NCT04702672

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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	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	100% 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.

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-07-01
• Completion: 2024-07-31
• First posted: 2021-01-11
• Last updated: 2024-11-14

Locations

1 site across 1 country: Denmark