Overview

This trial is active, not recruiting.

Condition healthy, postprandial
Treatment robola, cabernet sauvignon wines
Sponsor Harokopio University
Collaborator Graduate Program of the Department of Nutrition and Dietetics
Start date April 2011
End date October 2011
Trial size 10 participants
Trial identifier NCT01627912, HUABIO01

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking single blind (subject)
Primary purpose prevention

Primary Outcomes

Measure
platelet aggregation
time frame: baseline
platelet aggregation
time frame: 30 min after standardized meal plus tested drink consumption.
platelet aggregation
time frame: 90 min after standardized meal plus tested drink consumption.
platelet aggregation
time frame: 150 min after standardized meal plus tested drink consumption
platelet aggregation
time frame: 210 min after standardized meal plus tested drink consumption.
platelet aggregation
time frame: 300 min after standardized meal plus tested drink consumption.
markers of inflammation
time frame: baseline
markers of inflammation
time frame: 0 min after standardized meal plus tested drink consumption
markers of inflammation
time frame: 30 min after standardized meal plus tested drink consumption
markers of inflammation
time frame: 60 min after standardized meal plus tested drink consumption
markers of inflammation
time frame: 90 min after standardized meal plus tested drink consumption
markers of inflammation
time frame: 120 min after standardized meal plus tested drink consumption
markers of inflammation
time frame: 150 min after standardized meal plus tested drink consumption
markers of inflammation
time frame: 180 min after standardized meal plus tested drink consumption
markers of inflammation
time frame: 210 min after standardized meal plus tested drink consumption
markers of inflammation
time frame: 240 min after standardized meal plus tested drink consumption
markers of inflammation
time frame: 300 min after standardized meal plus tested drink consumption
markers of inflammation
time frame: 360 min after standardized meal plus tested drink consumption
markers of oxidative stress
time frame: baseline
markers of oxidative stress
time frame: 0 min after standardized meal plus tested drink consumption
markers of oxidative stress
time frame: 30 min after standardized meal plus tested drink consumption
markers of oxidative stress
time frame: 60 min after standardized meal plus tested drink consumption
markers of oxidative stress
time frame: 90 min after standardized meal plus tested drink consumption
markers of oxidative stress
time frame: 120 min after standardized meal plus tested drink consumption
markers of oxidative stress
time frame: 150 min after standardized meal plus tested drink consumption
markers of oxidative stress
time frame: 180 min after standardized meal plus tested drink consumption
markers of oxidative stress
time frame: 210 min after standardized meal plus tested drink consumption
markers of oxidative stress
time frame: 240 min after standardized meal plus tested drink consumption
markers of oxidative stress
time frame: 300 min after standardized meal plus tested drink consumption
markers of oxidative stress
time frame: 360 min after standardized meal plus tested drink consumption
PAF metabolism
time frame: 0 min after standardized meal plus tested drink consumption
PAF metabolism
time frame: 60 min after standardized meal plus tested drink consumption
PAF metabolism
time frame: 90 min after standardized meal plus tested drink consumption
PAF metabolism
time frame: 120 min after standardized meal plus tested drink consumption
PAF metabolism
time frame: 180 min after standardized meal plus tested drink consumption
PAF metabolism
time frame: 210 min after standardized meal plus tested drink consumption
PAF metabolism
time frame: 240 min after standardized meal plus tested drink consumption
PAF metabolism
time frame: 300 min after standardized meal plus tested drink consumption
PAF metabolism
time frame: 360 min after standardized meal plus tested drink consumption

Secondary Outcomes

Measure
Glucose levels
time frame: baseline
Glucose levels
time frame: 0 min after standardized meal plus tested drink consumption
Glucose levels
time frame: 30 min after standardized meal plus tested drink consumption
Glucose levels
time frame: 60 min after standardized meal plus tested drink consumption
Glucose levels
time frame: 90 min after standardized meal plus tested drink consumption
Glucose levels
time frame: 120 min after standardized meal plus tested drink consumption
Glucose levels
time frame: 150 min after standardized meal plus tested drink consumption
Glucose levels
time frame: 180 min after standardized meal plus tested drink consumption
Glucose levels
time frame: 210 min after standardized meal plus tested drink consumption
Glucose levels
time frame: 240 min after standardized meal plus tested drink consumption
Glucose levels
time frame: 300 min after standardized meal plus tested drink consumption
Glucose levels
time frame: 360 min after standardized meal plus tested drink consumption
Insulin levels
time frame: 0 min after standardized meal plus tested drink consumption
Insulin levels
time frame: 30 min after standardized meal plus tested drink consumption
Insulin levels
time frame: 60 min after standardized meal plus tested drink consumption
Insulin levels
time frame: 90 min after standardized meal plus tested drink consumption
Insulin levels
time frame: 120 min after standardized meal plus tested drink consumption
lipids
time frame: baseline
lipids
time frame: 0 min after standardized meal plus tested drink consumption
lipids
time frame: 30 min after standardized meal plus tested drink consumption
lipids
time frame: 60 min after standardized meal plus tested drink consumption
lipids
time frame: 90 min after standardized meal plus tested drink consumption
lipids
time frame: 120 min after standardized meal plus tested drink consumption
lipids
time frame: 150 min after standardized meal plus tested drink consumption
lipids
time frame: 180 min after standardized meal plus tested drink consumption
lipids
time frame: 210 min after standardized meal plus tested drink consumption
lipids
time frame: 240 min after standardized meal plus tested drink consumption
lipids
time frame: 300 min after standardized meal plus tested drink consumption
lipids
time frame: 360 min after standardized meal plus tested drink consumption

Eligibility Criteria

Male participants from 26 years up to 39 years old.

Inclusion Criteria: - healthy - non-obese Exclusion Criteria: - smokers - those who reported slimming or any other dietary regime - abstainers from alcohol consumption - heavy drinkers - athletes - 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

Additional Information

Official title Acute Effects of Wine Consumption on Platelet Aggregation, and on Inflammatory / Oxidative Stress Markers
Principal investigator Elizabeth Fragopoulou, Chemist PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2012.
Information provided to ClinicalTrials.gov by Harokopio University.