Evaluation of Bioavailability and Metabolism of Diet Phenolic Compounds

NCT03614520 | Completed Phase 1

• 1 other identifier: IMIMFTCL/DOPET4
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Sub-study A : Basal dosing of urinary phenolic compounds and their metabolites concentrations

  2 hours before administration to administration (-2 to 0 hours)

• Sub-study A : Basal dosing of urinary phenolic compounds and their metabolites concentrations

  0-2 hours; 2-4 hours; 4-6 hours; 6-12 hours; 12-24 hours post administration

• Sub-study A : Postprandial dosing of plasmatic phenolic compounds and their metabolites concentrations

  baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration

• Sub-study B : Basal dosing of urinary phenolic compounds and their metabolites concentrations

  2 hours before administration to administration (-2 to 0 hours)

• Sub-study B : Postprandial dosing of urinary phenolic compounds and their metabolites concentrations

  0-2 hours; 2-4 hours; 4-6 hours; 6-12 hours; 12-24 hours

Secondary Outcomes (25)

• Sub-study A : Postprandial dosing of plasmatic glucose

  baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration

• Sub-study A : Postprandial dosing of plasmatic insulin

  baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration

• Sub-study A : Postprandial dosing of plasmatic total cholesterol

  baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration

• Sub-study A : Postprandial dosing of plasmatic triglyceride

  baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration

• Sub-study A : Postprandial dosing of plasmatic LDL

  baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration

Study Arms (2)

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

EXPERIMENTAL

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; Other: Administration of red wine; Other: Combination of red wine and olive oil; Other: Water

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

EXPERIMENTAL

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; Other: Dark beer; Other: Light Beer; Other: Alcohol free Beer

Interventions

Administration of olive oil OTHER

25 mL of extra virgin olive oil

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

Administration of red wine OTHER

150 mL or Red Wine

Sub-study A : olive oil, wine, both, or water (placebo).; Sub-study B : three types of beer, and 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

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

Water OTHER

Mineral water will be given as placebo

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

Dark beer OTHER

250 mL of IPA beer (alcohol 8.5% vol)

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

Light Beer OTHER

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

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

Alcohol free Beer OTHER

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

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Consorci Parc de Salut Mar

Barcelona, 08017, Spain

Location

Related Publications (11)

• 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: 28112268 BACKGROUND

• 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: 27664690 BACKGROUND

• 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: 25712532 BACKGROUND

• 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: 20416016 BACKGROUND

• 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: 23642776 BACKGROUND

• 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: 15333722 BACKGROUND

• 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: 22440854 BACKGROUND

• 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: 25060792 BACKGROUND

• 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: 17684203 BACKGROUND

• 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: 16286173 BACKGROUND

• 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.

  PMID: 28446500 BACKGROUND

MeSH Terms

Interventions

Olive Oil; Water; Ethanol

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Alcohols; Organic Chemicals

Study Officials

• Rafael de la Torre Fornell, Dr

  IMIM (Hospital del Mar Medical Research Institute)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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).
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Neurosciences Department in IMIM

Model Details: A 40 people group of healthy men and women. Two Cohorts group of 20 healthy volunteers of both genders.

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: August 3, 2018
• Study Start: July 9, 2018
• Primary Completion: February 27, 2019
• Study Completion: February 27, 2019
• Last Updated: March 5, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)