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Status unknownNCT01627912winepostUpdated Jun 26, 2012

Acute Effects of Wine Consumption on Healthy Volunteers

An interventional study of Robola, Cabernet Sauvignon wines in Healthy, Postprandial, sponsored by Harokopio University. Status unknown at 1 site in Greece. Open to male participants aged 26 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-06-26.

Sponsored by Harokopio University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jun 2012), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
26 Years to 39 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy, Postprandial

Keywords

  • wine
  • inflammation
  • oxidative stress
  • randomized control trial
  • postprandial intervention
  • platelet aggregation
  • haemostasis
  • robola
  • cabernet sauvignon
  • alcohol
  • PAF metabolism
03

In context

Lead sponsor

Harokopio University is the lead sponsor of 65 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
26 Years to 39 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • healthy
  • non-obese

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
10 participants (actual)

Interventions

  • OtherRobola, 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline

  2. 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.

    Time frame: 30 min after standardized meal plus tested drink consumption.

  3. 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.

    Time frame: 90 min after standardized meal plus tested drink consumption.

  4. 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.

    Time frame: 150 min after standardized meal plus tested drink consumption

  5. 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.

    Time frame: 210 min after standardized meal plus tested drink consumption.

  6. 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.

    Time frame: 300 min after standardized meal plus tested drink consumption.

  7. markers of inflammation

    Time frame: baseline

  8. markers of inflammation

    Time frame: 0 min after standardized meal plus tested drink consumption

  9. markers of inflammation

    Time frame: 30 min after standardized meal plus tested drink consumption

  10. markers of inflammation

    Time frame: 60 min after standardized meal plus tested drink consumption

  11. markers of inflammation

    Time frame: 90 min after standardized meal plus tested drink consumption

  12. markers of inflammation

    Time frame: 120 min after standardized meal plus tested drink consumption

  13. markers of inflammation

    Time frame: 150 min after standardized meal plus tested drink consumption

  14. markers of inflammation

    Time frame: 180 min after standardized meal plus tested drink consumption

  15. markers of inflammation

    Time frame: 210 min after standardized meal plus tested drink consumption

  16. markers of inflammation

    Time frame: 240 min after standardized meal plus tested drink consumption

  17. markers of inflammation

    Time frame: 300 min after standardized meal plus tested drink consumption

  18. markers of inflammation

    Time frame: 360 min after standardized meal plus tested drink consumption

  19. markers of oxidative stress

    TBARS, ex vivo serum oxidation etc

    Time frame: baseline

  20. markers of oxidative stress

    TBARS, ex vivo serum oxidation etc

    Time frame: 0 min after standardized meal plus tested drink consumption

  21. markers of oxidative stress

    TBARS, ex vivo serum oxidation etc

    Time frame: 30 min after standardized meal plus tested drink consumption

  22. markers of oxidative stress

    TBARS, ex vivo serum oxidation etc

    Time frame: 60 min after standardized meal plus tested drink consumption

  23. markers of oxidative stress

    TBARS, ex vivo serum oxidation etc

    Time frame: 90 min after standardized meal plus tested drink consumption

  24. markers of oxidative stress

    TBARS, ex vivo serum oxidation etc

    Time frame: 120 min after standardized meal plus tested drink consumption

  25. markers of oxidative stress

    TBARS, ex vivo serum oxidation etc

    Time frame: 150 min after standardized meal plus tested drink consumption

  26. markers of oxidative stress

    TBARS, ex vivo serum oxidation etc

    Time frame: 180 min after standardized meal plus tested drink consumption

  27. markers of oxidative stress

    TBARS, ex vivo serum oxidation etc

    Time frame: 210 min after standardized meal plus tested drink consumption

  28. markers of oxidative stress

    TBARS, ex vivo serum oxidation etc

    Time frame: 240 min after standardized meal plus tested drink consumption

  29. markers of oxidative stress

    TBARS, ex vivo serum oxidation etc

    Time frame: 300 min after standardized meal plus tested drink consumption

  30. markers of oxidative stress

    TBARS, ex vivo serum oxidation etc

    Time frame: 360 min after standardized meal plus tested drink consumption

  31. PAF metabolism

    Measurement of PAF biosynthetic / catabolic enzymes in leucocytes and LpPLA2 in serum

    Time frame: 0 min after standardized meal plus tested drink consumption

  32. PAF metabolism

    Measurement of PAF biosynthetic / catabolic enzymes in leucocytes and LpPLA2 in serum

    Time frame: 60 min after standardized meal plus tested drink consumption

  33. PAF metabolism

    Measurement of PAF biosynthetic / catabolic enzymes in leucocytes and LpPLA2 in serum

