Influence of Intervention With n-3 PUFA-supplemented Products in Moderate Hypertriglyceridemic Patients on Cardiovascular Risk Factors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- blood lipids (total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), TAG)
研究概览
简要总结
The study was performed to investigate the effects of a daily consumption of n-3 PUFA supplemented products (sausage, bread rolls, wafers, milk beverage) on cardiovascular risk factors in hypertriglyceridemic patients.
详细描述
Recent studies suggest that n-3 LC-PUFA intake might be useful to prevent coronary heart diseases.
As a precondition for participating in this study, the patients were provided information in writing and verbally about the details of the study. Written informed consent was obtained from all volunteers. Before the beginning of the study, all participants were subject to a medical examination by their general practitioners. Sixty hypertriglyceridemic patients (with triacylglyceride (TAG) values ≥ 150 mg/dl or ≥ 1.7 mmol/L) should entered the study.
The placebo-controlled, randomized double-blind cross-over study consists of two investigation periods of 10 weeks, with a ten-week washout period in between. After the washout period the intervention was crossed between the groups and the respective products were consumed for another 10 weeks. Patients in the placebo period receive 60g sausage, 2 bread rolls (2x50g), 2 wafers and one bottle of the milk beverage daily. These products were enriched with sunflower oil (20g/d).
In the intervention period, the products (60g sausage, 2 bread rolls (2x50g), 2 wafers and one bottle of the milk beverage) were enriched with a) 20g linseed oil, b) 20g echium oil, and c)12g microalgae powder. The daily dose of special n-3 fatty acid amounted to a) 10g alpha linolenic acid (ALA), b 2g stearidonic acid (SDA)+6g ALA, or c) 2g docosahexaenoic acid (DHA).
Venous blood is collected at the beginning and at the end of each period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •TAG values ≥ 150 mg/dl or ≥ 1.7 mmol/L
排除标准
- •Lipid lowering medications
- •Glucocorticoids
- •Gastrointestinal or metabolic diseases (e.g., diabetes mellitus, hyperthyroidism or hypothyroidism, hypercholesteremic patients with familial previous impacts)
- •Daily alcohol abuse
- •Taking dietary supplements (e. g., fish oil capsules, vitamin E)
- •Known allergies or foodstuff indigestibility
结局指标
主要结局
blood lipids (total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), TAG)
时间窗: 10 weeks
次要结局
- vascular cell adhesion molecule(10 weeks)
- lipoprotein a(10 weeks)
- blood pressure(10 weeks)
- high sensitive C-reactive protein(10 weeks)
- oxidised LDL(10 weeks)
- intracellular adhesion molecule(10 weeks)
- fatty acid distribution in plasma lipids and erythrocyte membranes(10 weeks)
研究者
Gerhard Jahreis
Proffessor
University of Jena