Healthy, PostprandialwinepostNCT01627912
Acute Effects of Wine Consumption on Healthy Volunteers
A study testing Robola, Cabernet Sauvignon wines in people with Healthy, Postprandial, run by Harokopio University at 1 site in Greece.
Trial 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 more about this study
- Who is it for?
- Ages 26 to 39 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Postprandial
- What is being tested?
- Robola, Cabernet Sauvignon wines
- How many people
- 10 participants
- Where
- 1 siteGreece
- Study dates
- Apr 2011to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 39 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- non-obese
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Nutrition-Dietetics, Harokopio University
Athens, 17671
About this study
Official title: 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.
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.
- Conditions
- Healthy, Postprandial
- Being tested
- Robola, Cabernet Sauvignon wines
- Keywords
- wine, inflammation, oxidative stress, randomized control trial, postprandial intervention, platelet aggregation, haemostasis, robola, cabernet sauvignon, alcohol, PAF metabolism
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robola, Cabernet Sauvignon winesOther
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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 300 min after standardized meal plus tested drink consumption.
markers of inflammation
Measured: baseline
markers of inflammation
Measured: 0 min after standardized meal plus tested drink consumption
markers of inflammation
Measured: 30 min after standardized meal plus tested drink consumption
markers of inflammation
Measured: 60 min after standardized meal plus tested drink consumption
markers of inflammation
Measured: 90 min after standardized meal plus tested drink consumption
markers of inflammation
Measured: 120 min after standardized meal plus tested drink consumption
markers of inflammation
Measured: 150 min after standardized meal plus tested drink consumption
markers of inflammation
Measured: 180 min after standardized meal plus tested drink consumption
markers of inflammation
Measured: 210 min after standardized meal plus tested drink consumption
markers of inflammation
Measured: 240 min after standardized meal plus tested drink consumption
markers of inflammation
Measured: 300 min after standardized meal plus tested drink consumption
markers of inflammation
Measured: 360 min after standardized meal plus tested drink consumption
markers of oxidative stress
TBARS, ex vivo serum oxidation etc
Measured: baseline
markers of oxidative stress
TBARS, ex vivo serum oxidation etc
Measured: 0 min after standardized meal plus tested drink consumption
markers of oxidative stress
TBARS, ex vivo serum oxidation etc
Measured: 30 min after standardized meal plus tested drink consumption
markers of oxidative stress
TBARS, ex vivo serum oxidation etc
Measured: 60 min after standardized meal plus tested drink consumption
markers of oxidative stress
TBARS, ex vivo serum oxidation etc
Measured: 90 min after standardized meal plus tested drink consumption
markers of oxidative stress
TBARS, ex vivo serum oxidation etc
Measured: 120 min after standardized meal plus tested drink consumption
markers of oxidative stress
TBARS, ex vivo serum oxidation etc
Measured: 150 min after standardized meal plus tested drink consumption
markers of oxidative stress
TBARS, ex vivo serum oxidation etc
Measured: 180 min after standardized meal plus tested drink consumption
markers of oxidative stress
TBARS, ex vivo serum oxidation etc
Measured: 210 min after standardized meal plus tested drink consumption
markers of oxidative stress
TBARS, ex vivo serum oxidation etc
Measured: 240 min after standardized meal plus tested drink consumption
markers of oxidative stress
TBARS, ex vivo serum oxidation etc
Measured: 300 min after standardized meal plus tested drink consumption
markers of oxidative stress
TBARS, ex vivo serum oxidation etc
Measured: 360 min after standardized meal plus tested drink consumption
PAF metabolism
Measurement of PAF biosynthetic / catabolic enzymes in leucocytes and LpPLA2 in serum
Measured: 0 min after standardized meal plus tested drink consumption
PAF metabolism
Measurement of PAF biosynthetic / catabolic enzymes in leucocytes and LpPLA2 in serum
Measured: 60 min after standardized meal plus tested drink consumption
PAF metabolism
Measurement of PAF biosynthetic / catabolic enzymes in leucocytes and LpPLA2 in serum
Measured: 90 min after standardized meal plus tested drink consumption
PAF metabolism
Measurement of PAF biosynthetic / catabolic enzymes in leucocytes and LpPLA2 in serum
Measured: 120 min after standardized meal plus tested drink consumption
PAF metabolism
Measurement of PAF biosynthetic / catabolic enzymes in leucocytes and LpPLA2 in serum
Measured: 180 min after standardized meal plus tested drink consumption
PAF metabolism
Measurement of PAF biosynthetic / catabolic enzymes in leucocytes and LpPLA2 in serum
Measured: 210 min after standardized meal plus tested drink consumption
PAF metabolism
Measurement of PAF biosynthetic / catabolic enzymes in leucocytes and LpPLA2 in serum
Measured: 240 min after standardized meal plus tested drink consumption
PAF metabolism
Measurement of PAF biosynthetic / catabolic enzymes in leucocytes and LpPLA2 in serum
Measured: 300 min after standardized meal plus tested drink consumption
