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临床试验/NCT01627912
NCT01627912Unknown不适用

Acute Effects of Wine Consumption on Platelet Aggregation, and on Inflammatory / Oxidative Stress Markers

Harokopio University2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2011年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
10
试验地点
2
主要终点
platelet aggregation

研究概览

简要总结

The purpose of this study is to investigate whether red and white wine consumption has acute effects on postprandial biochemical markers related to platelet aggregation, inflammation and oxidative stress compared to water or 12.5% ethanol aqueous solution consumption.

详细描述

The last few years, epidemiologic studies indicate that regular moderate consumption of alcohol is associated with lower risk of coronary heart disease and heart attack, as well as with lower mortality. More specific, a J or U-shaped association between alcohol consumption and the incidence of coronary heart disease have been suggested, which means that there was lower disease risk in moderate alcohol consumers than in abstainers or heavy drinkers.

The scientific interest was focused on wine after the term "French paradox" was introduced, in order to describe the epidemiological observation that the French suffer a relatively low incidence of coronary heart disease, despite having a diet relatively rich in saturated fats. The paradox was attributed to the moderate consumption of red wine by French. Even though many clinical studies have occurred since then, only few of them report the postprandial effect of wine, mainly focusing on the study of oxidative stress markers and endothelium dysfunction. Also, a limited number of publications refer to the postprandial wine effect upon platelet aggregation, which is an indicative marker for inflammation / thrombosis and atherosclerosis.

The limited clinical evidence prompted us to investigate the postprandial effect of wine consumption upon platelet aggregation, inflammation and oxidation markers, by undertaking a clinical study of crossover design. The subjects randomly consumed 4ml of drink [Robola or Cabernet Sauvignon or 12.5% ethanol or water]/kg of individual, parallel with a standardized meal, which consisted of 30.8% carbohydrates, 12.0% proteins and 53.1% fat. The meal total energy was 787.2 kcal.

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)

入排标准

年龄范围
26 Years 至 39 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • non-obese

排除标准

  • those who reported slimming or any other dietary regime
  • abstainers from alcohol consumption
  • heavy drinkers
  • subjects who were on medication, such as aspirin, that may have an impact on platelet aggregation or surgical events that may have affected the study outcomes
  • participants with a known diagnosis of either hypertension or diabetes
  • subjects on medication

结局指标

主要结局

platelet aggregation

时间窗: 300 min after standardized meal plus tested drink consumption.

In each time point platelet rich plasma (PRP) was isolated from the blood of volunteers and platelet aggregation upon Platelet activating factor (PAF) was measured in CHRONO-LOG aggregometer.

markers of inflammation

时间窗: 360 min after standardized meal plus tested drink consumption

markers of oxidative stress

时间窗: 360 min after standardized meal plus tested drink consumption

TBARS, ex vivo serum oxidation etc

PAF metabolism

时间窗: 360 min after standardized meal plus tested drink consumption

Measurement of PAF biosynthetic / catabolic enzymes in leucocytes and LpPLA2 in serum

次要结局

  • Glucose levels(360 min after standardized meal plus tested drink consumption)
  • Insulin levels(120 min after standardized meal plus tested drink consumption)
  • lipids(360 min after standardized meal plus tested drink consumption)

研究者

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

Elizabeth Fragopoulou

PhD

Harokopio University

研究点 (2)

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