The Effect of n-3 Fatty Acids and Fish on Glucose and Lipid Metabolism in Subjects With Impaired Glucose Metabolism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Blood pressure
研究概览
简要总结
The aim of the project is to examine whether the sources of n-3 fatty acids and fish itself differ in their effects on glucose metabolism, lipid metabolism, blood pressure, and serum inflammatory markers. Lipidomic profiles and gene expression will be used for thorough assessment of the possible clinical changes. The study will compare the effects of alpha-linolenic acid containing vegetable oil, fatty fish, lean fish and control diet. The results of this project will help to identify the optimal source of n-3 fatty acids, and reveal the significance of the components of fish other than fatty acids. These data will be useful both nationally and internationally, since highly controlled dietary interventions utilizing new methodology are scarce.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 40-70 years
- •BMI 25-32 kg/m2
- •fasting plasma glucose 5.6-7.0 mmol/l
- •2 h plasma glucose in oral glucose tolerance test <=11 mmol/l
- •fasting serum total cholesterol <=7 mmol/l
- •fasting serum LDL cholesterol <=5 mmol/l
- •fasting serum triglycerides <=4 mmol/l
排除标准
- •any chronic disease or condition that hamper the ability to follow dietary intervention
- •chronic liver, thyroid or kidney disease
- •alcohol abuse
- •recent weight loss
- •recent myocardial infarction
- •corticosteroid therapy
- •psychiatric disorders which need drug treatment
- •cancer under treatment
- •fish allergy or other extensive food allergies
- •exceptional diets (like Atkin's or vegan diet)
结局指标
主要结局
Blood pressure
时间窗: Baseline and 12 weeks
Change in blood pressure
Glucose metabolism assessed by oral glucose tolerance test and frequently sampled intravenous glucose tolerance test
时间窗: Baseline and 12 weeks
change in glucose metabolism
Serum lipid profile
时间窗: Baseline and at 12 weeks
Change in serum lipid profile
Plasma and urine metabonomics
时间窗: Baseline and 12 weeks
Change in plasma and urine metabonomics
Serum inflammatory markers
时间窗: baseline and 12 weeks
Change in serum inflammatory markers
Plasma and adipose tissue lipidomic profile
时间窗: Baseline and 12 weeks
Change in plasma and adipose tissue lipidomic profile
Gene expression in adipose tissue and peripheral blood mononuclear cells
时间窗: Baseline and 12 weeks
Change in gene expression in adipose tissue and peripheral blood mononuclear cells
次要结局
- Reverse cholesterol transport(Baseline and 12 weeks)