    Time frame: 90 min after standardized meal plus tested drink consumption

  34. PAF metabolism

    Measurement of PAF biosynthetic / catabolic enzymes in leucocytes and LpPLA2 in serum

    Time frame: 120 min after standardized meal plus tested drink consumption

  35. PAF metabolism

    Measurement of PAF biosynthetic / catabolic enzymes in leucocytes and LpPLA2 in serum

    Time frame: 180 min after standardized meal plus tested drink consumption

  36. PAF metabolism

    Measurement of PAF biosynthetic / catabolic enzymes in leucocytes and LpPLA2 in serum

    Time frame: 210 min after standardized meal plus tested drink consumption

  37. PAF metabolism

    Measurement of PAF biosynthetic / catabolic enzymes in leucocytes and LpPLA2 in serum

    Time frame: 240 min after standardized meal plus tested drink consumption

  38. PAF metabolism

    Measurement of PAF biosynthetic / catabolic enzymes in leucocytes and LpPLA2 in serum

    Time frame: 300 min after standardized meal plus tested drink consumption

  39. PAF metabolism

    Measurement of PAF biosynthetic / catabolic enzymes in leucocytes and LpPLA2 in serum

    Time frame: 360 min after standardized meal plus tested drink consumption

Secondary outcomes

  1. Glucose levels

    Time frame: baseline

  2. Glucose levels

    Time frame: 0 min after standardized meal plus tested drink consumption

  3. Glucose levels

    Time frame: 30 min after standardized meal plus tested drink consumption

  4. Glucose levels

    Time frame: 60 min after standardized meal plus tested drink consumption

  5. Glucose levels

    Time frame: 90 min after standardized meal plus tested drink consumption

  6. Glucose levels

    Time frame: 120 min after standardized meal plus tested drink consumption

  7. Glucose levels

    Time frame: 150 min after standardized meal plus tested drink consumption

  8. Glucose levels

    Time frame: 180 min after standardized meal plus tested drink consumption

  9. Glucose levels

    Time frame: 210 min after standardized meal plus tested drink consumption

  10. Glucose levels

    Time frame: 240 min after standardized meal plus tested drink consumption

  11. Glucose levels

    Time frame: 300 min after standardized meal plus tested drink consumption

  12. Glucose levels

    Time frame: 360 min after standardized meal plus tested drink consumption

  13. Insulin levels

    Time frame: 0 min after standardized meal plus tested drink consumption

  14. Insulin levels

    Time frame: 30 min after standardized meal plus tested drink consumption

  15. Insulin levels

    Time frame: 60 min after standardized meal plus tested drink consumption

  16. Insulin levels

    Time frame: 90 min after standardized meal plus tested drink consumption

  17. Insulin levels

    Time frame: 120 min after standardized meal plus tested drink consumption

  18. lipids

    HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides

    Time frame: baseline

  19. lipids

    HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides

    Time frame: 0 min after standardized meal plus tested drink consumption

  20. lipids

    HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides

    Time frame: 30 min after standardized meal plus tested drink consumption

  21. lipids

    HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides

    Time frame: 60 min after standardized meal plus tested drink consumption

  22. lipids

    HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides

    Time frame: 90 min after standardized meal plus tested drink consumption

  23. lipids

    HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides

    Time frame: 120 min after standardized meal plus tested drink consumption

  24. lipids

    HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides

    Time frame: 150 min after standardized meal plus tested drink consumption

  25. lipids

    HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides

    Time frame: 180 min after standardized meal plus tested drink consumption

  26. lipids

    HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides

    Time frame: 210 min after standardized meal plus tested drink consumption

  27. lipids

    HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides

    Time frame: 240 min after standardized meal plus tested drink consumption

  28. lipids

    HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides

    Time frame: 300 min after standardized meal plus tested drink consumption

  29. lipids

    HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides

    Time frame: 360 min after standardized meal plus tested drink consumption

07

Study locations

1 site
  • Department of Nutrition-Dietetics, Harokopio University
    Athens, 17671, Greece
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01627912
Lead sponsor
Harokopio University
Collaborators
Graduate Program of the Department of Nutrition and Dietetics
Responsible party
Elizabeth Fragopoulou (PhD, Harokopio University) — Principal investigator
First posted
Jun 26, 2012
Start date
Apr 2011
Primary completion
Oct 2011
Completion
Oct 2012 (estimated)
Last update
Jun 26, 2012

Study contacts

Elizabeth Fragopoulou, Chemist PhD
principal investigator · Department of Nutrition-Dietetics, Harokopio University, Athens, Greece

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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