Evaluation of Bioavailability and Metabolism of Diet Phenolic Compounds

Phase 1

Completed

• Conditions: Healthy
• Interventions: Other: Administration of olive oil; Other: Dark beer; Other: Administration of red wine; Other: Combination of red wine and olive oil; Other: Light Beer; Other: Water; Other: Alcohol free Beer

• Registration Number: NCT03614520
• Lead Sponsor: Parc de Salut Mar

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.

Study Timeline

• Study Start: 2018-07-09
• Study First Submitted: 2018-07-10
• Study First Submitted QC: 2018-08-02
• Study First Posted: 2018-08-03
• Primary Completion: 2019-02-27
• Study Completion: 2019-02-27
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-04
• Last Update Posted: 2020-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sub-study A : olive oil, wine, both, or water (placebo).	Water	After being selected, subjects will do 4 experimental sessions (each separated by 3 days minimum) in which ones they will drink olive oil, red wine, red wine and olive oil, or water (placebo). The order of the experimental sessions will be drawn.
Sub-study B : three types of beer, and wine	Alcohol free Beer	The subjects will do 4 experimental sessions (each separated by 3 days minimum) in wich ones they will drink a beer (250mL) or wine (150mL). The order of the experimental sessions will be drawn.
Sub-study A : olive oil, wine, both, or water (placebo).	Combination of red wine and olive oil	After being selected, subjects will do 4 experimental sessions (each separated by 3 days minimum) in which ones they will drink olive oil, red wine, red wine and olive oil, or water (placebo). The order of the experimental sessions will be drawn.
Sub-study B : three types of beer, and wine	Dark beer	The subjects will do 4 experimental sessions (each separated by 3 days minimum) in wich ones they will drink a beer (250mL) or wine (150mL). The order of the experimental sessions will be drawn.
Sub-study A : olive oil, wine, both, or water (placebo).	Administration of olive oil	After being selected, subjects will do 4 experimental sessions (each separated by 3 days minimum) in which ones they will drink olive oil, red wine, red wine and olive oil, or water (placebo). The order of the experimental sessions will be drawn.
Sub-study A : olive oil, wine, both, or water (placebo).	Administration of red wine	After being selected, subjects will do 4 experimental sessions (each separated by 3 days minimum) in which ones they will drink olive oil, red wine, red wine and olive oil, or water (placebo). The order of the experimental sessions will be drawn.
Sub-study B : three types of beer, and wine	Administration of red wine	The subjects will do 4 experimental sessions (each separated by 3 days minimum) in wich ones they will drink a beer (250mL) or wine (150mL). The order of the experimental sessions will be drawn.
Sub-study B : three types of beer, and wine	Light Beer	The subjects will do 4 experimental sessions (each separated by 3 days minimum) in wich ones they will drink a beer (250mL) or wine (150mL). The order of the experimental sessions will be drawn.

Primary Outcome Measures

Name	Time	Method
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
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 A : Basal dosing of urinary phenolic compounds and their metabolites concentrations	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	baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration

Secondary Outcome Measures

Name	Time	Method
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 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 : 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 A : Postprandial dosing of plasmatic triglyceride	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 : 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 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 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 : Basal cardiovascular activity : blood pressure	15 minutes before administration
Sub-study A : Postprandial cardiovascular activity : blood pressure	1 hour and 2 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 : 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 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 HDL concentrations.	baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration
Sub-study A : Basal cardiovascular activity: heart rate	15 minutes before administration
Sub-study A : Postprandial cardiovascular activity : heart rate	1 hour and 2 hours post administration
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 B : Basal cardiovascular activity: heart rate.	15 minutes before administration
Sub-study B : Basal urinary creatinine concentration	2 hours before administration to administration (-2 to 0 hours)
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.

Trial Locations

Locations (1)

Consorci Parc de Salut Mar; 🇪🇸 Barcelona, Spain