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Completed

NCT Number: NCT03614520

Evaluation of Bioavailability and Metabolism of Diet Phenolic Compounds

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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Consorci Parc de Salut Mar

Barcelona, 08017, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Administration of olive oil

Other

25 mL of extra virgin olive oil

Administration of red wine

Other

150 mL or Red Wine

Combination of red wine and olive oil

Other

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

Water

Other

Mineral water will be given as placebo

Dark beer

Other

250 mL of IPA beer (alcohol 8.5% vol)

Light Beer

Other

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

Alcohol free Beer

Other

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

Primary outcomes

  1. 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)

  2. 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

  3. 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

  4. 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)

  5. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Sub-study A : Basal cardiovascular activity : blood pressure

    Time frame: 15 minutes before administration

  9. Sub-study A : Basal cardiovascular activity: heart rate

    Time frame: 15 minutes before administration

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

    Time frame: 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

  11. Sub-study A : Postprandial cardiovascular activity : blood pressure

    Time frame: 1 hour and 2 hours post administration

  12. Sub-study A : Postprandial cardiovascular activity : heart rate

    Time frame: 1 hour and 2 hours post administration

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

    Time frame: 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

  14. Sub-study B : Basal cardiovascular activity : blood pressure

    Time frame: 15 minutes before administration

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

    Time frame: 15 minutes before administration

  16. Sub-study B : Postprandial cardiovascular activity : blood pressure

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

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

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

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

    Time frame: 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.

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

    Time frame: 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.

  20. Sub-study B : Basal isoxanthohumol urinary concentration

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

    Isoxanthohumol is a biomarker of beer consumption.

  21. Sub-study B : Postprandial isoxanthohumol urinary concentration

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

    Isoxanthohumol is a biomarker of beer consumption.

  22. Sub-study B : Basal urinary creatinine concentration

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

  23. Sub-study B : Basal urinary urinary pH.

    Time frame: 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.

  24. 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

  25. Sub-study B : Postprandial urinary urinary pH.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Registry information

Acronym: dopet4

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 3, 2018
Registry last updated
Mar 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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