lean-baking barley®<br>* 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<br>Dietary Supplement: 100% regular barley<br>* 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.<br>|
| Experimental: Non-diabetics<br>Adults without T2D. No severe cardiovascular, kidney, liver, psychiatric or endocrine disease. No abuse of alcohol- or narcotics. No pregnancy or lactation. | Dietary Supplement: 100% wheat (control)<br>* 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.<br>Dietary Supplement: 100% Lean-baking barley®<br>* 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<br>Dietary Supplement: 100% regular barley<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Barley, Glycemic index, Postprandial, High-amylose