The Effects of a Low-fat Spread With Added Plant Sterol Esters and Fish Omega-3 Fatty Acids on Blood Lipids
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Change in TG concentrations
研究概览
简要总结
The main aim of the study is to investigate the effect of daily consumption of a margarine enriched with plant sterol esters and fish oil on fasting triglycerides (TG) concentrations.
The study also aims to investigate the effect of plant sterols and fish oil on fasting total cholesterol (TC), Low-density lipoprotein cholesterol (LDL-C), High-density lipoprotein cholesterol (HDL-C) and non-HDL-C.
At last, the effect of plant sterols and fish oil on fasting apolipoprotein concentrations will be explored.
详细描述
The main aim of the study is to investigate the effect of daily consumption of a margarine enriched with plant sterol esters and fish oil on fasting TG concentrations.
The study also aims to investigate the effect of plant sterols and fish oil on fasting TC, LDL-C, HDL-C and non-HDL-C.
At last, the effect of plant sterols and fish oil on fasting apolipoprotein concentrations will be explored. This exploratory objective will only be analyzed if a relevant treatment effect on fasting triglycerides concentrations is observed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Fasting TG levels at screening: ≥ 1.40 and ≤ 5.60 mmol/L
- •Fasting LDL-C levels at screening: ≥ 3.4 and ≤ 4.9 mmol/L
排除标准
- •Recently (<6 months) diagnosed with cardiovascular event(s), revascularization or systemic inflammatory conditions.
- •Medical history which might impact study measurements, to be judged by the study physician
- •Use of over-the-counter and prescribed medication which may interfere with study measurements
- •Reported weight loss or gain of 3 kg or more during a period of 2 months prior to screening.
- •Currently smoking or being a non-smoker for less than 6 months and reported use of any nicotine containing products in the 6 months prior to screening and/or during the study.
结局指标
主要结局
Change in TG concentrations
时间窗: At baseline (after 2 weeks run-in period) and after 4 weeks intervention
Two samples will be taken at baseline (Day -1 and 1) and two samples at the end of intervention (Day 28 and 29)
次要结局
- Change in blood lipids(At baseline (after 2 weeks run-in period) and after 4 weeks intervention)