NCT02609295已完成3 期
Effects of α-linolenic Acid Supplementation in the Form of Perilla Oil on Collagen-epinephrine Closure Time, Activated Partial Thromboplastin Time and Lp-PLA2 Activities in Nondiabetic and Hypercholesterolemic Subjects
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Collagen-Epinephrine Closure Time (C-EPI CT)
研究概览
简要总结
This study evaluates whether ALA intake alters total cholesterol and homeostatic factors and the relationship between these alteration and lipoprotein associated phospholipase A2 (Lp-PLA2) activity.
详细描述
An 8-week, randomized, double-blind, placebo-controlled study was conducted with 86 nondiabetic and borderline-to-moderate hypercholesterolemic (200mg/dL ≤ serum cholesterol ≤ 300mg/dL) subjects, not taking any medications and supplements to affect lipid metabolism, platelet function and inflammation, divided into two groups: an α-linolenic acid (ALA) group [1.2 g (two capsules) of perilla oil daily; 497 mg ALA] and a placebo group (1.2 g of medium-chain triglyceride oil daily).
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
- 40 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Voluntarily agree to participate and sign in informed consent form
- •Adults aged 40-70
- •Nondiabetic and hypercholesterolemic subjects (serum cholesterol ≥ 200 mg/dL)
排除标准
- •Subjects taking any medication or supplements known to affect lipid metabolism or platelet function, n-3 fatty acid supplementation or n-3 fatty acid-rich fish more than two times per week
- •Following diseases: dyslipidemia, hypertension, diabetes, liver disease, renal disease, pancreatitis, cardiovascular disease, gastrointestinal disease, cancer, or any other disease requiring treatment
- •Participation in clinical trials of any drug or supplement within 30 days prior to the participation of the study
- •Pregnant or lactating women, alcoholic, mental patient
- •Judged to be inappropriate for the study by the investigator after reviewing other reasons
结局指标
主要结局
Collagen-Epinephrine Closure Time (C-EPI CT)
时间窗: 8-week follow up
次要结局
- Fibrinogen(8-week follow up)
- Activated partial thromboplastin time (aPTT)(8-week follow up)
- Prothrombin Time (PT)(8-week follow up)
研究者
研究点 (2)
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