CompletedNCT03886597BIOLIVAUpdated Aug 8, 2019

Nutritional Intervention With Table Olives in Healthy Volunteers

A Phase 1/2 interventional study of Table Olives and Table Olives in Healthy, Biological Availability and Nutritional Intervention, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Completed at 1 site in Spain. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-08.

Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Phase 1/2, Interventional, and Other

Phase: Phase 1/2
Study type: Interventional
Enrollment: 58
Allocation: Randomized
Ages: 18 Years to 60 Years
Sex: All

Study summary

Olives and olive oil are typical components of the Mediterranean diet being part of its cultural and gastronomic heritage. Since ancient times, olives have been used either for both, oil extraction or whole fruit consumption as table olives. Olive oil stands out from both the nutritional and the health point of view. However, the effect of table olives consumption remains almost unknown. The beneficial properties of olive oil have been initially ascribed to the high concentration of oleic acid. Nowadays, these positive effects have been attributed also to minor compounds such as polyphenols or pentacyclic triterpenes. Table olives contain a higher amount of both polyphenols and pentacyclic triterpenes than their oil, with the same healthy fatty acid profile. Therefore, the present intervention aims at investigating the pharmacokinetic of polyphenols and pentacyclic triterpenes after a single olive intake as well as the assessment of the effect of the consumption of olives during 30 days on the overall health status playing particular attention to the anti-inflammatory, antioxidant and cardiovascular biomarkers.

Conditions studied

Healthy
Biological Availability
Nutritional Intervention
Functional Food
Nutrition Physiology

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Cardiovascular Diseases 5,025

Keywords

Polyphenols
Triterpenes
Olea europaea
Table Olives
Pharmacokinetics
Functional Food
Antioxidant
Cardiovascular Disease
Anti-inflammatory

In context

Cardiovascular Diseases

5,025 studies on the registry are indexed under Cardiovascular Diseases; 930 are open to participants now.

This study's enrollment of 58 is below the median of 100 across 2,801 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 342 studies on the registry; 64 are open to participants now.

Browse Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Body Mass Index between 19 and 30 kg/m2.
Healthy on the basis of physical examination and routine biochemical and hematological laboratory determinations.
Free acceptance to participate in the study by obtains signed informed consent.

Exclusion criteria

Exclusion Criteria:

Smoking.
Alcohol or drug abuse.
Heavy consumer of stimulating beverages (>5 coffees, teas, chocolate or cola drinks per day) and grapefruit juice.
Background of allergy, idiosyncrasy or hypersensitivity to drugs.
Intake of any medication within 2 weeks prior taking the study intervention (except for use of paracetamol in short-term symptomatic treatments), including over-the-counter products (including natural food supplements, vitamins and medicinal plants products), or any enzymatic inductor or inhibitor within 3 months before the drug administration.
Positive serology for hepatitis B, C or HIV.
Background or clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, hematological or neurological disease or other chronic diseases.
Having undergone major surgery during the previous 6 months.
Pregnancy or lactation status (if applied).
Participation in another clinical trial during the 3 months preceding the drug administration.
Donation of blood during the 4 weeks preceding the drug administration.
Acute illness four weeks before drug administration.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 58 participants (actual)

Study arms

Experimental
60 Arbequina Table Olives
Pharmacokinetics Study
Other: Table Olives
Experimental
120 Arbequina Table Olives
Pharmacokinetics Study
Other: Table Olives
Experimental
60 Table Olives
Table Olives Nutritional Intervention
Other: Table Olives
No intervention
Control
Control of Table Olives Nutritional Intervention

