Evaluation of Bioavailability and Metabolism of Diet Phenolic Compounds
NCT ID: NCT03614520
Last Updated: 2020-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2018-07-09
2019-02-27
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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.
Administration of olive oil
25 mL of extra virgin olive oil
Administration of red wine
150 mL or Red Wine
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
Water
Mineral water will be given as placebo
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.
Administration of red wine
150 mL or Red Wine
Dark beer
250 mL of IPA beer (alcohol 8.5% vol)
Light Beer
250 mL of blonde ale beer (alcohol 4,5% vol)
Alcohol free Beer
250 mL of alcohol free beer (alcohol 0.0% vol)
Interventions
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Administration of olive oil
25 mL of extra virgin olive oil
Administration of red wine
150 mL or Red Wine
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
Water
Mineral water will be given as placebo
Dark beer
250 mL of IPA beer (alcohol 8.5% vol)
Light Beer
250 mL of blonde ale beer (alcohol 4,5% vol)
Alcohol free Beer
250 mL of alcohol free beer (alcohol 0.0% vol)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
45 Years
ALL
Yes
Sponsors
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Parc de Salut Mar
OTHER
Responsible Party
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Rafael de la Torre
Director of the Neurosciences Department in IMIM
Principal Investigators
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Rafael de la Torre Fornell, Dr
Role: PRINCIPAL_INVESTIGATOR
IMIM (Hospital del Mar Medical Research Institute)
Locations
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Consorci Parc de Salut Mar
Barcelona, , Spain
Countries
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References
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Wu L, Sun D. Adherence to Mediterranean diet and risk of developing cognitive disorders: An updated systematic review and meta-analysis of prospective cohort studies. Sci Rep. 2017 Jan 23;7:41317. doi: 10.1038/srep41317.
Rodriguez-Morato J, Robledo P, Tanner JA, Boronat A, Perez-Mana C, Oliver Chen CY, Tyndale RF, de la Torre R. CYP2D6 and CYP2A6 biotransform dietary tyrosol into hydroxytyrosol. Food Chem. 2017 Feb 15;217:716-725. doi: 10.1016/j.foodchem.2016.09.026. Epub 2016 Sep 7.
Perez-Mana C, Farre M, Rodriguez-Morato J, Papaseit E, Pujadas M, Fito M, Robledo P, Covas MI, Cheynier V, Meudec E, Escudier JL, de la Torre R. Moderate consumption of wine, through both its phenolic compounds and alcohol content, promotes hydroxytyrosol endogenous generation in humans. A randomized controlled trial. Mol Nutr Food Res. 2015 Jun;59(6):1213-6. doi: 10.1002/mnfr.201400842. Epub 2015 Apr 27.
Granados-Principal S, Quiles JL, Ramirez-Tortosa CL, Sanchez-Rovira P, Ramirez-Tortosa MC. Hydroxytyrosol: from laboratory investigations to future clinical trials. Nutr Rev. 2010 Apr;68(4):191-206. doi: 10.1111/j.1753-4887.2010.00278.x.
Oliveras-Lopez MJ, Molina JJ, Mir MV, Rey EF, Martin F, de la Serrana HL. Extra virgin olive oil (EVOO) consumption and antioxidant status in healthy institutionalized elderly humans. Arch Gerontol Geriatr. 2013 Sep-Oct;57(2):234-42. doi: 10.1016/j.archger.2013.04.002. Epub 2013 May 1.
Weinbrenner T, Fito M, de la Torre R, Saez GT, Rijken P, Tormos C, Coolen S, Albaladejo MF, Abanades S, Schroder H, Marrugat J, Covas MI. Olive oils high in phenolic compounds modulate oxidative/antioxidative status in men. J Nutr. 2004 Sep;134(9):2314-21. doi: 10.1093/jn/134.9.2314.
Castaner O, Covas MI, Khymenets O, Nyyssonen K, Konstantinidou V, Zunft HF, de la Torre R, Munoz-Aguayo D, Vila J, Fito M. Protection of LDL from oxidation by olive oil polyphenols is associated with a downregulation of CD40-ligand expression and its downstream products in vivo in humans. Am J Clin Nutr. 2012 May;95(5):1238-44. doi: 10.3945/ajcn.111.029207. Epub 2012 Mar 21.
Hernaez A, Fernandez-Castillejo S, Farras M, Catalan U, Subirana I, Montes R, Sola R, Munoz-Aguayo D, Gelabert-Gorgues A, Diaz-Gil O, Nyyssonen K, Zunft HJ, de la Torre R, Martin-Pelaez S, Pedret A, Remaley AT, Covas MI, Fito M. Olive oil polyphenols enhance high-density lipoprotein function in humans: a randomized controlled trial. Arterioscler Thromb Vasc Biol. 2014 Sep;34(9):2115-9. doi: 10.1161/ATVBAHA.114.303374. Epub 2014 Jul 24.
Ruano J, Lopez-Miranda J, de la Torre R, Delgado-Lista J, Fernandez J, Caballero J, Covas MI, Jimenez Y, Perez-Martinez P, Marin C, Fuentes F, Perez-Jimenez F. Intake of phenol-rich virgin olive oil improves the postprandial prothrombotic profile in hypercholesterolemic patients. Am J Clin Nutr. 2007 Aug;86(2):341-6. doi: 10.1093/ajcn/86.2.341.
Ruano J, Lopez-Miranda J, Fuentes F, Moreno JA, Bellido C, Perez-Martinez P, Lozano A, Gomez P, Jimenez Y, Perez Jimenez F. Phenolic content of virgin olive oil improves ischemic reactive hyperemia in hypercholesterolemic patients. J Am Coll Cardiol. 2005 Nov 15;46(10):1864-8. doi: 10.1016/j.jacc.2005.06.078. Epub 2005 Oct 24.
De la Torre R, Corella D, Castaner O, Martinez-Gonzalez MA, Salas-Salvado J, Vila J, Estruch R, Sorli JV, Aros F, Fiol M, Ros E, Serra-Majem L, Pinto X, Gomez-Gracia E, Lapetra J, Ruiz-Canela M, Basora J, Asensio EM, Covas MI, Fito M. Protective effect of homovanillyl alcohol on cardiovascular disease and total mortality: virgin olive oil, wine, and catechol-methylation. Am J Clin Nutr. 2017 Jun;105(6):1297-1304. doi: 10.3945/ajcn.116.145813. Epub 2017 Apr 26.
Other Identifiers
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IMIMFTCL/DOPET4
Identifier Type: -
Identifier Source: org_study_id
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