Evaluation of Bioavailability and Metabolism of Diet Phenolic Compounds (dopet4)

Parc de Salut Mar

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Other: Administration of olive oil; Other: Water; Other: Combination of red wine and olive oil; Other: Administration of red wine; Other: Light Beer; Other: Dark beer; Other: Alcohol free Beer

Study type: Interventional

Funder types: Other

Identifiers

NCT03614520

IMIMFTCL/DOPET4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Other: Combination of red wine and olive oil

Other: Administration of olive oil

Other: Water

Other: Administration of red wine

Sub-study B : three types of beer, and wine

Experimental group

Description:

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.

Treatment:

Other: Alcohol free Beer

Other: Dark beer

Other: Light Beer

Other: Administration of red wine