Acute Effects of Wine Consumption on Healthy Volunteers (winepost)

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

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.

Study Overview

• Status: Unknown
• Conditions: Healthy, Postprandial
• Intervention / Treatment: Other: Robola, Cabernet Sauvignon wines

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 17671
    • Department of Nutrition-Dietetics, Harokopio University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 39 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
platelet aggregation	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.	baseline
platelet aggregation	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.	30 min after standardized meal plus tested drink consumption.
platelet aggregation	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.	90 min after standardized meal plus tested drink consumption.
platelet aggregation	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.	150 min after standardized meal plus tested drink consumption
platelet aggregation	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.	210 min after standardized meal plus tested drink consumption.
platelet aggregation	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.	300 min after standardized meal plus tested drink consumption.
markers of inflammation		baseline
markers of inflammation		0 min after standardized meal plus tested drink consumption
markers of inflammation		30 min after standardized meal plus tested drink consumption
markers of inflammation		60 min after standardized meal plus tested drink consumption
markers of inflammation		90 min after standardized meal plus tested drink consumption
markers of inflammation		120 min after standardized meal plus tested drink consumption
markers of inflammation		150 min after standardized meal plus tested drink consumption
markers of inflammation		180 min after standardized meal plus tested drink consumption
markers of inflammation		210 min after standardized meal plus tested drink consumption
markers of inflammation		240 min after standardized meal plus tested drink consumption
markers of inflammation		300 min after standardized meal plus tested drink consumption
markers of inflammation		360 min after standardized meal plus tested drink consumption
markers of oxidative stress	TBARS, ex vivo serum oxidation etc	baseline
markers of oxidative stress	TBARS, ex vivo serum oxidation etc	0 min after standardized meal plus tested drink consumption
markers of oxidative stress	TBARS, ex vivo serum oxidation etc	30 min after standardized meal plus tested drink consumption
markers of oxidative stress	TBARS, ex vivo serum oxidation etc	60 min after standardized meal plus tested drink consumption
markers of oxidative stress	TBARS, ex vivo serum oxidation etc	90 min after standardized meal plus tested drink consumption
markers of oxidative stress	TBARS, ex vivo serum oxidation etc	120 min after standardized meal plus tested drink consumption
markers of oxidative stress	TBARS, ex vivo serum oxidation etc	150 min after standardized meal plus tested drink consumption
markers of oxidative stress	TBARS, ex vivo serum oxidation etc	180 min after standardized meal plus tested drink consumption
markers of oxidative stress	TBARS, ex vivo serum oxidation etc	210 min after standardized meal plus tested drink consumption
markers of oxidative stress	TBARS, ex vivo serum oxidation etc	240 min after standardized meal plus tested drink consumption
markers of oxidative stress	TBARS, ex vivo serum oxidation etc	300 min after standardized meal plus tested drink consumption
markers of oxidative stress	TBARS, ex vivo serum oxidation etc	360 min after standardized meal plus tested drink consumption
PAF metabolism	Measurement of PAF biosynthetic / catabolic enzymes in leucocytes and LpPLA2 in serum	0 min after standardized meal plus tested drink consumption
PAF metabolism	Measurement of PAF biosynthetic / catabolic enzymes in leucocytes and LpPLA2 in serum	60 min after standardized meal plus tested drink consumption
PAF metabolism	Measurement of PAF biosynthetic / catabolic enzymes in leucocytes and LpPLA2 in serum	90 min after standardized meal plus tested drink consumption
PAF metabolism	Measurement of PAF biosynthetic / catabolic enzymes in leucocytes and LpPLA2 in serum	120 min after standardized meal plus tested drink consumption
PAF metabolism	Measurement of PAF biosynthetic / catabolic enzymes in leucocytes and LpPLA2 in serum	180 min after standardized meal plus tested drink consumption
PAF metabolism	Measurement of PAF biosynthetic / catabolic enzymes in leucocytes and LpPLA2 in serum	210 min after standardized meal plus tested drink consumption
PAF metabolism	Measurement of PAF biosynthetic / catabolic enzymes in leucocytes and LpPLA2 in serum	240 min after standardized meal plus tested drink consumption
PAF metabolism	Measurement of PAF biosynthetic / catabolic enzymes in leucocytes and LpPLA2 in serum	300 min after standardized meal plus tested drink consumption
PAF metabolism	Measurement of PAF biosynthetic / catabolic enzymes in leucocytes and LpPLA2 in serum	360 min after standardized meal plus tested drink consumption

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose levels		baseline
Glucose levels		0 min after standardized meal plus tested drink consumption
Glucose levels		30 min after standardized meal plus tested drink consumption
Glucose levels		60 min after standardized meal plus tested drink consumption
Glucose levels		90 min after standardized meal plus tested drink consumption
Glucose levels		120 min after standardized meal plus tested drink consumption
Glucose levels		150 min after standardized meal plus tested drink consumption
Glucose levels		180 min after standardized meal plus tested drink consumption
Glucose levels		210 min after standardized meal plus tested drink consumption
Glucose levels		240 min after standardized meal plus tested drink consumption
Glucose levels		300 min after standardized meal plus tested drink consumption
Glucose levels		360 min after standardized meal plus tested drink consumption
Insulin levels		0 min after standardized meal plus tested drink consumption
Insulin levels		30 min after standardized meal plus tested drink consumption
Insulin levels		60 min after standardized meal plus tested drink consumption
Insulin levels		90 min after standardized meal plus tested drink consumption
Insulin levels		120 min after standardized meal plus tested drink consumption
lipids	HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides	baseline
lipids	HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides	0 min after standardized meal plus tested drink consumption
lipids	HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides	30 min after standardized meal plus tested drink consumption
lipids	HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides	60 min after standardized meal plus tested drink consumption
lipids	HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides	90 min after standardized meal plus tested drink consumption
lipids	HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides	120 min after standardized meal plus tested drink consumption
lipids	HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides	150 min after standardized meal plus tested drink consumption
lipids	HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides	180 min after standardized meal plus tested drink consumption
lipids	HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides	210 min after standardized meal plus tested drink consumption
lipids	HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides	240 min after standardized meal plus tested drink consumption
lipids	HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides	300 min after standardized meal plus tested drink consumption
lipids	HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides	360 min after standardized meal plus tested drink consumption

Collaborators and Investigators

• Sponsor: Harokopio University
• Collaborators: Graduate Program of the Department of Nutrition and Dietetics
• Investigators: Principal Investigator: Elizabeth Fragopoulou, Chemist PhD, Department of Nutrition-Dietetics, Harokopio University, Athens, Greece

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Anticipated): October 1, 2012

Study Registration Dates

• First Submitted: June 14, 2012
• First Submitted That Met QC Criteria: June 22, 2012
• First Posted (Estimate): June 26, 2012

Study Record Updates

• Last Update Posted (Estimate): June 26, 2012
• Last Update Submitted That Met QC Criteria: June 22, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: platelet aggregation; haemostasis; alcohol; inflammation; oxidative stress; randomized control trial; wine; postprandial intervention; robola; cabernet sauvignon; PAF metabolism
• Other Study ID Numbers: HUABIO01