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临床试验/NCT05290883
NCT05290883已完成不适用

Antithrombotic Activities of a Novel Yoghurt Drink: a Postprandial Study

University of Limerick2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2021年5月14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
5
试验地点
2
主要终点
An investigation of anti-platelet or antithrombotic effect of novel yoghurt drink by platelet aggregometry

研究概览

简要总结

The project aims to investigate the antithrombotic activity of the novel yoghurt drink enriched with polar lipids derived from ovine milk. The health claims the formulated novel or functional food on EFSA guidelines "The scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health" and in a 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 or participants at very low risk of CV disease normally have non-activated circulating platelets. Reducing 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 investigation, the postprandial effects of this novel yoghurt drink against platelet aggregation are going to be studied ex vivo in blood from healthy human subjects as described in previously established procedures.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • • Healthy subjects need to have their dietary and dairy intake within the range [1-2 serves per week]

排除标准

  • Subjects will be excluded from the study if they are
  • Under medication and intake of dietary supplements
  • Treatment for blood clotting disorders or dyslipidaemia

结局指标

主要结局

An investigation of anti-platelet or antithrombotic effect of novel yoghurt drink by platelet aggregometry

时间窗: 0 mins (preprandially) to 240 mins (postprandially)

An investigation of anti-platelet or antithrombotic effect of novel yoghurt drink by platelet aggregometry will be carried out. The postprandial effect of novel yoghurt drink will be studied by using a platelet aggregation method as per literature. The antithrombotic effect of yoghurt drink lipids will be studied, using PAF and TRAP as platelet aggregation mediators. The investigation will be based on the study-specific platelet aggregometry analysis. Subjects will come to the lab after overnight fasting and they will be provided yoghurt drink (200mL); the activation of their platelets will be monitored over a period of 4 hours (0 to 4 hours study with 1 hour check points).

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

Senior Lecturer

University of Limerick

研究点 (2)

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