High-amylose Barley (HIAMBA) in the Regulation and Prevention of Type 2 Diabetes: a Randomized, Cross-over, Acute Dietary Intervention Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Postprandial glycemic response
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Letter labeling of test products
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •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
结局指标
主要结局
Postprandial glycemic response
时间窗: 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)
次要结局
- 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))
- 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))
- 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))
- 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))
- Postprandial triglyceride response(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(Change from -10 minutes to 240 minutes after bread (measured at time -10,0,30,60,120,180,240 minutes))
- Visual analogue scale (VAS)(Measured at time 0,30,60,90,120,150,180,210,240 minutes)