Interventions

OtherTable Olives
At early morning (08:00 h e.g.) and after 10 hours of fasting conditions, the olives of the Arbequina variety will be administered to each subject. The 60 olives will be weighted before the ingestion and the remaining stones will be subsequently weighted to keep a record of the amount of olive pulp that has been consumed. The subjects will have a period of 5 minutes to ingest 60 olives with 240 mL of water. Blood samples will be collected from 1 hour prior to administration until 24 hours after dosing. Urine samples will also be collected and blood pressure will be measured.
OtherTable Olives
At early morning (08:00 h e.g.) and after 10 hours of fasting conditions, the olives of the Arbequina variety will be administered to each subject. The 120 olives will be weighted before the ingestion and the remaining stones will be subsequently weighted to keep a record of the amount of olive pulp that has been consumed. The subjects will have a period of 10 minutes to ingest 120 olives with 240 mL of water. Blood samples will be collected from 1 hour prior to administration until 24 hours after dosing. Urine samples will also be collected and blood pressure will be measured.
OtherTable Olives
All the subjects will perform two experimental sessions of 30 days with 15 days of washout periods within experimental periods. In one experimental session subjects will ingest table olives and in the other session they will act as their own controls following their normal dietary habits. During all the experiment participants will avoid the consumption of products rich in phenolic and triterpenic compounds. Subjects will include the dose of 60 table olives within their normal dietary habits. Consequently, the olives will be consumed two times daily within each main meal; 30 olives before lunch and 30 olives before dinner. Blood samples will be collected at baseline and 15 and 30 days of each experimental session. Tolerability variables and blood pressure will also be measured.

What researchers measure

Primary outcomes

Stage 1: Maximum plasma concentration (Cmax)
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Time frame: 24 hours
Stage 1: Concentration at the end of the dosing interval (Ct)
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Time frame: 24 hours
Stage 1: Time until Cmax is reached (Tmax)
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Time frame: 24 hours
Stage 1: Area under the curve from administration to last observed concentration at time (AUC (0-t)
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Time frame: 24 hours
Stage 1: AUC extrapolated to infinite time (AUC (0-∞)
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Time frame: 24 hours
Stage 1: Percentage of AUC extrapolated (AUC%)
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Time frame: 24 hours
Stage 1: Terminal elimination rate constant (Kel)
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Time frame: 24 hours
Stage 1: Plasma concentration half-life (t ½)
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Time frame: 24 hours
Stage 1: Volume of distribution (Vd/ F)
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Time frame: 24 hours
Stage 1: Clearance (Cl/F)
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Time frame: 24 hours
Stage 1: Peak trough fluctuation over one dosing interval at steady state (PTF)
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Time frame: 24 hours
Stage 1: Cmax dose normalized (Cmax/Dose)
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Time frame: 24 hours
Stage 1: AUC (0-t) dose normalized (AUC (0-t)/Dose)
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Time frame: 24 hours
Stage 1: Urine polyphenols concentration
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Time frame: 24 hours
Stage 1: Urine triterpenes concentration
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Time frame: 24 hours
Stage 2: Plasma polyphenols concentration
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Plasma triterpenes concentration
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Urine polyphenols concentration
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Urine triterpenes concentration
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Malondialdehyde concentration
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Catalase concentration
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Glutathione peroxidase concentration
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Superoxide dismutase concentration
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: F2A isoprostane concentration
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: 8 isoprostane concentration
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Oxidized low-density lipoprotein concentration
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: C-Reactive Protein concentration
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Lipoprotein-associated phospholipase A2 concentration
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Apolipoprotein A1 concentration
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Apolipoprotein B100 concentration
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Tumor necrosis factor alpha concentration
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Interleukin 6 concentration
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Interleukin 1 concentration
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout

Secondary outcomes

Stage 1 and 2: Number of participants with treatment-related adverse events
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 1 and 2: Systolic and diastolic blood pressure
Stage 1: 24 hours, Stage 2: 30 days
Time frame: Stage 1: 24 hour dosing period; 2 dosing periods each separated by 7 days washout, Stage 2: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 1 and 2: Heart rate
Stage 1: 24 hours, Stage 2: 30 days
Time frame: Stage 1: 24 hour dosing period; 2 dosing periods each separated by 7 days washout, Stage 2: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 1 and 2: Respiratory rate
Stage 1: 24 hours, Stage 2: 30 days
Time frame: Stage 1: 24 hour dosing period; 2 dosing periods each separated by 7 days washout, Stage 2: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Body weight
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: High-density lipoprotein cholesterol concentration (HDL-C)
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Low-density lipoprotein cholesterol concentration (LDL-C)
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Very low-density lipoprotein cholesterol concentration (VLDL-C)
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Triglyceride concentration
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Total cholesterol concentration
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Sodium concentration
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Glucose concentration
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Urea concentration
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Creatinine concentration
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Aspartate aminotransferase concentration
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Alanine aminotransferase concentration
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Alkaline phosphatase concentration
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Total proteins concentration
30 days
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout

