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

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ClinicalTrials.gov Identifier: NCT03614520
Recruitment Status : Recruiting
First Posted : August 3, 2018
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Rafael de la Torre, 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.

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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.
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 : June 19, 2018
Actual Primary Completion Date : July 3, 2018
Estimated Study Completion Date : December 29, 2019

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)




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03614520


Contacts
Contact: Rafaël de la Torre, Dir. of neurosciences 933160490 ext +34 rtorre@imim.es
Contact: Julian Mateus, Doctor pharmacólogia 933160490 ext +34 jmateus@imim.es

Locations
Spain
Consorci Parc de Salut Mar Recruiting
Barcelona, Spain, 08017
Contact: Julian Mateus, doctor pharmacólogo    933160491 ext +34    jmateus@imim.es   
Sponsors and Collaborators
Parc de Salut Mar

Publications:

Responsible Party: Rafael de la Torre, Director of the Neurosciences Department in IMIM, Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT03614520     History of Changes
Other Study ID Numbers: IMIMFTCL/DOPET4
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs