Healthy
Conditions
Brief summary
This study aims at studying in depth the absorption and metabolism of phenolic compounds of olive oil, wine and beer. This study is divided into 2 sub-studies in order to evaluate each one of the objectives.
Detailed description
The study is divided in two sub-studies to explore each objective. One the one hand, a group of people will drink olive oil, or wine, or both. This is done to see if combining these two drinks will improve the absorption and bioavailibility of phenolic compounds that they contain, promoting by synergy their antioxidant activity at a postprandial level. The main compounds studied are the Resveratrol (RSVT), the Hydroxytyrosol (HT), tyrosol (TIR) and their metabolits. One the other hand, an group of people will drink 3 different beers ( with 3 different degrees of alcohol), or wine, in order to study the absorption of TIR in relation to the alcohol degree. It also aims at assessing if the gas contained in beer contributes to TIR absorption. At different times after the administration of drinks, urine and blood samples will be collected.
Interventions
OTHERAdministration of olive oil
25 mL of extra virgin olive oil
OTHERAdministration of red wine
150 mL or Red Wine
OTHERCombination of red wine and olive oil
150 mL of Red wine + 25 mL of Extra Virgin Olive oil will be administred at the same time
OTHERWater
Mineral water will be given as placebo
OTHERDark beer
250 mL of IPA beer (alcohol 8.5% vol)
OTHERLight Beer
250 mL of blonde ale beer (alcohol 4,5% vol)
OTHERAlcohol free Beer
250 mL of alcohol free beer (alcohol 0.0% vol)
Sponsors
Parc de Salut Mar
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
The subjects, because of the wine taste that cannot be hidden, will know what they drink, except from the three beers (the three types will not be distinguishable).
Intervention model description
A 40 people group of healthy men and women. Two Cohorts group of 20 healthy volunteers of both genders.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Men and women from 18 to 45 years old. * Understand and accepting the procedures of the trial and sign an informed consent. * Have a history and physical exams that show that there is no organic issue, and an analysis and ECG in the normal limits. * Have an BMI between 18.5 and 30 kg/m2. * caucasian race
Exclusion criteria
* Smokers * Persons with chronical disease * Persons with BMI\>30 or \<18.5 kg/m2. * Persons with history of multiple allergies or obvious intestinal, hepatic, renal issues or other problems that could suppose a deterioration of absorption, distribution or metabolism of polyphenols. * Persons who take anti-oxidant products, including vitamins, herbal medication or dietetics complementation that could interfere in the study objectives. * Persons with restrictive diet (including vegetarian diet). * Persons with history of hypersensibility or intolerance to alcohol. * Persons with a daily consumption of alcohol \>50g or who have consumed illegal drug in the month preceding the study. * Persons who have participated in an other clinical trial the month preceding the study. * Persons who have done a blood donation during the last 3 months before the beginning of the study (only appliable to the subjects of A sub-study). * Persons who have a positive serology for B or C hepatitis or HIV. * Pregnant or breastfeeding women, or any other situation prohibiting alcohol consumption. * Persons who have consummed NSAIDs (especially acetylsalicylic acid) or antioxidants or vitamin complementation, during the 2 weeks preceding the beginning of the study. * Illiterate persons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sub-study A : Basal dosing of urinary phenolic compounds and their metabolites concentrations | 2 hours before administration to administration (-2 to 0 hours) |
| Sub-study A : Postprandial dosing of plasmatic phenolic compounds and their metabolites concentrations | baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration |
| Sub-study B : Basal dosing of urinary phenolic compounds and their metabolites concentrations | 2 hours before administration to administration (-2 to 0 hours) |