Study locations

1 site

Institut de Recerca Hospital de la Santa Creu i Sant Pau - CIM Sant Pau
Barcelona, 08041, Spain

References and documents

Publications

Bachhav SS, Bhutada MS, Patil SP, Sharma KS, Patil SD. Oleanolic Acid Prevents Increase in Blood Pressure and Nephrotoxicity in Nitric Oxide Dependent Type of Hypertension in Rats. Pharmacognosy Res. 2014 Oct-Dec;7(4):385-92. doi: 10.4103/0974-8490.159575. PubMed 26692754 ↗
Cicerale S, Conlan XA, Sinclair AJ, Keast RS. Chemistry and health of olive oil phenolics. Crit Rev Food Sci Nutr. 2009 Mar;49(3):218-36. doi: 10.1080/10408390701856223. PubMed 19093267 ↗
Covas MI, Nyyssonen K, Poulsen HE, Kaikkonen J, Zunft HJ, Kiesewetter H, Gaddi A, de la Torre R, Mursu J, Baumler H, Nascetti S, Salonen JT, Fito M, Virtanen J, Marrugat J; EUROLIVE Study Group. The effect of polyphenols in olive oil on heart disease risk factors: a randomized trial. Ann Intern Med. 2006 Sep 5;145(5):333-41. doi: 10.7326/0003-4819-145-5-200609050-00006. PubMed 16954359 ↗
de la Torre-Carbot K, Chavez-Servin JL, Jauregui O, Castellote AI, Lamuela-Raventos RM, Fito M, Covas MI, Munoz-Aguayo D, Lopez-Sabater MC. Presence of virgin olive oil phenolic metabolites in human low density lipoprotein fraction: determination by high-performance liquid chromatography-electrospray ionization tandem mass spectrometry. Anal Chim Acta. 2007 Feb 5;583(2):402-10. doi: 10.1016/j.aca.2006.10.029. Epub 2006 Nov 2. PubMed 17386573 ↗
Dzubak P, Hajduch M, Vydra D, Hustova A, Kvasnica M, Biedermann D, Markova L, Urban M, Sarek J. Pharmacological activities of natural triterpenoids and their therapeutic implications. Nat Prod Rep. 2006 Jun;23(3):394-411. doi: 10.1039/b515312n. Epub 2006 May 3. No abstract available. PubMed 16741586 ↗
Ghanbari R, Anwar F, Alkharfy KM, Gilani AH, Saari N. Valuable nutrients and functional bioactives in different parts of olive (Olea europaea L.)-a review. Int J Mol Sci. 2012;13(3):3291-3340. doi: 10.3390/ijms13033291. Epub 2012 Mar 12. PubMed 22489153 ↗
Juan ME, Planas JM, Ruiz-Gutierrez V, Daniel H, Wenzel U. Antiproliferative and apoptosis-inducing effects of maslinic and oleanolic acids, two pentacyclic triterpenes from olives, on HT-29 colon cancer cells. Br J Nutr. 2008 Jul;100(1):36-43. doi: 10.1017/S0007114508882979. Epub 2008 Feb 26. PubMed 18298868 ↗
Kountouri AM, Mylona A, Kaliora AC, Andrikopoulos NK. Bioavailability of the phenolic compounds of the fruits (drupes) of Olea europaea (olives): impact on plasma antioxidant status in humans. Phytomedicine. 2007 Oct;14(10):659-67. doi: 10.1016/j.phymed.2007.06.001. Epub 2007 Sep 17. PubMed 17870451 ↗
Liu J, Sun H, Duan W, Mu D, Zhang L. Maslinic acid reduces blood glucose in KK-Ay mice. Biol Pharm Bull. 2007 Nov;30(11):2075-8. doi: 10.1248/bpb.30.2075. PubMed 17978478 ↗
Lou-Bonafonte JM, Arnal C, Navarro MA, Osada J. Efficacy of bioactive compounds from extra virgin olive oil to modulate atherosclerosis development. Mol Nutr Food Res. 2012 Jul;56(7):1043-57. doi: 10.1002/mnfr.201100668. PubMed 22760979 ↗
Lozano-Mena G, Sanchez-Gonzalez M, Juan ME, Planas JM. Maslinic acid, a natural phytoalexin-type triterpene from olives--a promising nutraceutical? Molecules. 2014 Aug 4;19(8):11538-59. doi: 10.3390/molecules190811538. PubMed 25093990 ↗