PAF metabolism
Measurement of PAF biosynthetic / catabolic enzymes in leucocytes and LpPLA2 in serum
Measured: 360 min after standardized meal plus tested drink consumption
Secondary outcomes (29)
Glucose levels
Measured: baseline
Glucose levels
Measured: 0 min after standardized meal plus tested drink consumption
Glucose levels
Measured: 30 min after standardized meal plus tested drink consumption
Glucose levels
Measured: 60 min after standardized meal plus tested drink consumption
Glucose levels
Measured: 90 min after standardized meal plus tested drink consumption
Glucose levels
Measured: 120 min after standardized meal plus tested drink consumption
Glucose levels
Measured: 150 min after standardized meal plus tested drink consumption
Glucose levels
Measured: 180 min after standardized meal plus tested drink consumption
Glucose levels
Measured: 210 min after standardized meal plus tested drink consumption
Glucose levels
Measured: 240 min after standardized meal plus tested drink consumption
Glucose levels
Measured: 300 min after standardized meal plus tested drink consumption
Glucose levels
Measured: 360 min after standardized meal plus tested drink consumption
Insulin levels
Measured: 0 min after standardized meal plus tested drink consumption
Insulin levels
Measured: 30 min after standardized meal plus tested drink consumption
Insulin levels
Measured: 60 min after standardized meal plus tested drink consumption
Insulin levels
Measured: 90 min after standardized meal plus tested drink consumption
Insulin levels
Measured: 120 min after standardized meal plus tested drink consumption
lipids
HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides
Measured: baseline
lipids
HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides
Measured: 0 min after standardized meal plus tested drink consumption
lipids
HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides
Measured: 30 min after standardized meal plus tested drink consumption
lipids
HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides
Measured: 60 min after standardized meal plus tested drink consumption
lipids
HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides
Measured: 90 min after standardized meal plus tested drink consumption
lipids
HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides
Measured: 120 min after standardized meal plus tested drink consumption
lipids
HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides
Measured: 150 min after standardized meal plus tested drink consumption
lipids
HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides
Measured: 180 min after standardized meal plus tested drink consumption
lipids
HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides
Measured: 210 min after standardized meal plus tested drink consumption
lipids
HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides
Measured: 240 min after standardized meal plus tested drink consumption
lipids
HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides
Measured: 300 min after standardized meal plus tested drink consumption
lipids
HDL-cholesterol, LDL-cholesterol, total chlesterol, triglycerides
Measured: 360 min after standardized meal plus tested drink consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2012 (estimated)
- Study startApr 2011
- Primary completionOct 2011
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy, PostprandialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harokopio University
- Sponsor type
- University, hospital or other
- Collaborators
- Graduate Program of the Department of Nutrition and Dietetics
- Responsible party
- Principal investigator, Elizabeth Fragopoulou, Harokopio University
- Investigators
- Elizabeth Fragopoulou, Chemist PhD, Principal investigator, Department of Nutrition-Dietetics, Harokopio University, Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01627912
- Sponsor's protocol ID
- HUABIO01
- Acronym
- winepost
- Status last verified
- Jun 2012
- First submitted
- 14 Jun 2012
- Last updated
- 26 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Wine Consumption on Platelet Aggregation, and on Inflammatory / Oxidative Stress Markers
- ClinicalTrials.gov ID
- NCT01627912
- Acronym / sponsor ID
- winepost / HUABIO01
- Conditions
- Healthy, Postprandial
- Keywords
- wine, inflammation, oxidative stress, randomized control trial, postprandial intervention, platelet aggregation, haemostasis, robola
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Harokopio UniversityUniversity, hospital or other
- Collaborators
- Graduate Program of the Department of Nutrition and Dietetics
- Study start
- Apr 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2012 (estimated)
- First posted
- 26 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 26 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy
- non-obese
Key exclusion criteria (8 listed)
- smokers
- those who reported slimming or any other dietary regime
- abstainers from alcohol consumption
- heavy drinkers
- athletes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robola, Cabernet Sauvignon wines4 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. | Other | – |
Primary outcome
platelet aggregation
Time frame: baseline
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.
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.
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
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.
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.
