Acute Effects of Wine Consumption on Healthy Volunteers

NCT ID: NCT01627912

Last Updated: 2012-06-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2012-10-31

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.

Conditions

Healthy, Postprandial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Interventions

Robola, Cabernet Sauvignon wines

4 treatments on separate days: the subjects randomly consumed 4ml of drink \[white wine or red wine or 12.5% ethanol or water\]/kg of individual, parallel with a standardized meal.

Intervention Type: OTHER

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

• Minimum Eligible Age: 26 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Graduate Program of the Department of Nutrition and Dietetics

UNKNOWN

Sponsor Role: collaborator

Harokopio University

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Fragopoulou

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth Fragopoulou, Chemist PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Department of Nutrition-Dietetics, Harokopio University

Athens, , Greece

Countries

Greece

Other Identifiers

HUABIO01

Identifier Type: -

Identifier Source: org_study_id