Acute Effects of Wine Consumption on Healthy Volunteers (winepost)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Harokopio University.
Recruitment status was  Active, not recruiting
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

June 14, 2012
June 22, 2012
April 2011
October 2011   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01627912 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Acute Effects of Wine Consumption on Healthy Volunteers
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Healthy, Postprandial
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
10
October 2012
October 2011   (final data collection date for primary outcome measure)

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
Male
26 Years to 39 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT01627912
HUABIO01
No
Elizabeth Fragopoulou, Harokopio University
Harokopio University
Graduate Program of the Department of Nutrition and Dietetics
Principal Investigator: Elizabeth Fragopoulou, Chemist PhD Department of Nutrition-Dietetics, Harokopio University, Athens, Greece
Harokopio University
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP