Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-03-04 @ 9:58 PM
Study NCT ID:
NCT03614520
Status:
COMPLETED
Last Update Posted:
2020-03-05
First Post:
2018-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Bioavailability and Metabolism of Diet Phenolic Compounds
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069463', 'term': 'Olive Oil'}, {'id': 'D014867', 'term': 'Water'}, {'id': 'D000431', 'term': 'Ethanol'}], 'ancestors': [{'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': '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).'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'A 40 people group of healthy men and women. Two Cohorts group of 20 healthy volunteers of both genders.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-04', 'studyFirstSubmitDate': '2018-07-10', 'studyFirstSubmitQcDate': '2018-08-02', 'lastUpdatePostDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}], 'secondaryOutcomes': [{'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', 'description': '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'}, {'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', 'description': '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'}, {'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', 'description': '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.'}, {'measure': 'Sub-study B : Postprandial Concentration of alcohol in the exhaled breath', 'timeFrame': '30 minutes, 1hour, 2 hours and 4 hours post administration', 'description': '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.'}, {'measure': 'Sub-study B : Basal isoxanthohumol urinary concentration', 'timeFrame': '2 hours before administration to administration (-2 to 0 hours)', 'description': 'Isoxanthohumol is a biomarker of beer consumption.'}, {'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', 'description': 'Isoxanthohumol is a biomarker of beer consumption.'}, {'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)', 'description': 'pH is a logarithmic scale used to specify the acidity or basicity of an aqueous solution.'}, {'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', 'description': 'pH is a logarithmic scale used to specify the acidity or basicity of an aqueous solution.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '28112268', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '27664690', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25712532', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20416016', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23642776', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '15333722', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22440854', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25060792', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '17684203', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16286173', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28446500', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'The study is divided in two sub-studies to explore each objective.\n\nOne 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.\n\nOne 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.\n\nAt different times after the administration of drinks, urine and blood samples will be collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women from 18 to 45 years old.\n* Understand and accepting the procedures of the trial and sign an informed consent.\n* Have a history and physical exams that show that there is no organic issue, and an analysis and ECG in the normal limits.\n* Have an BMI between 18.5 and 30 kg/m2.\n* caucasian race\n\nExclusion Criteria:\n\n* Smokers\n* Persons with chronical disease\n* Persons with BMI\\>30 or \\<18.5 kg/m2.\n* 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.\n* Persons who take anti-oxidant products, including vitamins, herbal medication or dietetics complementation that could interfere in the study objectives.\n* Persons with restrictive diet (including vegetarian diet).\n* Persons with history of hypersensibility or intolerance to alcohol.\n* Persons with a daily consumption of alcohol \\>50g or who have consumed illegal drug in the month preceding the study.\n* Persons who have participated in an other clinical trial the month preceding the study.\n* 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).\n* Persons who have a positive serology for B or C hepatitis or HIV.\n* Pregnant or breastfeeding women, or any other situation prohibiting alcohol consumption.\n* Persons who have consummed NSAIDs (especially acetylsalicylic acid) or antioxidants or vitamin complementation, during the 2 weeks preceding the beginning of the study.\n* Illiterate persons'}, 'identificationModule': {'nctId': 'NCT03614520', 'acronym': 'dopet4', 'briefTitle': 'Evaluation of Bioavailability and Metabolism of Diet Phenolic Compounds', 'organization': {'class': 'OTHER', 'fullName': 'Parc de Salut Mar'}, 'officialTitle': 'Evaluation of Bioavailability and Metabolism of Diet Phenolic Compounds', 'orgStudyIdInfo': {'id': 'IMIMFTCL/DOPET4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sub-study A : olive oil, wine, both, or water (placebo).', '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.', 'interventionNames': ['Other: Administration of olive oil', 'Other: Administration of red wine', 'Other: Combination of red wine and olive oil', 'Other: Water']}, {'type': 'EXPERIMENTAL', 'label': 'Sub-study B : three types of beer, and wine', '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.', 'interventionNames': ['Other: Administration of red wine', 'Other: Dark beer', 'Other: Light Beer', 'Other: Alcohol free Beer']}], 'interventions': [{'name': 'Administration of olive oil', 'type': 'OTHER', 'description': '25 mL of extra virgin olive oil', 'armGroupLabels': ['Sub-study A : olive oil, wine, both, or water (placebo).']}, {'name': 'Administration of red wine', 'type': 'OTHER', 'description': '150 mL or Red Wine', 'armGroupLabels': ['Sub-study A : olive oil, wine, both, or water (placebo).', 'Sub-study B : three types of beer, and wine']}, {'name': 'Combination of red wine and olive oil', 'type': 'OTHER', 'description': '150 mL of Red wine + 25 mL of Extra Virgin Olive oil will be administred at the same time', 'armGroupLabels': ['Sub-study A : olive oil, wine, both, or water (placebo).']}, {'name': 'Water', 'type': 'OTHER', 'description': 'Mineral water will be given as placebo', 'armGroupLabels': ['Sub-study A : olive oil, wine, both, or water (placebo).']}, {'name': 'Dark beer', 'type': 'OTHER', 'description': '250 mL of IPA beer (alcohol 8.5% vol)', 'armGroupLabels': ['Sub-study B : three types of beer, and wine']}, {'name': 'Light Beer', 'type': 'OTHER', 'description': '250 mL of blonde ale beer (alcohol 4,5% vol)', 'armGroupLabels': ['Sub-study B : three types of beer, and wine']}, {'name': 'Alcohol free Beer', 'type': 'OTHER', 'description': '250 mL of alcohol free beer (alcohol 0.0% vol)', 'armGroupLabels': ['Sub-study B : three types of beer, and wine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08017', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Consorci Parc de Salut Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Rafael de la Torre Fornell, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IMIM (Hospital del Mar Medical Research Institute)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Parc de Salut Mar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the Neurosciences Department in IMIM', 'investigatorFullName': 'Rafael de la Torre', 'investigatorAffiliation': 'Parc de Salut Mar'}}}}