Study of the Anti-Inflammatory Health Benefits of "Argilos Extra Virgin Olive Oil" ("Healthy Argiloil")
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Effective Concentration of 50% of platelet aggregation (EC50 value) for PAF
研究概览
简要总结
This study aims to evaluate the in vivo antithrombotic and anti-inflammatory effects of extra virgin olive oil daily consumption at recommended doses for 1 month compared to similar consumption of classic table olive oil, in the blood plasma and platelets of healthy donors
详细描述
Introduction: Thrombo-inflammatory manifestations are key pathophysiological mechanisms of cardiovascular diseases and are directly related to platelet activation and aggregation. Extra virgin olive oil, a key component of the Mediterranean diet, is rich in natural bioactives (e.g. unsaturated fatty acids, polar lipids, phenolic compounds, carotenoids and other pigments), which have been proposed to possess not only antioxidant activities, but mainly strong anti-inflammatory and antiplatelet properties, which contribute to the reduction of cardiovascular risk. However, to our knowledge, nutritional and biochemical evaluation of these properties through an in vivo intervention study has not been thoroughly conducted, especially for the cardioprotective benefits of consuming such an extra virgin olive oil against the main thrombo-inflammatory pathways, and compared to plain classic table olive oil.
Purpose: The purpose of this study was the qualitative characterization of a sample of extra virgin olive oil and the biochemical investigation of the effect of its daily consumption on platelet activation and on the mechanisms related to thrombo-inflammation compared to the effects observed by a similar consumption of classic table olive oil.
Materials and Methods: An in vivo dietary intervention study, randomised and single blinded (the volunteers did not know what type of olive oil they consumed) was performed on four arms:
In the 1st arm, 18 healthy volunteers consumed the nutritionally recommended daily dose (30 mL) of extra virgin olive oil daily for 28 days.
In the 2nd arm, 18 other healthy volunteers consumed the nutritionally recommended daily dose (30 mL) of plain classic table olive oil daily for 28 days.
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
- Single (Participant)
盲法说明
Single blinded. The volunteers did not know what type of olive oil they were consuming during each period of the study, as the samples of olive oil were provided to them in similar bottles without any visionable differences
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Not to have a pathological condition related to platelet and leukocyte activity
- •Not to have a chronic pathological condition
- •To have a Normal Body Mass Index (BMI) and waist circumference
- •Not to take medications/supplements or any kind of other intervention that have anti-inflammatory and/or antithrombotic and/or antioxidant effects
排除标准
- •To have a pathological condition related to platelet and leukocyte activity
- •To have a chronic pathological condition
- •Not to have a Normal Body Mass Index (BMI) and waist circumference
- •To take medications/supplements/nutraceuticals or any kind of other intervention that have anti-inflammatory and/or antithrombotic and/or antioxidant effects
结局指标
主要结局
Effective Concentration of 50% of platelet aggregation (EC50 value) for PAF
时间窗: Blood sampling and platelet sensitization by PAF is assessed just before (day 0) and just after (day 28) of each intervention in platelets and plasma of blood samples from all volunteers in all these 4 arms
1\. The anti-inflammatory effects of the intervention assessed in platelets and plasma of blood samples from all volunteers are expressed as the Effective Concentrations that induce 50% of platelet aggregation (EC50 values) induced by platelet-activating factor (PAF), measured in nM concentration of PAF that can cause 50% of platelet aggregation.
Effective Concentration of 50% of platelet aggregation (EC50 value) for Thrombin
时间窗: Blood sampling and platelet sensitization by TRAP is assessed just before (day 0) and just after (day 28) of each intervention in platelets and plasma of blood samples from all volunteers in all these 4 arms
The antithrombotic effects of the intervention assessed in platelets and plasma of blood samples from all volunteers are expressed as the Effective Concentration that induce 50% of platelet aggregation (EC50 values) induced by the Thrombin Pathway, measured in μM concentration of Thrombin Receptor Active Peptide (TRAP) that can cause 50% of platelet aggregation
Effective Concentration of 50% of platelet aggregation (EC50 value) for ADP
时间窗: Blood sampling and platelet sensitization by ADP is assessed just before (day 0) and just after (day 28) of each intervention in platelets and plasma of blood samples from all volunteers in all these 4 arms
The antiplatelet effects of the intervention assessed in platelets and plasma of blood samples from all volunteers are expressed as the Effective Concentration that induce 50% of platelet aggregation (EC50 values) induced by the Adenosine 5' Diphosphate (ADP, measured in μM concentration of ADP that can cause 50% of platelet aggregation.
次要结局
未报告次要终点
研究者
Alexandros Tsoupras
Assistant Professor
Democritus University of Thrace