| Sub-study B : Postprandial dosing of urinary phenolic compounds and their metabolites concentrations | 0-2 hours; 2-4 hours; 4-6 hours; 6-12 hours; 12-24 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sub-study A : Postprandial cardiovascular activity: endothelial function. | 1 hour and 2 hours post administration | Endothelial function will be assessed as flow-mediated dilation using endoPAT 2000 (Itamar Medical device). Flow-mediated dilation is the most widely used method to test endothelial function since it is non-invasive, and measures by ultrasounds the response to increased shear stress, commonly in the brachial artery |
| Sub-study A : Postprandial dosing of plasmatic LDL | baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration | — |
| Sub-study A : Postprandial dosing of plasmatic oxidated-LDL | baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration | — |
| Sub-study A : Postprandial dosing of plasmatic HDL concentrations. | baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration | — |
| Sub-study A : Basal cardiovascular activity : blood pressure | 15 minutes before administration | — |
| Sub-study A : Basal cardiovascular activity: heart rate | 15 minutes before administration | — |
| Sub-study A : Basal cardiovascular activity : endothelial function. | 15 minutes before administration | Endothelial function will be assessed as flow-mediated dilation using endoPAT 2000 (Itamar Medical device). Flow-mediated dilation is the most widely used method to test endothelial function since it is non-invasive, and measures by ultrasounds the response to increased shear stress, commonly in the brachial artery |
| Sub-study A : Postprandial cardiovascular activity : blood pressure | 1 hour and 2 hours post administration | — |
| Sub-study A : Postprandial cardiovascular activity : heart rate | 1 hour and 2 hours post administration | — |
| Sub-study B : Basal cardiovascular activity : blood pressure | 15 minutes before administration | — |
| Sub-study A : Postprandial dosing of plasmatic glucose | baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration | — |
| Sub-study B : Postprandial cardiovascular activity : blood pressure | 30 minutes, 1hour, 2 hours and 4 hours post administration | — |
| Sub-study B : Postprandial cardiovascular activity: heart rate. | 30 minutes, 1hour, 2 hours and 4 hours post administration | — |
| Sub-study B : Concentration of alcohol in the exhaled breath | 15 minutes before administration | Blood alcohol (ethanol) concentration is correlated with the concentration of alcohol in the exhaled breath at end-exhalation (BrAC). It is a non-invasive method that has been used to quantify alcohol intake. |
| Sub-study B : Postprandial Concentration of alcohol in the exhaled breath | 30 minutes, 1hour, 2 hours and 4 hours post administration | Blood alcohol (ethanol) concentration is correlated with the concentration of alcohol in the exhaled breath at end-exhalation (BrAC). It is a non-invasive method that has been used to quantify alcohol intake. |
| Sub-study B : Basal isoxanthohumol urinary concentration | 2 hours before administration to administration (-2 to 0 hours) | Isoxanthohumol is a biomarker of beer consumption. |
| Sub-study B : Postprandial isoxanthohumol urinary concentration | 0-2 hours; 2-4 hours; 4-6 hours; 6-12 hours; 12-24 hours post administration | Isoxanthohumol is a biomarker of beer consumption. |
| Sub-study B : Basal urinary creatinine concentration | 2 hours before administration to administration (-2 to 0 hours) | — |
| Sub-study B : Basal urinary urinary pH. | 2 hours before administration to administration (-2 to 0 hours) | pH is a logarithmic scale used to specify the acidity or basicity of an aqueous solution. |
| Sub-study B : Postprandial urinary creatinine concentration | 0-2 hours; 2-4 hours; 4-6 hours; 6-12 hours; 12-24 hours post administration | — |
| Sub-study B : Postprandial urinary urinary pH. | 0-2 hours; 2-4 hours; 4-6 hours; 6-12 hours; 12-24 hours post administration | pH is a logarithmic scale used to specify the acidity or basicity of an aqueous solution. |
| Sub-study B : Basal cardiovascular activity: heart rate. | 15 minutes before administration | — |
| Sub-study A : Postprandial dosing of plasmatic insulin | baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration | — |
| Sub-study A : Postprandial dosing of plasmatic total cholesterol | baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration | — |
| Sub-study A : Postprandial dosing of plasmatic triglyceride | baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration | — |
Countries
Spain
Outcome results
None listed