Assessment of Insulin Sensitivity in Insulin-Resistant Subjects Fed Fish Protein
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Insulin sensitivity at 4 weeks
研究概览
简要总结
The objective of our research project is to determine the effects of fish protein, present in fish, on insulin sensitivity in insulin-resistant human individuals, and its mechanism of action on glucose metabolism. Our hypothesis is that fish protein improves insulin sensitivity, glucose tolerance and plasma lipid profile through an improvement in a primary defect in insulin signaling in overweight and insulin-resistant subjects.
详细描述
Recent data show that cod protein prevents the development of insulin resistance in rats. Dietary fish protein may also enhance insulin sensitivity in overweight insulin-resistant subjects by improving a primary defect in insulin signaling to PI 3-kinase, leading to reduced activation of the downstream effectors Akt and PKC. To determine whether this is the case, we will study the effects of fish protein on insulin sensitivity in humans, and how it improves the ability of muscles to use glucose. Such studies will help to advise individuals with insulin resistance or type 2 diabetes about eating fish.
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
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •overweight or obese (BMI between 25 and 40 kg /m2)
- •waist circumference above 88 cm for women and 102 cm for men
- •fasting plasma insulin above 90 pmol/L
- •fasting plasma glucose below 7.0 mmol/L and 2-h plasma glucose below 11.1 mmol/L
排除标准
- •Individuals with diagnosed diabetes or any chronic, metabolic or acute disease
- •Individuals who had a major surgery within the last 3 months
- •Individuals who had a significant weight loss (±10%) within the last 6 months
- •Individuals taking any medication known to affect lipid or glucose metabolism
- •Subjects with dietary incompatibility with fish consumption (allergy, intolerance or dislike) and/or calcium supplementation
结局指标
主要结局
Insulin sensitivity at 4 weeks
Insulin signaling in skeletal muscle at 4 weeks
次要结局
- plasma lipids and lipoproteins at 4 weeks
- plasma inflammatory markers at 4 weeks
- glucose tolerance at 4 weeks