Acute Effects of Wine Consumption on Healthy Volunteers

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy, Postprandial

Intervention / Treatment
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* Other: Robola, Cabernet Sauvignon wines


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 26 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wine, inflammation, oxidative stress, randomized control trial, postprandial intervention, platelet aggregation, haemostasis, robola, cabernet sauvignon, alcohol, PAF metabolism