The Role of Milk Derived Peptides on Glycaemic Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Glucose Disposal Rate
研究概览
简要总结
This study aims to ascertain the potential of novel milk derived hydrolysates to improve glycaemic control to promote metabolic health. A comprehensive characterisation of the metabolic response to these milk derived hydrolysates will ascertain the effect of the hydrolysates in terms of insulin sensitivity. These hydrolysates have been shown to improve insulin resistance in cell and animal models. Therefore the investigators aim is to test their efficacy in overweight, insulin resistant individuals at risk of developing type 2 diabetes.
详细描述
Recent figures estimate 60% of Irish adults are overweight or obese. As obesity is associated with the development of insulin resistance, which precedes type 2 diabetes development by decades, novel food based solutions are required to improve glycaemic control and attenuate insulin resistance.
In the current study insulin resistant individuals will undergo 4 study visits, 1 screening visit and 3 subsequent visits. At each of the 3 visits they will receive an oral lipid load consisting of 100mL soya bean oil, followed by either a water control; the hydrolysate being tested or the parent protein from which the hydrolysate was derived. After which they will undergo a 4 hour hyperinsulinemic-euglycaemic clamp at each visit to assess their insulin sensitivity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 - 65 years
- •BMI > 26 kg/m2
- •Prepared to maintain a constant body weight for the duration of the study
- •Free of any chronic or infectious disease
- •Not taking any medication for the regulation of blood sugars
- •Diet controlled type 2 diabetes
- •Free of any milk allergies or lactose intolerance
- •Without anaemia
排除标准
- •<18 or >65 years
- •Diabetes (pharmacologically treated) or other endocrine disorders.
- •Chronic inflammatory conditions.
- •Kidney or liver dysfunction.
- •Anaemia (Haemoglobin <12g/dl men, < 11g/dl women).
- •Taking any medication for the regulation of blood sugars.
结局指标
主要结局
Glucose Disposal Rate
时间窗: 12 weeks
M-value (mg/kg/min) /Glucose disposal rate will be used to measure of insulin sensitivity
次要结局
- Markers of glycaemic control(12 weeks)
- Lipid Profile(12 weeks)
- Inflammatory Markers(12 weeks)
研究者
Prof Helen M Roche
Associate Professor
University College Dublin