An Investigation Into the Effects of Krill Oil vs. Fish Oil on Markers of Cardiovascular Disease in Males With Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 主要终点
- Change in Plasma Triglycerides at 3 weeks
研究概览
简要总结
There is some evidence that dietary supplementation with fish oil has health benefits, especially in respect of some of the known risk factors for cardiovascular (heart) disease such as cardiac arrhythmia. However, supplies of fish oil are limited, and it is desirable to validate alternative sustainable sources of the important omega-3 fatty acid components. It has been suggested that oil from krill, which are small marine crustaceans, may be as effective or possibly more beneficial than fish oil, and may provide a more effective and beneficial supplement. Dietary management of cardiovascular health parameters (such as blood lipids)is becoming more and more important as the rising trends in obesity nationally and worldwide are leading to escalating incidence of diabetes and heart disease. The investigators propose to use some specific novel lipid measurements of cardiovascular risk to test this possibility in a group of men who, although generally healthy, show some risk factors in terms of their weight and metabolic profile.This pilot study will provide preliminary data to show whether krill oil has similar or different effects from fish oil on the cardiovascular health of overweight but otherwise healthy men, and in particular will provide detailed information on alterations in novel lipid markers of cardiovascular disease, which may be a better diagnostic tool than classical lipid measurements (e.g. serum cholesterol). The investigators have been developing and validating new techniques to measure emerging lipid markers of cardiovascular risk accurately and will continue to develop and investigate these techniques during the course of this project. The investigators hypothesise that krill oil will be more efficacious in reducing markers of risk relating to cardiovascular disease.
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
- Single (Participant)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •waist circumference ≥ 94cm
- •Plus any two of the below:
- •Raised triglycerides : ≥ 150 mg/dL (1.7 mmol/L)
- •Reduced HDL cholesterol: < 40 mg/dL (1.03 mmol/L)
- •Raised blood pressure: ≥ 130/85 mm Hg
- •Raised fasting plasma glucose: ≥ 100 mg/dL (5.6 mmol/L)
排除标准
- •Drug treatment for cardiovascular disease or diabetes,
- •currently taking fish oil supplements
- •Individuals who would require carers or guardians to make decisions
- •Known history of liver disease
结局指标
主要结局
Change in Plasma Triglycerides at 3 weeks
时间窗: Change from baseline at 3 weeks
Change in plasma triglycerides from baseline to midpoint
Change in plasma high density lipoprotein cholesterol at 3 weeks
时间窗: Change from baseline at 3 weeks
Change in plasma High density lipoprotein cholesterol from baseline to midpoint
Change in plasma glucose at 3 weeks
时间窗: Change from baseline at 3 weeks
Change in plasma glucose from baseline to midpoint
Change in waist circumference
时间窗: Change from baseline at 6 weeks
Change in waist circumference from baseline to endpoint
Change in systolic blood pressure
时间窗: Change from baseline at 6 weeks
Change in systolic blood pressure from baseline to endpoint
Change in Diastolic blood pressure
时间窗: Change from baseline at 6 weeks
Change in diastolic blood pressure from baseline to endpoint
Change in plasma triglycerides at 6 weeks
时间窗: Change from baseline at 6 weeks
Change in plasma triglycerides at baseline to endpoint
Change in plasma glucose at 6 weeks
时间窗: Change from baseline at 6 weeks
Change in plasma glucose from baseline to endpoint
Change from baseline high density lipoprotein cholesterol at 6 weeks
时间窗: Change from baseline at 6 weeks
Change in high density lipoprotein cholesterol from baseline to endpoint
次要结局
- Change in Body mass(Change from baseline at 6 weeks)
- Change in plasma total cholesterol(Change from baseline at 3 weeks)
- Change in body mass index(Change from baseline at 6 weeks)
- Change in plasma cholesterol at 6 weeks(Change from baseline at 6 weeks)
- Change in plasma insulin at 3 weeks(Change from baseline at 3 weeks)
- Change in plasma insulin at 6 weeks(Change from baseline at 6 weeks)
- Change in small, dense low density lipoprotein cholesterol at 6 weeks(Change from baseline at 6 weeks)
- Change in plasma low density lipoprotein cholesterol at 3 weeks(Change from baseline at 3 weeks)
- Change in plasma low density lipoprotein cholesterol at 6 weeks(Change from baseline at 6 weeks)
研究者
Ian G. Davies
Dr Ian G. Davies
Liverpool John Moores University