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
markers of inflammation
Time frame: 0 min after standardized meal plus tested drink consumption
markers of inflammation
Time frame: 30 min after standardized meal plus tested drink consumption
markers of inflammation
Time frame: 60 min after standardized meal plus tested drink consumption
markers of inflammation
Time frame: 90 min after standardized meal plus tested drink consumption
markers of inflammation
Time frame: 120 min after standardized meal plus tested drink consumption
markers of inflammation
Time frame: 150 min after standardized meal plus tested drink consumption
markers of inflammation
Time frame: 180 min after standardized meal plus tested drink consumption
markers of inflammation
Time frame: 210 min after standardized meal plus tested drink consumption
markers of inflammation
Time frame: 240 min after standardized meal plus tested drink consumption
markers of inflammation
Time frame: 300 min after standardized meal plus tested drink consumption
markers of inflammation
Time frame: 360 min after standardized meal plus tested drink consumption
markers of oxidative stress
Time frame: baseline
TBARS, ex vivo serum oxidation etc
markers of oxidative stress
Time frame: 0 min after standardized meal plus tested drink consumption
TBARS, ex vivo serum oxidation etc
markers of oxidative stress
Time frame: 30 min after standardized meal plus tested drink consumption
TBARS, ex vivo serum oxidation etc
markers of oxidative stress
Time frame: 60 min after standardized meal plus tested drink consumption
TBARS, ex vivo serum oxidation etc
markers of oxidative stress
Time frame: 90 min after standardized meal plus tested drink consumption
TBARS, ex vivo serum oxidation etc
markers of oxidative stress
Time frame: 120 min after standardized meal plus tested drink consumption
TBARS, ex vivo serum oxidation etc
markers of oxidative stress
Time frame: 150 min after standardized meal plus tested drink consumption
TBARS, ex vivo serum oxidation etc
markers of oxidative stress
Time frame: 180 min after standardized meal plus tested drink consumption
TBARS, ex vivo serum oxidation etc
markers of oxidative stress
Time frame: 210 min after standardized meal plus tested drink consumption
TBARS, ex vivo serum oxidation etc
markers of oxidative stress
Time frame: 240 min after standardized meal plus tested drink consumption
TBARS, ex vivo serum oxidation etc
markers of oxidative stress
Time frame: 300 min after standardized meal plus tested drink consumption
TBARS, ex vivo serum oxidation etc
markers of oxidative stress
Time frame: 360 min after standardized meal plus tested drink consumption
TBARS, ex vivo serum oxidation etc
PAF metabolism
Time frame: 0 min after standardized meal plus tested drink consumption
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
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
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
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
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
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
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
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
Measurement of PAF biosynthetic / catabolic enzymes in leucocytes and LpPLA2 in serum
29 secondary outcomes
Glucose levels
Time frame: baseline
Glucose levels
Time frame: 0 min after standardized meal plus tested drink consumption
Glucose levels
Time frame: 30 min after standardized meal plus tested drink consumption
Glucose levels
Time frame: 60 min after standardized meal plus tested drink consumption
Glucose levels
Time frame: 90 min after standardized meal plus tested drink consumption
Glucose levels
Time frame: 120 min after standardized meal plus tested drink consumption
Glucose levels
Time frame: 150 min after standardized meal plus tested drink consumption
Glucose levels
Time frame: 180 min after standardized meal plus tested drink consumption
Glucose levels
Time frame: 210 min after standardized meal plus tested drink consumption
Glucose levels
Time frame: 240 min after standardized meal plus tested drink consumption
Glucose levels
Time frame: 300 min after standardized meal plus tested drink consumption
Glucose levels
Time frame: 360 min after standardized meal plus tested drink consumption
Insulin levels
Time frame: 0 min after standardized meal plus tested drink consumption
Insulin levels
Time frame: 30 min after standardized meal plus tested drink consumption
Insulin levels
Time frame: 60 min after standardized meal plus tested drink consumption
Insulin levels
Time frame: 90 min after standardized meal plus tested drink consumption
Insulin levels
Time frame: 120 min after standardized meal plus tested drink consumption
lipids
Time frame: baseline
lipids
Time frame: 0 min after standardized meal plus tested drink consumption
lipids
Time frame: 30 min after standardized meal plus tested drink consumption
lipids
Time frame: 60 min after standardized meal plus tested drink consumption
lipids
Time frame: 90 min after standardized meal plus tested drink consumption
lipids
Time frame: 120 min after standardized meal plus tested drink consumption
lipids
Time frame: 150 min after standardized meal plus tested drink consumption
lipids
Time frame: 180 min after standardized meal plus tested drink consumption
lipids
Time frame: 210 min after standardized meal plus tested drink consumption
lipids
Time frame: 240 min after standardized meal plus tested drink consumption
lipids
Time frame: 300 min after standardized meal plus tested drink consumption
lipids
Time frame: 360 min after standardized meal plus tested drink consumption
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Fragopoulou, Chemist PhD principal investigator
Department of Nutrition-Dietetics, Harokopio University, Athens, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robola, Cabernet Sauvignon wines in people with Healthy, Postprandial, run by Harokopio University at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
platelet aggregation (time frame: baseline). The study lists 39 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2012.