跳至主要内容
临床试验/NCT06673212
NCT06673212已完成不适用

Barley to Support Food and Drink Innovation (RI-B7-3)

University of Aberdeen2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2022年7月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
2
主要终点
Postprandial blood glucose levels

研究概览

简要总结

Sustained postprandial hyperglycaemia is an independent risk factor for cardiovascular complications and death. Intensive glucose control is the predominant factor to prevent the development of chronic complications in Type 2 Diabetes Mellitus (T2DM). The investigators have shown that phytochemical-rich extracts (in this case anthocyanins and their derivatives) can attenuate glucose response and there is also strong evidence for the role of fibre. Here a selected barley line (rich in anthocyanins and (1,3;1,4)-β-glucan) will be compared to a control barley and control wheat in an acute human dietary intervention (with n=15 healthy volunteers) to explore the potential to modulate postprandial glycaemia and insulinaenemia. An additional secondary outcome will include metabolomics analysis of the blood plasma and urine to detect differences in bioactive compounds including phytochemical metabolites. This will help ensure that barley lines being bred for human food can also deliver benefits for health.

详细描述

Barley is an important Scottish crop in terms of contributing to the distilling industry but underutilised as a healthy (and potentially sustainable food). The investigators have shown (unpublished data) that barleys entering the food supply chain are not bred for food but are often grain destined for distilling and not rich is components of value for human nutrition, for example (1,3;1,4)-β-glucan, micronutrient vitamins and minerals as well as bioactive phytochemicals associated with reduction of non-communicable diseases such as type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD).

Current research is exploring the potential of specifically bred food barleys to require less inputs in terms of nutrients and pesticides and grow on more marginal lands providing farmers with a crop harvested at a different time of year, mitigating against unpredictable weather and a changing climate. It is important that these barleys also deliver benefits to human health. There are established health claims with regard to the lipid lowering effect of (1,3;1,4)-β-glucan and phytochemical-rich barleys could also potentially reduce blood glucose, an important factor leading to metabolic deregulation and subsequent disease development. This would meet the needs of people choosing a healthy lifestyle, as well as those living with or at risk of T2DM. From the food collections being developed at the James Hutton Institute, an accession (high in (1,3;1,4)-β-glucan and phytochemicals) will be selected and tested in an acute dietary intervention to determine if postprandial blood glucose levels are reduced. This will be compared to control barley and wheat products.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Apparently healthy male and female subjects with Diabetes Risk Score ≥ 7 points

排除标准

  • Type 1 diabetes
  • Type 2 diabetes controlled with medication
  • Coeliac Disease
  • Eating disorders (anorexia, bulimia, binge eating or night eating syndrome)
  • Food allergies/intolerances
  • Any significant health issues
  • Breastfeeding/ Pregnancy
  • Addiction to any substances
  • Are unable to give written informed consent

结局指标

主要结局

Postprandial blood glucose levels

时间窗: 5 hours

Modulation of postprandial blood glucose levels after acute consumption of the Black barley, Bere barley and the Wheat breads.

Postprandial insulin levels

时间窗: 5 hours

Modulation of postprandial insulin levels after acute consumption of the Black barley, Bere barley and the Wheat breads.

次要结局

  • Concentration of phytochemical metabolites in the systemic circulation(5 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验