HealthyPhase 1dopet4NCT03614520
Evaluation of Bioavailability and Metabolism of Diet Phenolic Compounds
A Phase 1 study testing Administration of olive oil, Administration of red wine and Combination of red wine and olive oil in people with Healthy, run by Parc de Salut Mar at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Administration of olive oil, Administration of red wine and Combination of red wine and olive oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 9 Jul 2018to 27 Feb 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of olive oilOther
25 mL of extra virgin olive oil
Administration of red wineOther
150 mL or Red Wine
Combination of red wine and olive oilOther
150 mL of Red wine + 25 mL of Extra Virgin Olive oil will be administred at the same time
WaterOther
Mineral water will be given as placebo
Dark beerOther
250 mL of IPA beer (alcohol 8.5% vol)
Light BeerOther
250 mL of blonde ale beer (alcohol 4,5% vol)
Alcohol free BeerOther
250 mL of alcohol free beer (alcohol 0.0% vol)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Administration of red wine; Other: Dark beer; Other: Light Beer; Other: Alcohol free Beer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sub-study A : Basal dosing of urinary phenolic compounds and their metabolites concentrations
Measured: 2 hours before administration to administration (-2 to 0 hours)
Sub-study A : Basal dosing of urinary phenolic compounds and their metabolites concentrations
Measured: 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
Measured: 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
Measured: 2 hours before administration to administration (-2 to 0 hours)
Sub-study B : Postprandial dosing of urinary phenolic compounds and their metabolites concentrations
Measured: 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
Measured: baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration
Sub-study A : Postprandial dosing of plasmatic insulin
Measured: 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
Measured: baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration
Sub-study A : Postprandial dosing of plasmatic triglyceride
Measured: baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration
Sub-study A : Postprandial dosing of plasmatic LDL
Measured: baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration
Sub-study A : Postprandial dosing of plasmatic oxidated-LDL
Measured: baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration
Sub-study A : Postprandial dosing of plasmatic HDL concentrations.
Measured: baseline, 30 minutes; 45 minutes; 1 hours; 1.5 hours; 2 hours; 6 hours post administration
Sub-study A : Basal cardiovascular activity : blood pressure
Measured: 15 minutes before administration
Sub-study A : Basal cardiovascular activity: heart rate
Measured: 15 minutes before administration
Sub-study A : Basal cardiovascular activity : endothelial function.
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
Measured: 15 minutes before administration
Sub-study A : Postprandial cardiovascular activity : blood pressure
Measured: 1 hour and 2 hours post administration
Sub-study A : Postprandial cardiovascular activity : heart rate
Measured: 1 hour and 2 hours post administration
Sub-study A : Postprandial cardiovascular activity: endothelial function.
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
Measured: 1 hour and 2 hours post administration
Sub-study B : Basal cardiovascular activity : blood pressure
Measured: 15 minutes before administration
Sub-study B : Basal cardiovascular activity: heart rate.
Measured: 15 minutes before administration
Sub-study B : Postprandial cardiovascular activity : blood pressure
Measured: 30 minutes, 1hour, 2 hours and 4 hours post administration
Sub-study B : Postprandial cardiovascular activity: heart rate.
Measured: 30 minutes, 1hour, 2 hours and 4 hours post administration
Sub-study B : Concentration of alcohol in the exhaled breath
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.
Measured: 15 minutes before administration
Sub-study B : Postprandial Concentration of alcohol in the exhaled breath
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.
Measured: 30 minutes, 1hour, 2 hours and 4 hours post administration
Sub-study B : Basal isoxanthohumol urinary concentration
Isoxanthohumol is a biomarker of beer consumption.
Measured: 2 hours before administration to administration (-2 to 0 hours)
Sub-study B : Postprandial isoxanthohumol urinary concentration
Isoxanthohumol is a biomarker of beer consumption.
Measured: 0-2 hours; 2-4 hours; 4-6 hours; 6-12 hours; 12-24 hours post administration
Sub-study B : Basal urinary creatinine concentration
Measured: 2 hours before administration to administration (-2 to 0 hours)
Sub-study B : Basal urinary urinary pH.
pH is a logarithmic scale used to specify the acidity or basicity of an aqueous solution.
Measured: 2 hours before administration to administration (-2 to 0 hours)
Sub-study B : Postprandial urinary creatinine concentration
Measured: 0-2 hours; 2-4 hours; 4-6 hours; 6-12 hours; 12-24 hours post administration
Sub-study B : Postprandial urinary urinary pH.
pH is a logarithmic scale used to specify the acidity or basicity of an aqueous solution.
Measured: 0-2 hours; 2-4 hours; 4-6 hours; 6-12 hours; 12-24 hours post administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start9 Jul 2018
- Primary completion27 Feb 2019
- Study completion27 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafael de la Torre, Parc de Salut Mar
- Investigators
- Rafael de la Torre Fornell, Dr, Principal investigator, IMIM (Hospital del Mar Medical Research Institute)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614520
- Sponsor's protocol ID
- IMIMFTCL/DOPET4
- Acronym
- dopet4
- Status last verified
- Mar 2020
- First submitted
- 10 Jul 2018
- Last updated
- 5 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28112268Rodriguez-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.
