Clinical trial NCT01627912: Acute Effects of Wine Consumption on Healthy Volunteers
Official title: Acute Effects of Wine Consumption on Platelet Aggregation, and on Inflammatory / Oxidative Stress Markers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy, Postprandial
Keywords: wine
inflammation
oxidative stress
randomized control trial
postprandial intervention
platelet aggregation
haemostasis
robola
cabernet sauvignon
alcohol
PAF metabolism
Lead sponsor: Harokopio University
Sponsor class: OTHER
Collaborators: name: Graduate Program of the Department of Nutrition and Dietetics
First posted: 2012-06-26
Enrollment: 10
Sex: MALE
Minimum age (years): 26
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: platelet aggregation
timeFrame: baseline
measure: platelet aggregation
timeFrame: 30 min after standardized meal plus tested drink consumption.
measure: platelet aggregation
timeFrame: 90 min after standardized meal plus tested drink consumption.
measure: platelet aggregation
timeFrame: 150 min after standardized meal plus tested drink consumption
measure: platelet aggregation
timeFrame: 210 min after standardized meal plus tested drink consumption.
measure: platelet aggregation
timeFrame: 300 min after standardized meal plus tested drink consumption.
measure: markers of inflammation
timeFrame: baseline
measure: markers of inflammation
timeFrame: 0 min after standardized meal plus tested drink consumption
measure: markers of inflammation
timeFrame: 30 min after standardized meal plus tested drink consumption
measure: markers of inflammation
timeFrame: 60 min after standardized meal plus tested drink consumption
measure: markers of inflammation
timeFrame: 90 min after standardized meal plus tested drink consumption
measure: markers of inflammation
timeFrame: 120 min after standardized meal plus tested drink consumption
measure: markers of inflammation
timeFrame: 150 min after standardized meal plus tested drink consumption
measure: markers of inflammation
timeFrame: 180 min after standardized meal plus tested drink consumption
measure: markers of inflammation
timeFrame: 210 min after standardized meal plus tested drink consumption
measure: markers of inflammation
timeFrame: 240 min after standardized meal plus tested drink consumption
measure: markers of inflammation
timeFrame: 300 min after standardized meal plus tested drink consumption
measure: markers of inflammation
timeFrame: 360 min after standardized meal plus tested drink consumption
measure: markers of oxidative stress
timeFrame: baseline
measure: markers of oxidative stress
timeFrame: 0 min after standardized meal plus tested drink consumption
measure: markers of oxidative stress
timeFrame: 30 min after standardized meal plus tested drink consumption
measure: markers of oxidative stress
timeFrame: 60 min after standardized meal plus tested drink consumption
measure: markers of oxidative stress
timeFrame: 90 min after standardized meal plus tested drink consumption
measure: markers of oxidative stress
timeFrame: 120 min after standardized meal plus tested drink consumption
measure: markers of oxidative stress
timeFrame: 150 min after standardized meal plus tested drink consumption
measure: markers of oxidative stress
timeFrame: 180 min after standardized meal plus tested drink consumption
measure: markers of oxidative stress
timeFrame: 210 min after standardized meal plus tested drink consumption
measure: markers of oxidative stress
timeFrame: 240 min after standardized meal plus tested drink consumption
measure: markers of oxidative stress
timeFrame: 300 min after standardized meal plus tested drink consumption
measure: markers of oxidative stress
timeFrame: 360 min after standardized meal plus tested drink consumption
measure: PAF metabolism
timeFrame: 0 min after standardized meal plus tested drink consumption
measure: PAF metabolism
timeFrame: 60 min after standardized meal plus tested drink consumption
measure: PAF metabolism
timeFrame: 90 min after standardized meal plus tested drink consumption
measure: PAF metabolism
timeFrame: 120 min after standardized meal plus tested drink consumption
measure: PAF metabolism
timeFrame: 180 min after standardized meal plus tested drink consumption
measure: PAF metabolism
timeFrame: 210 min after standardized meal plus tested drink consumption
measure: PAF metabolism
timeFrame: 240 min after standardized meal plus tested drink consumption
measure: PAF metabolism
timeFrame: 300 min after standardized meal plus tested drink consumption
measure: PAF metabolism
timeFrame: 360 min after standardized meal plus tested drink consumption
Secondary outcomes:
measure: Glucose levels
timeFrame: baseline
measure: Glucose levels
timeFrame: 0 min after standardized meal plus tested drink consumption
measure: Glucose levels
timeFrame: 30 min after standardized meal plus tested drink consumption
measure: Glucose levels
timeFrame: 60 min after standardized meal plus tested drink consumption
measure: Glucose levels
timeFrame: 90 min after standardized meal plus tested drink consumption
measure: Glucose levels
timeFrame: 120 min after standardized meal plus tested drink consumption
measure: Glucose levels
timeFrame: 150 min after standardized meal plus tested drink consumption
measure: Glucose levels
timeFrame: 180 min after standardized meal plus tested drink consumption
measure: Glucose levels
timeFrame: 210 min after standardized meal plus tested drink consumption
measure: Glucose levels
timeFrame: 240 min after standardized meal plus tested drink consumption
measure: Glucose levels
timeFrame: 300 min after standardized meal plus tested drink consumption
measure: Glucose levels
timeFrame: 360 min after standardized meal plus tested drink consumption
measure: Insulin levels
timeFrame: 0 min after standardized meal plus tested drink consumption
measure: Insulin levels
timeFrame: 30 min after standardized meal plus tested drink consumption
measure: Insulin levels
timeFrame: 60 min after standardized meal plus tested drink consumption
measure: Insulin levels
timeFrame: 90 min after standardized meal plus tested drink consumption
measure: Insulin levels
timeFrame: 120 min after standardized meal plus tested drink consumption
measure: lipids
timeFrame: baseline
measure: lipids
timeFrame: 0 min after standardized meal plus tested drink consumption
measure: lipids
timeFrame: 30 min after standardized meal plus tested drink consumption
measure: lipids
timeFrame: 60 min after standardized meal plus tested drink consumption
measure: lipids
timeFrame: 90 min after standardized meal plus tested drink consumption
measure: lipids
timeFrame: 120 min after standardized meal plus tested drink consumption
measure: lipids
timeFrame: 150 min after standardized meal plus tested drink consumption
measure: lipids
timeFrame: 180 min after standardized meal plus tested drink consumption
measure: lipids
timeFrame: 210 min after standardized meal plus tested drink consumption
measure: lipids
timeFrame: 240 min after standardized meal plus tested drink consumption
measure: lipids
timeFrame: 300 min after standardized meal plus tested drink consumption
measure: lipids
timeFrame: 360 min after standardized meal plus tested drink consumption
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Department of Nutrition-Dietetics, Harokopio University
Study officials:
affiliation: Department of Nutrition-Dietetics, Harokopio University, Athens, Greece
name: Elizabeth Fragopoulou, Chemist PhD
role: PRINCIPAL_INVESTIGATOR
References: