HIAMBA-1 - the Effects of Nude Barley and Gene-modified High-amylose Barley on Postprandial Glucose Metabolism in Subjects With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 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 different types of barley on the glycemic index (GI) in subjects with type 2 diabetes.
The most common type of barley in Denmark is with rind and demands processing before use. Processing may remove important nutrients from the barley. Some of the original antiquity barley has a loose rind (nude barley), that falls off during harvesting, and thereby reduces the need for processing. The investigators want to study how this ancient type of barley affects GI.
Furthermore, some of the investigators collaborative partners have made it possible to increase the amount of amylose in regular barley by genetic modification. The investigators want to study the effect on GI of this new type of modified barley.
详细描述
Approx. 60 mio. people worldwide live with diabetes and the prevalence is increasing. The increase is primarily due to obesity, unhealthy diet and lack of physical activity. Therefore, it is important to find dietary products that counteracts this development.
Intake of food with a low glycemic index (GI) reduces the risk of developing type 2 diabetes (T2D) and helps in the regulation of a preexisting diabetes.
Barley has shown some beneficial effects on GI compared with wheat, however, barley is not commonly used in bread making in Denmark.
The most common type of barley in Denmark is with rind and demands processing before use. Processing may remove important nutrients from the barley. Some of the original antiquity barley has a loose rind (nude barley), that falls of during harvesting, and thereby reduces the need for processing. However, it is not known how this ancient type of barley affects GI.
The composition of the starch in barley is of importance when the grain is degraded after consumption. The starch consists of both amylose (which is slowly degraded) and amylopectin (which is quickly degraded). By genetic modification, it was possible for collaborative researchers at the Universities of Aarhus and Copenhagen to increase the amount of amylose in regular barley. Slowly degraded starch is expected to decrease GI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
Color labeling
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes (T2D) defined by standard Danish guidelines.
- •HbA1c between 48-78 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.
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
研究组 & 干预措施
100 g of 100% wheat bread
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.
干预措施: 100% wheat (Dietary Supplement)
Nude barley 50%
Intake of 250 ml of tap water and 100 g of bread baked with 50% nude barley flour and 50% wheat flour. Consumed over maximum 10 minutes at time 0 min after overnight fasting. At one of four visits.
Ancient nude barley naturally bred in corporation with PlantCarb ApS and researchers at Aarhus and Copenhagen Universities. The wheat flour is standard commercial available flour.
干预措施: 50% nude barley and 50% wheat (Dietary Supplement)
Nude barley 75%
Intake of 250 ml of tapwater and 100 g of bread baked with 75% nude barley flour and 25% wheat flour. Consumed over maximum 10 minutes at time 0 min after overnight fasting. At one of four visits.
Ancient nude barley naturally bred in corporation with PlantCarb ApS and researchers at Aarhus and Copenhagen Universities. The wheat flour is standard commercial available flour.
干预措施: 75% nude barley and 25% wheat (Dietary Supplement)
Gen-modified high-amylose barley
Intake of 250 ml of tap water and 100 g of bread baked with 50% gene-modified high-amylose barley and 50% wheat. Consumed over maximum 10 minutes at time 0 min after overnight fasting. At one of four visits.
The gene-modified barley is produced by researchers at Aarhus and Copenhagen Universities as published in 'Carciofi M, et al., Concerted suppression of all starch branching enzyme genes in barley produces amylose-only starch granules. BMC Plant Biol. 2012 Nov 21;12:223. doi: 10.1186/1471-2229-12-223' The wheat flour is standard commercial available flour.
干预措施: 50% gene-modified high-amylose barley and 50% wheat (Dietary Supplement)
结局指标
主要结局
Postprandial glycemic response
时间窗: 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)
Area under the curve for glucose (mmol/L)
次要结局
- Postprandial triglyceride response(Change from -10 minutes to 240 minutes after bread (measured at time -10,0,30,60,120,180,240 minutes))
- 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 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 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 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))