In Vitro And Ex Vivo Anti-Inflammatory Activities Of Salmon Polar Lipids
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Postprandial effect of Supplement/placebo on human platelet aggregation induced by Platelet Activating Factor (PAF)
研究概览
简要总结
The aim of this project is to study the effects of a new-developed food-supplement that contains bioactive polar lipids derived from organic farmed Irish salmon for the beneficial promotion of cardiovascular health. The health claims that will be formulated for this nutraceutical are based on EFSA guidelines "The scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health" and in particular paragraph 5.4, "Claims on reduced platelet aggregation" "Platelet hyperactivity and hypercoagulability states are more commonly observed in subjects with cardiovascular (CV) risk factors. Healthy subjects at very low risk of CV disease normally have non-activated circulating platelets. Decreasing platelet aggregation in subjects with platelet activation during sustained exposure to the food/constituent (e.g. four weeks) would be a beneficial physiological effect".
Within this study, the postprandial effects of this novel food supplement against platelet aggregation and inflammation are going to be exploited ex vivo in blood from human subjects as described in previously established procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
A placebo capsule (glycerine only, with no SPL)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects need to:
- •Have their dietary intake of fish to be within normal range (1-2 portions per week).
排除标准
- •Subjects will be excluded if they:
- •Are currently taking medication and/or dietary supplements
- •Have blood clotting disorders or dislipidemia
结局指标
主要结局
Postprandial effect of Supplement/placebo on human platelet aggregation induced by Platelet Activating Factor (PAF)
时间窗: 2 Months
Bio-assays on platelets will be assessed as previously described. Briefly: Standard PAF dissolved in BSA will have final concentrations 2.6e-8 - 2.6e-5 mol/L when testing into a Chronolog-490 two channel turbidimetric platelet aggregometer. The maximum reversible or the minimum irreversible PAF-induced platelet aggregation is determined as the 100% aggregation, and then various PAF concentrations are added, so as to achieve aggregations between 20% and 80% aggregation, which are of linear response to the added PAF concentration. The EC50 value that accounts for the PAF concentration (mol/L) inducing 50% aggregation of human platelets will be calculated by the equation derived from this linear curve. Results will be expressed as percentage change of EC50 on 1, 2, 3 and 4 hours of the food supplement/placebo administration, compared with baseline (0 hours)
次要结局
- Postprandial effect of Supplement/placebo on human platelet aggregation induced by Thrombin(2 Months)
研究者
Ioannis Zabetakis
Principal Investigator
University of Limerick