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Acute Effects of Wine Consumption on Healthy Volunteers (winepost)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Graduate Program of the Department of Nutrition and Dietetics
Information provided by (Responsible Party):
Elizabeth Fragopoulou, Harokopio University
ClinicalTrials.gov Identifier:
NCT01627912
First received: June 14, 2012
Last updated: June 22, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Healthy, Postprandial
 Other: Robola, Cabernet Sauvignon wines

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Acute Effects of Wine Consumption on Platelet Aggregation, and on Inflammatory / Oxidative Stress Markers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Harokopio University:

Primary Outcome Measures:
  • platelet aggregation [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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.

  • platelet aggregation [ Time Frame: 30 min after standardized meal plus tested drink consumption. ] [ Designated as safety issue: No ]
    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.

  • platelet aggregation [ Time Frame: 90 min after standardized meal plus tested drink consumption. ] [ Designated as safety issue: No ]
    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.

  • platelet aggregation [ Time Frame: 150 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
    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.

  • platelet aggregation [ Time Frame: 210 min after standardized meal plus tested drink consumption. ] [ Designated as safety issue: No ]
    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.

  • platelet aggregation [ Time Frame: 300 min after standardized meal plus tested drink consumption. ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • markers of inflammation [ Time Frame: 0 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
  • markers of inflammation [ Time Frame: 30 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
  • markers of inflammation [ Time Frame: 60 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
  • markers of inflammation [ Time Frame: 90 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
  • markers of inflammation [ Time Frame: 120 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
  • markers of inflammation [ Time Frame: 150 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
  • markers of inflammation [ Time Frame: 180 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
  • markers of inflammation [ Time Frame: 210 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
  • markers of inflammation [ Time Frame: 240 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
  • markers of inflammation [ Time Frame: 300 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
  • markers of inflammation [ Time Frame: 360 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
  • markers of oxidative stress [ Time Frame: baseline ] [ Designated as safety issue: No ]
    TBARS, ex vivo serum oxidation etc

  • markers of oxidative stress [ Time Frame: 0 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
    TBARS, ex vivo serum oxidation etc

  • markers of oxidative stress [ Time Frame: 30 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
    TBARS, ex vivo serum oxidation etc

  • markers of oxidative stress [ Time Frame: 60 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
    TBARS, ex vivo serum oxidation etc

  • markers of oxidative stress [ Time Frame: 90 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
    TBARS, ex vivo serum oxidation etc

  • markers of oxidative stress [ Time Frame: 120 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
    TBARS, ex vivo serum oxidation etc

  • markers of oxidative stress [ Time Frame: 150 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
    TBARS, ex vivo serum oxidation etc

  • markers of oxidative stress [ Time Frame: 180 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
    TBARS, ex vivo serum oxidation etc

  • markers of oxidative stress [ Time Frame: 210 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
    TBARS, ex vivo serum oxidation etc

  • markers of oxidative stress [ Time Frame: 240 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
    TBARS, ex vivo serum oxidation etc

  • markers of oxidative stress [ Time Frame: 300 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
    TBARS, ex vivo serum oxidation etc

  • markers of oxidative stress [ Time Frame: 360 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
    TBARS, ex vivo serum oxidation etc

  • PAF metabolism [ Time Frame: 0 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
    Measurement of PAF biosynthetic / catabolic enzymes in leucocytes and LpPLA2 in serum

  • PAF metabolism [ Time Frame: 60 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
    Measurement of PAF biosynthetic / catabolic enzymes in leucocytes and LpPLA2 in serum

  • PAF metabolism [ Time Frame: 90 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
    Measurement of PAF biosynthetic / catabolic enzymes in leucocytes and LpPLA2 in serum

  • PAF metabolism [ Time Frame: 120 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
    Measurement of PAF biosynthetic / catabolic enzymes in leucocytes and LpPLA2 in serum

  • PAF metabolism [ Time Frame: 180 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
    Measurement of PAF biosynthetic / catabolic enzymes in leucocytes and LpPLA2 in serum

  • PAF metabolism [ Time Frame: 210 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
    Measurement of PAF biosynthetic / catabolic enzymes in leucocytes and LpPLA2 in serum

  • PAF metabolism [ Time Frame: 240 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
    Measurement of PAF biosynthetic / catabolic enzymes in leucocytes and LpPLA2 in serum

  • PAF metabolism [ Time Frame: 300 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
    Measurement of PAF biosynthetic / catabolic enzymes in leucocytes and LpPLA2 in serum

  • PAF metabolism [ Time Frame: 360 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
    Measurement of PAF biosynthetic / catabolic enzymes in leucocytes and LpPLA2 in serum


Secondary Outcome Measures:
  • Glucose levels [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Glucose levels [ Time Frame: 0 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
  • Glucose levels [ Time Frame: 30 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
  • Glucose levels [ Time Frame: 60 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
  • Glucose levels [ Time Frame: 90 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
  • Glucose levels [ Time Frame: 120 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
  • Glucose levels [ Time Frame: 150 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
  • Glucose levels [ Time Frame: 180 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
  • Glucose levels [ Time Frame: 210 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
  • Glucose levels [ Time Frame: 240 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
  • Glucose levels [ Time Frame: 300 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
  • Glucose levels [ Time Frame: 360 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
  • Insulin levels [ Time Frame: 0 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
  • Insulin levels [ Time Frame: 30 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
  • Insulin levels [ Time Frame: 60 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
  • Insulin levels [ Time Frame: 90 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
  • Insulin levels [ Time Frame: 120 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
  • lipids [ Time Frame: baseline ] [ Designated as safety issue: No ]
    HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides

  • lipids [ Time Frame: 0 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
    HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides

  • lipids [ Time Frame: 30 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
    HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides

  • lipids [ Time Frame: 60 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
    HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides

  • lipids [ Time Frame: 90 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
    HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides

  • lipids [ Time Frame: 120 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
    HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides

  • lipids [ Time Frame: 150 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
    HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides

  • lipids [ Time Frame: 180 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
    HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides

  • lipids [ Time Frame: 210 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
    HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides

  • lipids [ Time Frame: 240 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
    HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides

  • lipids [ Time Frame: 300 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
    HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides

  • lipids [ Time Frame: 360 min after standardized meal plus tested drink consumption ] [ Designated as safety issue: No ]
    HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides


Enrollment: 10
Study Start Date: April 2011
Estimated Study Completion Date: October 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: 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.
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

Ages Eligible for Study:   26 Years to 39 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01627912

Locations
Greece
Department of Nutrition-Dietetics, Harokopio University
Athens, Greece, 17671
Sponsors and Collaborators
Harokopio University
Graduate Program of the Department of Nutrition and Dietetics
Investigators
Principal Investigator: Elizabeth Fragopoulou, Chemist PhD Department of Nutrition-Dietetics, Harokopio University, Athens, Greece
  More Information

No publications provided

Responsible Party: Elizabeth Fragopoulou, PhD, Harokopio University
ClinicalTrials.gov Identifier: NCT01627912     History of Changes
Other Study ID Numbers: HUABIO01
Study First Received: June 14, 2012
Last Updated: June 22, 2012
Health Authority: Greece: Ethics Committee

Keywords provided by Harokopio University:
wine
inflammation
oxidative stress
randomized control trial
postprandial intervention
platelet aggregation
 haemostasis
robola
cabernet sauvignon
alcohol
PAF metabolism

ClinicalTrials.gov processed this record on May 16, 2013