A Pilot Study in the Swiss Alps: Impact of Alpine Dairy Products on Blood Lipid Levels
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Change in fasting blood LDL-cholesterol level
研究概览
简要总结
Elevated blood lipid levels are one of the main risk factors for cardiovascular disease. To manage elevated blood lipid levels in otherwise healthy people at low risk of cardiovascular disease, lifestyle changes are recommended as the first treatment strategy. One of these changes concerns diet. Clinical observations by general practitioners in alpine regions of Switzerland have shown that consumption of dairy products produced from cows living and grazing at high altitudes can have a beneficial effect on blood lipid parameters. However, little clinical data is available on the effect of alpine dairy products on health-related markers. This pilot study aims to assess if replacing standard (non-alpine) dairy products by alpine dairy products in the daily diet among patients with elevated LDL-cholesterol levels could reduce the blood LDL-cholesterol levels.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old
- •Elevated lipid levels, namely: fasting LDL-cholesterol >3mmol/L and </=5mmol/L
- •Agreeing to eat 3 portions of dairy products daily (according to instructions)
排除标准
- •Eating less than two and more than six portions of dairy products daily
- •Body weight change +/-5% of body weight in the last three months
- •Secondary prevention treatment for cardiovascular disease
- •Moderate, high or very high cardiovascular risk according to AGLA score
- •Currently taking PSCK9-inhibitors, ezetimibe, statins, glucocorticoids
- •Poorly controlled, severe chronic renal insufficiency, hypothyroidism, cholestasis, nephrotic syndrome, eating disorders, alcohol abuse, Cushing syndrome
- •Myocardial infarction, percutaneous coronary intervention or coronary artery bypass grafting in the previous 6 months
- •Known lactose intolerance or dairy allergies
- •Change of diet less than 2 months before intervention
- •Pregnant or breastfeeding
- •Incapacity of judgement
- •Inability to speak and read German
结局指标
主要结局
Change in fasting blood LDL-cholesterol level
时间窗: Baseline, Day 15, Day 30 and Day 45
Measure of LDL-cholesterol in mmol/L
次要结局
- Change in total cholesterol, triglycerides, HDL-cholesterol and lipoprotein A(Baseline, Day 15, Day 30 and Day 45)