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临床试验/NCT03866265
NCT03866265已完成不适用

Anti-Inflammatory and Anti-Coagulant Effects of a Novel Food Grade Salmon Polar Lipids Supplement

University of Limerick2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Effect on the Platelet Sensitivity against PAF

研究概览

简要总结

Inflammation is a normal immune response to tissue healing. However, uncontrolled and unresolved inflammation can initiate and further induce several chronic manifestations that contribute to chronic disorders such as atherosclerosis and cardiovascular disease (CVD). A 'cross-talk' between platelets, endothelial cells and leukocytes, accompanied by activation and aggregation of platelets, contribute to inflammation-related atherogenic, atherosclerotic and athero-thrombotic events.

Platelet Activating Factor (PAF) and Thrombin are the most potent platelet agonists inducing platelet activation and aggregation that are also implicated in the patho-physiology of platelets and endothelium and thus in inflammation-related chronic disorders. Therefore, the inhibition of PAF and Thrombin related pathways of platelet aggregation, coagulation and inflammation provide a potential therapeutic strategy for anti-platelet, anti-coagulation and suppression of inflammatory responses in CVDs and other chronic disorders.

The investigators have previously reported bio-active lipid molecules with strong anti-PAF and anti-Thrombin effects to be present in natural, non-toxic food, microorganisms, plants and especially in several marine sources. The plethora of in vitro beneficial bio-activities of marine polar lipids (PLs) against atherosclerosis and CVDs indicate therapeutic potential. Recently, the investigators have also demonstrated that PLs extracted from Irish, organic farmed salmon (Salmo salar) display strong in vitro anti-thrombotic effects against platelet aggregation, bio-activities that were related to inhibitory effect against PAF and Thrombin pathways.

The present study investigates the putative anti-platelet effects in healthy human subjects following ingestion of a novel supplement containing food-grade extracts of bio-active salmon polar lipids (FGE-Salmon-PLs).

The study has a double blind randomized cross-over placebo-controlled design in healthy subjects.

Each Subject will be administrated the FGE-Salmon-PLs Food Supplement capsules for 28 days (a capsule containing 0.125 g of FGE-Salmon-PLs per day) and platelet sensitivity against both PAF and Thrombin will be tested in blood samples of each subject just before and after the supplement administration. The same tests will be conducted in blood samples of each participant in a crossover design before and after 28 days of placebo capsules administration (a capsule containing 0.125 g of glycerin per day).

详细描述

The present study investigates the putative anti-platelet effects in healthy human subjects (N=20) following ingestion of a novel supplement containing food-grade extracts of bio-active salmon polar lipids (FGE-Salmon-PLs).

The study has a double blind randomized cross-over placebo-controlled design in healthy subjects.

After appropriate screening, 20 of the recruited subjects will provide baseline blood samples and then 10 of them will be initially administered a food supplement capsule (containing 0.125 g of FGE-Salmon-PLs) per day for a period of 28 days, while another 10 of them will initially be administered a placebo capsule (containing 0.125 g of glycerin) per day, in a double blind and randomized way.

After the period of 28 days, each participant will provide blood samples at the 29th day.

Then a washout period of 14 days will follow, in which each participant will not be administered any kind of supplements or placebo capsules.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • The selection criteria of the subjects will be as follows:
  • they need to be off medication and off intake of dietary supplements
  • they need to have no blood clotting disorders or dyslipidaemia and

排除标准

  • Subjects with clotting disorders, dyslipidemia or being on medication (i.e. statins) or other supplements during the study will be excluded.

结局指标

主要结局

Effect on the Platelet Sensitivity against PAF

时间窗: Tests will be conducted just after blood collection for each blood sample and the outcomes measured will be assessed up to 6 months, for which the data will be reported through study completion

Platelet sensitivity against PAF of platelet rich plasma of each blood sample will be determined by the % observed change of the EC50 value of PAF-induced platelet aggregation before and after administration of either the FGE-Salmon-PLs food supplement or the placebo capsules.

Effect on the Platelet Sensitivity against Thrombin

时间窗: Tests will be conducted just after blood collection for each blood sample and the outcomes measured will be assessed up to 6 months, for which the data will be reported through study completion

Platelet sensitivity against Thrombin of platelet rich plasma of each blood sample will be determined by the % observed change of the EC50 value of Thrombin-induced platelet aggregation before and after administration of either the FGE-Salmon-PLs food supplement or the placebo capsules.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ioannis Zabetakis

Head of the Department of Biological Sciences

University of Limerick

研究点 (2)

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