Comparison of Effect of Animal and Plant Sources of Omega-3 PUFA in Prevention of Cardiovascular and Metabolic Diseases
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Change in total cholesterol from baseline
研究概览
简要总结
The study is aimed to assess the efficacy of animal, plant sources of omega-3 polyunsaturated fatty acids and omega-3 pharmacological supplements on obesity, metabolic syndrome and cardiovascular disease.
详细描述
More than four million people in Europe (47%) and more than 1.9 million people in European Union (EU) (40%) die of cardiovascular diseases (CVD) every year. CVD mortality in EU is 43% in women and 36% in men. In Central and Eastern Europe, much more people die of CVD than in Western, Northern and Southern European countries. The World Health Organization (WHO) states that number of deaths in Slovakia is much higher than in Western European countries, even higher than in V4 countries - Slovakia, Czech Republic, Poland and Hungary
In the first stage of the project fatty acids will be analyzed with the focus on the ratio of omega-6 and omega-3 polyunsaturated fatty acids in fatty food for normal consumption and in nutritional supplements containing omega-3 polyunsaturated fatty acids.
In the second phase of the project risk factors of cardiovascular diseases for people without and people with a history of cardiovascular disease will be monitored and compared. There will be monitored and compared a wide range of laboratory markers of clinical biochemistry, immunology, pathological physiology in order to determine cardiovascular risk for men and women in different age categories.
The third stage will monitor the effect of natural plant and animal sources and pharmacological nutritional supplements with omega-3 polyunsaturated fatty acids on obesity, metabolic syndrome and cardiovascular risk factors.
The aim of this study is to assess the efficacy of animal, plant sources of omega-3 polyunsaturated fatty acids and omega-3 pharmacological supplements on obesity, metabolic syndrome and cardiovascular disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for obese participants were BMI≥29, age ≥18 and non-smokers, cardiovascular diseases. metabolic syndrome, obesity
- •for healthy participants with normal weight, inclusion criteria BMI25, age ≥18, non-smokers
排除标准
- •for all participants were cancer, inflammatory diseases, tuberculosis, renal and hepatic insufficiency, and pregnancy
- •for healthy participants without cardiovascular diseases, obesity and metabolic syndrome
结局指标
主要结局
Change in total cholesterol from baseline
时间窗: 6 months
percentual change in total cholesterol (mmoL/L) from baseline to 6months followup - total genetic analysis, extracellular DNA
glucose levels
时间窗: 6 months
fasting glucose in mmoL/L
Bile acids in serum
时间窗: 6 months
Concentration of serum bile acids (pg/mL)
Systemic inflammation activity
时间窗: 1 months
Interleukin 1 levels, interleukin 6 levels (pg/mL)
Body mass index
时间窗: 6 months
BMI kg/m2 6 months change.
Change in estrogen concentration
时间窗: 6 months
Assesment of concentration of estrogen (ng/mL)
Catalase activity
时间窗: 6 months
Determination of Catalase activity by electron microscopy
Antioxidant status
时间窗: 18 months
Determination of total antioxidant capacity (mmoL/L)
Superoxide dismutase activity
时间窗: 6 months
Determination of Superoxide dismutase activity by electron microscopy
Tissue concentrations of nitric oxide
时间窗: 6months
Determination of nitric oxide synthetase activity by electron microscopy
NF kappa B activity
时间窗: 6 months
Determination of NF kappa B activity by electron microscopy
次要结局
未报告次要终点
研究者
Martin Janičko
Assistant professor
Pavol Jozef Safarik University