High-amylose Barley (HIAMBA) in the Regulation and Prevention of Type 2 Diabetes
- Conditions
- Type 2 Diabetes
- Interventions
- Dietary Supplement: 100% wheat (control)Dietary Supplement: 100% Lean-baking barley®Dietary Supplement: 100% regular barley
- Registration Number
- NCT04702672
- Lead Sponsor
- University of Aarhus
- Brief 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).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
Not provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Non-diabetics 100% wheat (control) Adults without T2D. No severe cardiovascular, kidney, liver, psychiatric or endocrine disease. No abuse of alcohol- or narcotics. No pregnancy or lactation. Type 2 diabetes 100% wheat (control) 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. Non-diabetics 100% Lean-baking barley® Adults without T2D. No severe cardiovascular, kidney, liver, psychiatric or endocrine disease. No abuse of alcohol- or narcotics. No pregnancy or lactation. Type 2 diabetes 100% regular barley 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. Type 2 diabetes 100% Lean-baking barley® 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. Non-diabetics 100% regular barley Adults without T2D. No severe cardiovascular, kidney, liver, psychiatric or endocrine disease. No abuse of alcohol- or narcotics. No pregnancy or lactation.
- Primary Outcome Measures
Name Time Method 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) Postprandial glycemic response Area under the curve for glucose (mmol/L)
- Secondary Outcome Measures
Name Time Method Postprandial glucagon response 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) Area under the curve for glucagon (pg/mL)
Postprandial free fatty acid response Change from -10 minutes to 240 minutes after bread (measured at time -10,0,30,60,120,180,240 minutes) Area under the curve for free fatty acids (mmol/L)
Postprandial GLP-1 (glucagon-like peptide-1) response Change from -10 minutes to 240 minutes after bread (measured at time -10,0,30,60,120,180,240 minutes) Area under the curve for GLP-1 (pmol/L)
Postprandial insulin response 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) Area under the curve for insulin (pmol/L)
Postprandial triglyceride response Change from -10 minutes to 240 minutes after bread (measured at time -10,0,30,60,120,180,240 minutes) Area under the curve for triglyceride (mmol/L)
Postprandial GIP (Glucose-dependent insulinotropic polypeptide) response Change from -10 minutes to 240 minutes after bread (measured at time -10,0,30,60,120,180,240 minutes) Area under the curve for GIP (pmol/L)
Visual analogue scale (VAS) Measured at time 0,30,60,90,120,150,180,210,240 minutes 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.
Trial Locations
- Locations (1)
Aarhus University Hospital
🇩🇰Aarhus, Denmark