Antithrombotic Activities of a Novel Yogurt Drink: a Dietary Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Screening plasma levels of inflammatory markers.
研究概览
简要总结
This study aims to evaluate antithrombotic activities of novel yoghurt drink in healthy adult volunteers
详细描述
This randomized controlled, double-blinded crossover study aims to investigate the antithrombotic activities of a novel yoghurt drink in healthy adult volunteers. It is anticipated that the novel drink containing beneficial polar lipids will reduce platelet aggregation in participants and consequently decrease the onset of cardiovascular disease.
In Phase I, the subjects will provide blood samples after overnight fasting and then take either a yoghurt drink (YD) or placebo (that does not contain polar lipids) daily for 4 weeks. Following this period, they will again provide blood samples. Then, after a 2-week washout period in which the subjects do not take any yoghurt or placebo drink , Phase II of the clinical trial will commence. This is the crossover phase in which subjects who took YD will now be given a placebo drink, and vice versa, over 4 weeks. A total of 80 blood samples will be collected for analysis.
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
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults
排除标准
- •Volunteers need to be off medication and off any dietary supplements.
- •Subjects must not have any blood clotting disorders or dyslipidaemia.
- •Dairy intake needs to be within a normal range of 1-2 portions a week.
- •Unwilling to follow the study requirements.
结局指标
主要结局
Screening plasma levels of inflammatory markers.
时间窗: The outcomes of this testing will be assessed for up to roughly 6 months through study completion.
Platelet-rich plasma levels of the inflammatory markers (IL-6, CRP. TNF-α, VEGF, VCAM-1 and PAFR) will all be screened.
Screening plasma levels of triglycerides.
时间窗: The outcomes of this testing will be assessed for up to roughly 6 months through study completion.
PRP levels of triglycerides will also be screened.
Platelet aggregation of PRP samples in the presence of PAF
时间窗: Participants' platelet activity will be assessed for up to roughly 6 months through study completion
Platelet aggregation of participants' platelet-rich plasma samples (PRP) in the presence of the platelet agonist PAF will be assessed, using EC50 as a parameter.
Screening of plasma levels of cholesterol ( PL, LDL, HDL, VLDL).
时间窗: The outcomes of this testing will be assessed for up to roughly 6 months through study completion.
Platelet-rich plasma (PRP) levels of cholesterol ( PL, LDL, HDL, VLDL levels) will be assessed.
次要结局
未报告次要终点
研究者
Ioannis Zabetakis
Head of Department of Biological Sciences
University of Limerick