Effect of Plant Sterols Esterified to Fish Oil Fatty Acids on Plasma Lipid Levels in Healthy, Hyperlipidemic Subjects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- LDL Cholesterol
研究概览
简要总结
The purpose of this study is to determine whether plant sterols esterified to fish oil fatty acids in a fish oil matrix improve the lipid profile, predominantly LDL-cholesterol and TG concentrations in healthy hyperlipidemic subjects.
详细描述
Phytosterols and omega-3 fatty acids (n-3) are natural food ingredients with potential cardiovascular (CVD) benefits. Phytosterols inhibit dietary cholesterol absorption and biliary cholesterol re-absorption, thereby reducing blood cholesterol levels, while consumption of n-3 is associated with a significant reduction in plasma triglyceride concentrations. Furthermore, n-3 may also beneficially modify a number of other risk factors of CHD, like anti-inflammatory and anti-thrombotic.
The primary objective of this study is to determine whether plant sterols esterified to fish oil fatty acids in a fish oil matrix improve the lipid profile, predominantly LDL-cholesterol and TG concentrations in healthy hyperlipidemic subjects. In addition the supplement efficacy to lower other CVD-related risk factors of healthy will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, >18 years old and ≤ 70 years old, capable and willing to give written informed consent.
- •Subject must have hyperlipidemia at the screening visit and at the end of the run-in period, defined as: fasting plasma triglycerides > 150 mg/dl and < 500 mg/dl, LDL-cholesterol > 130 mg/dl and < 190 mg/dl.
- •Fasting plasma glucose (FPG) levels at the screening visit < 110 mg/dl.
- •Female patient who is of reproductive potential agree to use acceptable methods of birth control
- •Female patient who is currently receiving hormone replacement therapy continuously 12 weeks before visit 1 (on stable dose) and will agree to do so during the study.
排除标准
- •Receiving medications or supplements known to affect lipid metabolism.
- •Uncontrolled hypertension or thyroid disease.
- •Consume unusual diets - will be determined at the discretion of the investigator.
- •Gained or lost more than 3 kg during the run-in period.
- •Patient has history of malignancy ≤ 5 years.
- •Patients with clinical ischemic CV disease on treatment
- •Consume 200 grams fish x 2 a week.
- •Gastrointestinal disease or any disease that the investigator feels would compromise the patient safety or limit his/her successful participation to the study.
- •Patient has type 1 or type 2 diabetes mellitus.
- •Patient has uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins
- •Patient has had active peptic ulcer disease within 3 months of visit
- •Woman patient is pregnant or breast-feeding or expecting to conceive during the study.
- •Patient has a history of hypersensitivity or allergy to fish, fish oil, corn oil or soy.
结局指标
主要结局
LDL Cholesterol
时间窗: at baseline
Average of blood test results at -10 and 0 days (before and after run-in period)
LDL-C
时间窗: 12 weeks
Blood test results following 12 weeks of intervention
次要结局
- Triglycerides(12 weeks)
- Total Cholesterol(12 weeks)
- HDL Cholesterol(at baseline)
- HDL-cholestrol(12 weeks)
- CRP(12 weeks)
- Apolipoprotein B100(12 weeks)
- Apolipoprotein A(12 weeks)