Type 2 Diabetes
Conditions
Keywords
Glycemic index, Postprandial, Barley, High-amylose
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.
Interventions
DIETARY_SUPPLEMENT100% 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_SUPPLEMENT100% 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_SUPPLEMENT100% regular barley
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.
Sponsors
Innovation Fund Denmark
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Letter labeling of test products
Intervention model description
Randomized, single-blinded, cross-over, acute, dietary intervention study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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. |
| 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) |
Countries
Denmark
Outcome results
None listed