dopet4: Evaluation of Bioavailability and Metabolism of Diet Phenolic Compounds

Sponsor

Parc de Salut Mar (Other)

Overall Status

Completed

CT.gov ID

NCT03614520

Collaborator

(none)

Enrollment

Location

Arms

7.7

Actual Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Administration of olive oil Other: Administration of red wine Other: Combination of red wine and olive oil Other: Water Other: Dark beer Other: Light Beer Other: Alcohol free Beer	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

A 40 people group of healthy men and women. Two Cohorts group of 20 healthy volunteers of both genders.A 40 people group of healthy men and women. Two Cohorts group of 20 healthy volunteers of both genders.

Masking:

None (Open Label)

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).

Primary Purpose:

Health Services Research

Official Title:

Evaluation of Bioavailability and Metabolism of Diet Phenolic Compounds

Actual Study Start Date :

Jul 9, 2018

Actual Primary Completion Date :

Feb 27, 2019

Actual Study Completion Date :

Feb 27, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sub-study A : olive oil, wine, both, or water (placebo). 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.	Other: Administration of olive oil 25 mL of extra virgin olive oil Other: Administration of red wine 150 mL or Red Wine Other: Combination 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 Other: Water Mineral water will be given as placebo
Experimental: Sub-study B : three types of beer, and 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.	Other: Administration of red wine 150 mL or Red Wine Other: Dark beer 250 mL of IPA beer (alcohol 8.5% vol) Other: Light Beer 250 mL of blonde ale beer (alcohol 4,5% vol) Other: Alcohol free Beer 250 mL of alcohol free beer (alcohol 0.0% vol)

Arm

Intervention/Treatment

Experimental: Sub-study A : olive oil, wine, both, or water (placebo).

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.

Other: Administration of olive oil

25 mL of extra virgin olive oil

Other: Administration of red wine

150 mL or Red Wine

Other: Combination 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

Other: Water

Mineral water will be given as placebo

Experimental: Sub-study B : three types of beer, and 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.

Other: Administration of red wine

150 mL or Red Wine

Other: Dark beer

250 mL of IPA beer (alcohol 8.5% vol)

Other: Light Beer

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

Other: Alcohol free Beer

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

Outcome Measures

Primary Outcome Measures

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 : 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]
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 Outcome Measures

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 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]
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 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 : blood pressure [15 minutes before administration]
Sub-study B : Basal cardiovascular activity: heart rate. [15 minutes before 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Consorci Parc de Salut Mar	Barcelona		Spain	08017

Sponsors and Collaborators

Parc de Salut Mar

Investigators

Principal Investigator: Rafael de la Torre Fornell, Dr, IMIM (Hospital del Mar Medical Research Institute)

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Rafael de la Torre, Director of the Neurosciences Department in IMIM, Parc de Salut Mar

ClinicalTrials.gov Identifier:

NCT03614520

Other Study ID Numbers:

IMIMFTCL/DOPET4

First Posted:

Aug 3, 2018

Last Update Posted:

Mar 5, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 5, 2020