PubMed 27664690Perez-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.
PubMed 25712532Granados-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.
PubMed 20416016Oliveras-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.
PubMed 23642776Weinbrenner 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.
PubMed 15333722Castaner 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.
PubMed 22440854Hernaez 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.
PubMed 25060792Ruano 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.
PubMed 17684203Ruano 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.
PubMed 16286173De 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.
PubMed 28446500
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bioavailability and Metabolism of Diet Phenolic Compounds
- ClinicalTrials.gov ID
- NCT03614520
- Acronym / sponsor ID
- dopet4 / IMIMFTCL/DOPET4
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 27 Feb 2019 (actual)
- Study completion
- 27 Feb 2019 (actual)
- First posted
- 3 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A 40 people group of healthy men and women. Two Cohorts group of 20 healthy volunteers of both genders.
| Arm | Type | Receives |
|---|---|---|
| Sub-study A : olive oil, wine, both, or water (placebo). | Experimental | Other: Administration of olive oil, Other: Administration of red wine, Other: Combination of red wine and olive oil, Other: WaterAfter 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. |
| Sub-study B : three types of beer, and wine | Experimental | Other: Administration of red wine, Other: Dark beer, Other: Light Beer, Other: Alcohol free BeerThe 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of olive oil25 mL of extra virgin olive oil | Other | Sub-study A : olive oil, wine, both, or water (placebo). |
| Administration of red wine150 mL or Red Wine | Other | 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 oil150 mL of Red wine + 25 mL of Extra Virgin Olive oil will be administred at the same time | Other | Sub-study A : olive oil, wine, both, or water (placebo). |
| WaterMineral water will be given as placebo | Other | Sub-study A : olive oil, wine, both, or water (placebo). |
| Dark beer250 mL of IPA beer (alcohol 8.5% vol) | Other | Sub-study B : three types of beer, and wine |
| Light Beer250 mL of blonde ale beer (alcohol 4,5% vol) | Other | Sub-study B : three types of beer, and wine |
| Alcohol free Beer250 mL of alcohol free beer (alcohol 0.0% vol) | Other | Sub-study B : three types of beer, and wine |
Primary outcome
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)
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
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
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)
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
25 secondary outcomes
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
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
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
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
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
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
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
Sub-study A : Basal cardiovascular activity : blood pressure
Time frame: 15 minutes before administration
Sub-study A : Basal cardiovascular activity: heart rate
Time frame: 15 minutes before administration
Sub-study A : Basal cardiovascular activity : endothelial function.
Time frame: 15 minutes before administration
Sub-study A : Postprandial cardiovascular activity : blood pressure
Time frame: 1 hour and 2 hours post administration
Sub-study A : Postprandial cardiovascular activity : heart rate
Time frame: 1 hour and 2 hours post administration
Sub-study A : Postprandial cardiovascular activity: endothelial function.
Time frame: 1 hour and 2 hours post administration
Sub-study B : Basal cardiovascular activity : blood pressure
Time frame: 15 minutes before administration
Sub-study B : Basal cardiovascular activity: heart rate.
Time frame: 15 minutes before administration
Sub-study B : Postprandial cardiovascular activity : blood pressure
Time frame: 30 minutes, 1hour, 2 hours and 4 hours post administration
Sub-study B : Postprandial cardiovascular activity: heart rate.
Time frame: 30 minutes, 1hour, 2 hours and 4 hours post administration
Sub-study B : Concentration of alcohol in the exhaled breath
Time frame: 15 minutes before administration
Sub-study B : Postprandial Concentration of alcohol in the exhaled breath
Time frame: 30 minutes, 1hour, 2 hours and 4 hours post administration
Sub-study B : Basal isoxanthohumol urinary concentration
Time frame: 2 hours before administration to administration (-2 to 0 hours)
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
Sub-study B : Basal urinary creatinine concentration
Time frame: 2 hours before administration to administration (-2 to 0 hours)
Sub-study B : Basal urinary urinary pH.
Time frame: 2 hours before administration to administration (-2 to 0 hours)
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
- Background: PubMed 28112268Wu 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.
- Background: PubMed 27664690Rodriguez-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.
- Background: PubMed 25712532Perez-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.
- Background: PubMed 20416016Granados-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.
- Background: PubMed 23642776Oliveras-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.
- Background: PubMed 15333722Weinbrenner 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.
- Background: PubMed 22440854Castaner 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.
- Background: PubMed 25060792Hernaez 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.
- Background: PubMed 17684203Ruano 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.
- Background: PubMed 16286173Ruano 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.
- Background: PubMed 28446500De 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafael de la Torre Fornell, Dr principal investigator
IMIM (Hospital del Mar Medical Research Institute)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Administration of olive oil, Administration of red wine and Combination of red wine and olive oil in people with Healthy, run by Parc de Salut Mar at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03614520, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2020.