Effect of Plant Stanol Ester-Containing Spread Based on Extra Virgin Olive Oil on Estimated Cardiovascular Risk, and Lipid-Inflammatory-Haemostatic Factors in Comparison to Mediterranean Diet: A Randomized, Placebo-Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Primary endpoint: Change from baseline in cardiovascular (CVD) risk as assessed by the PROCAM and Framingham risk engines.
研究概览
简要总结
Since it is very difficult to have the real thing (Mediterranean diet) we need to find an alternative to reduce cardiovascular disease (CVD) risk in subjects with moderate hypercholesterolaemia (a major CVD risk factor) living in western countries. Therefore, this proposed study is designed to assess if giving olive oil supplements, with or without stanol ester, is equivalent to following a Mediterranean diet. Furthermore, the stanol-olive oil combination may prove to be superior to olive oil alone.
详细描述
Design: Randomised, double blind, placebo controlled study Number of participants: 150 (3 groups with 50 subjects each). Intervention: One group will be assigned to stanol ester spread (2 g/day) based on olive oil, another on spread with olive oil containing placebo stanol ester (in identical containers with the stanol ester spread). In the third group, a structured effort will be made to improve adherence to Mediterranean diet by at least 2 points in a 10-level scale. Adherence to the Mediterranean diet will be improved by a dietician with detailed explanation of the composition of the diet, preparation of several week specific programs according to dietary preferences of the specific subject. Dietician interviews with a 5 day questionnaire on consumed foods will establish the degree of adherence to Mediterranean diet.
Duration: 16 weeks (4 weeks of lifestyle advice and 12 weeks of treatment).
Prespecified analyses:
- Postmenopausal women vs women with child bearing potential.
- Older (>65 years of age) vs younger subjects,
- Subjects with impaired fasting glucose 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects over 45 years of age with mild hypercholesterolaemia (TC levels: 200 mg/dl - 230 mg/dl)
排除标准
- •Subjects with
- •Established CVD (coronary heart disease, peripheral arterial disease, aortic aneurysm, or symptomatic carotid artery disease) or T2DM
- •Chronic diseases (including liver diseases)
- •Pregnancy
- •Malignancies
- •Unwillingness to participate
结局指标
主要结局
Primary endpoint: Change from baseline in cardiovascular (CVD) risk as assessed by the PROCAM and Framingham risk engines.
时间窗: three months
次要结局
- Change from baseline in major CVD risk factors [TC, LDL-C, HDL-C, TG, apoB], in an inflammatory marker [C-reactive protein], in hemostatic parameters (PAI-I, fibrinogen), liver function tests at the end of the study vs baseline.(three months)