Clinical trial NCT03614520: Evaluation of Bioavailability and Metabolism of Diet Phenolic Compounds
Official title: Evaluation of Bioavailability and Metabolism of Diet Phenolic Compounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A 40 people group of healthy men and women. Two Cohorts group of 20 healthy volunteers of both genders.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sub-study A : Basal dosing of urinary phenolic compounds and their metabolites concentrations
timeFrame: 2 hours before administration to administration (-2 to 0 hours)
measure: Sub-study A : Basal dosing of urinary phenolic compounds and their metabolites concentrations
timeFrame: 0-2 hours; 2-4 hours; 4-6 hours; 6-12 hours; 12-24 hours post administration
measure: Sub-study A : Postprandial dosing of plasmatic phenolic compounds and their metabolites concentrations
timeFrame: baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration
measure: Sub-study B : Basal dosing of urinary phenolic compounds and their metabolites concentrations
timeFrame: 2 hours before administration to administration (-2 to 0 hours)
measure: Sub-study B : Postprandial dosing of urinary phenolic compounds and their metabolites concentrations
timeFrame: 0-2 hours; 2-4 hours; 4-6 hours; 6-12 hours; 12-24 hours
Secondary outcomes:
measure: Sub-study A : Postprandial dosing of plasmatic glucose
timeFrame: baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration
measure: Sub-study A : Postprandial dosing of plasmatic insulin
timeFrame: baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration
measure: Sub-study A : Postprandial dosing of plasmatic total cholesterol
timeFrame: baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration
measure: Sub-study A : Postprandial dosing of plasmatic triglyceride
timeFrame: baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration
measure: Sub-study A : Postprandial dosing of plasmatic LDL
timeFrame: baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration
measure: Sub-study A : Postprandial dosing of plasmatic oxidated-LDL
timeFrame: baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration
measure: Sub-study A : Postprandial dosing of plasmatic HDL concentrations.
timeFrame: baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration
measure: Sub-study A : Basal cardiovascular activity : blood pressure
timeFrame: 15 minutes before administration
measure: Sub-study A : Basal cardiovascular activity: heart rate
timeFrame: 15 minutes before administration
measure: Sub-study A : Basal cardiovascular activity : endothelial function.
timeFrame: 15 minutes before administration
measure: Sub-study A : Postprandial cardiovascular activity : blood pressure
timeFrame: 1 hour and 2 hours post administration
measure: Sub-study A : Postprandial cardiovascular activity : heart rate
timeFrame: 1 hour and 2 hours post administration
measure: Sub-study A : Postprandial cardiovascular activity: endothelial function.
timeFrame: 1 hour and 2 hours post administration
measure: Sub-study B : Basal cardiovascular activity : blood pressure
timeFrame: 15 minutes before administration
measure: Sub-study B : Basal cardiovascular activity: heart rate.
timeFrame: 15 minutes before administration
measure: Sub-study B : Postprandial cardiovascular activity : blood pressure
timeFrame: 30 minutes, 1hour, 2 hours and 4 hours post administration
measure: Sub-study B : Postprandial cardiovascular activity: heart rate.
timeFrame: 30 minutes, 1hour, 2 hours and 4 hours post administration
measure: Sub-study B : Concentration of alcohol in the exhaled breath
timeFrame: 15 minutes before administration
measure: Sub-study B : Postprandial Concentration of alcohol in the exhaled breath
timeFrame: 30 minutes, 1hour, 2 hours and 4 hours post administration
measure: Sub-study B : Basal isoxanthohumol urinary concentration
timeFrame: 2 hours before administration to administration (-2 to 0 hours)
measure: Sub-study B : Postprandial isoxanthohumol urinary concentration
timeFrame: 0-2 hours; 2-4 hours; 4-6 hours; 6-12 hours; 12-24 hours post administration
measure: Sub-study B : Basal urinary creatinine concentration
timeFrame: 2 hours before administration to administration (-2 to 0 hours)
measure: Sub-study B : Basal urinary urinary pH.
timeFrame: 2 hours before administration to administration (-2 to 0 hours)
measure: Sub-study B : Postprandial urinary creatinine concentration
timeFrame: 0-2 hours; 2-4 hours; 4-6 hours; 6-12 hours; 12-24 hours post administration
measure: Sub-study B : Postprandial urinary urinary pH.
timeFrame: 0-2 hours; 2-4 hours; 4-6 hours; 6-12 hours; 12-24 hours post administration
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Consorci Parc de Salut Mar
Study officials:
affiliation: IMIM (Hospital del Mar Medical Research Institute)
name: Rafael de la Torre Fornell, Dr
role: PRINCIPAL_INVESTIGATOR
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