Evaluation of Bioavailability and Metabolism of Diet Phenolic Compounds

Parc de Salut Mar20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Administration of olive oilOTHER

25 mL of extra virgin olive oil

Administration of red wineOTHER

150 mL or Red Wine

Combination of red wine and olive oilOTHER

150 mL of Red wine + 25 mL of Extra Virgin Olive oil will be administred at the same time

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Consorci Parc de Salut Mar

Barcelona, Spain

Outcomes

Primary Outcomes

Sub-study A : Basal dosing of urinary phenolic compounds and their metabolites concentrations

Time frame: 2 hours before administration to administration (-2 to 0 hours)

Sub-study A : Basal dosing of urinary phenolic compounds and their metabolites concentrations

Time frame: 0-2 hours; 2-4 hours; 4-6 hours; 6-12 hours; 12-24 hours post administration

Sub-study A : Postprandial dosing of plasmatic phenolic compounds and their metabolites concentrations

Time frame: 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

Time frame: 2 hours before administration to administration (-2 to 0 hours)

Sub-study B : Postprandial dosing of urinary phenolic compounds and their metabolites concentrations

Time frame: 0-2 hours; 2-4 hours; 4-6 hours; 6-12 hours; 12-24 hours

Secondary Outcomes

Sub-study A : Postprandial dosing of plasmatic glucose

Time frame: baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration

Sub-study A : Postprandial dosing of plasmatic insulin

Time frame: 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

Time frame: baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Mineral water will be given as placebo

Dark beerOTHER

250 mL of IPA beer (alcohol 8.5% vol)

Light BeerOTHER

250 mL of blonde ale beer (alcohol 4,5% vol)

Alcohol free BeerOTHER

250 mL of alcohol free beer (alcohol 0.0% vol)

Sub-study A : Postprandial dosing of plasmatic triglyceride

Time frame: baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration

Sub-study A : Postprandial dosing of plasmatic LDL

Time frame: 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

Time frame: 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.

Time frame: baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration

Sub-study A : Basal cardiovascular activity : blood pressure

Time frame: 15 minutes before administration

Sub-study A : Basal cardiovascular activity: heart rate

Time frame: 15 minutes before administration

Sub-study A : Basal cardiovascular activity : endothelial function.

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

Time frame: 15 minutes before administration

Sub-study A : Postprandial cardiovascular activity : blood pressure

Time frame: 1 hour and 2 hours post administration

Sub-study A : Postprandial cardiovascular activity : heart rate

Time frame: 1 hour and 2 hours post administration

Sub-study A : Postprandial cardiovascular activity: endothelial function.

Time frame: 1 hour and 2 hours post administration

Sub-study B : Basal cardiovascular activity : blood pressure

Time frame: 15 minutes before administration

Sub-study B : Basal cardiovascular activity: heart rate.

Time frame: 15 minutes before administration

Sub-study B : Postprandial cardiovascular activity : blood pressure

Time frame: 30 minutes, 1hour, 2 hours and 4 hours post administration

Sub-study B : Postprandial cardiovascular activity: heart rate.

Time frame: 30 minutes, 1hour, 2 hours and 4 hours post administration

Sub-study B : Concentration of alcohol in the exhaled breath

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.

Time frame: 15 minutes before administration

Sub-study B : Postprandial Concentration of alcohol in the exhaled breath

Time frame: 30 minutes, 1hour, 2 hours and 4 hours post administration

Sub-study B : Basal isoxanthohumol urinary concentration

Isoxanthohumol is a biomarker of beer consumption.

Time frame: 2 hours before administration to administration (-2 to 0 hours)

Sub-study B : Postprandial isoxanthohumol urinary concentration

Isoxanthohumol is a biomarker of beer consumption.

Time frame: 0-2 hours; 2-4 hours; 4-6 hours; 6-12 hours; 12-24 hours post administration

Sub-study B : Basal urinary creatinine concentration

Time frame: 2 hours before administration to administration (-2 to 0 hours)

Sub-study B : Basal urinary urinary pH.

pH is a logarithmic scale used to specify the acidity or basicity of an aqueous solution.

Time frame: 2 hours before administration to administration (-2 to 0 hours)

Sub-study B : Postprandial urinary creatinine concentration

Time frame: 0-2 hours; 2-4 hours; 4-6 hours; 6-12 hours; 12-24 hours post administration

Sub-study B : Postprandial urinary urinary pH.

pH is a logarithmic scale used to specify the acidity or basicity of an aqueous solution.

Time frame: 0-2 hours; 2-4 hours; 4-6 hours; 6-12 hours; 12-24 hours post administration