Madlala HP, Van Heerden FR, Mubagwa K, Musabayane CT. Changes in Renal Function and Oxidative Status Associated with the Hypotensive Effects of Oleanolic Acid and Related Synthetic Derivatives in Experimental Animals. PLoS One. 2015 Jun 5;10(6):e0128192. doi: 10.1371/journal.pone.0128192. eCollection 2015. PubMed 26046776 ↗
Marrugat J, Covas MI, Fito M, Schroder H, Miro-Casas E, Gimeno E, Lopez-Sabater MC, de la Torre R, Farre M; SOLOS Investigators. Effects of differing phenolic content in dietary olive oils on lipids and LDL oxidation--a randomized controlled trial. Eur J Nutr. 2004 Jun;43(3):140-7. doi: 10.1007/s00394-004-0452-8. Epub 2004 Jan 6. PubMed 15168036 ↗
Martin-Pelaez S, Covas MI, Fito M, Kusar A, Pravst I. Health effects of olive oil polyphenols: recent advances and possibilities for the use of health claims. Mol Nutr Food Res. 2013 May;57(5):760-71. doi: 10.1002/mnfr.201200421. Epub 2013 Mar 1. PubMed 23450515 ↗
Melliou E, Zweigenbaum JA, Mitchell AE. Ultrahigh-pressure liquid chromatography triple-quadrupole tandem mass spectrometry quantitation of polyphenols and secoiridoids in california-style black ripe olives and dry salt-cured olives. J Agric Food Chem. 2015 Mar 11;63(9):2400-5. doi: 10.1021/jf506367e. Epub 2015 Feb 26. PubMed 25668132 ↗
Poudyal H, Campbell F, Brown L. Olive leaf extract attenuates cardiac, hepatic, and metabolic changes in high carbohydrate-, high fat-fed rats. J Nutr. 2010 May;140(5):946-53. doi: 10.3945/jn.109.117812. Epub 2010 Mar 24. PubMed 20335636 ↗
Rodriguez-Rodriguez R, Perona JS, Herrera MD, Ruiz-Gutierrez V. Triterpenic compounds from "orujo" olive oil elicit vasorelaxation in aorta from spontaneously hypertensive rats. J Agric Food Chem. 2006 Mar 22;54(6):2096-102. doi: 10.1021/jf0528512. PubMed 16536581 ↗
Sanchez-Quesada C, Lopez-Biedma A, Warleta F, Campos M, Beltran G, Gaforio JJ. Bioactive properties of the main triterpenes found in olives, virgin olive oil, and leaves of Olea europaea. J Agric Food Chem. 2013 Dec 18;61(50):12173-82. doi: 10.1021/jf403154e. Epub 2013 Nov 22. PubMed 24279741 ↗
Uylaser V, Yildiz G. The historical development and nutritional importance of olive and olive oil constituted an important part of the Mediterranean diet. Crit Rev Food Sci Nutr. 2014;54(8):1092-101. doi: 10.1080/10408398.2011.626874. PubMed 24499124 ↗
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. PubMed 15333722 ↗

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2019 to primary completion in May 2019, 2 months.

How these figures are worked out, and which studies are left out of them.

Registered: Mar 15, 2019
First posted: Mar 22, 2019
StartActual: Mar 25, 2019
Primary completionActual: May 25, 2019
CompletionActual: Jun 15, 2019
Last update: Aug 8, 2019

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Aug 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03886597
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators: Ministerio de Economía y Competitividad (Spain) AGL 2013-41188R, University of Barcelona
Responsible party: Sponsor
First posted: Mar 22, 2019
Start date: Mar 25, 2019
Primary completion: May 25, 2019
Completion: Jun 15, 2019
Last update: Aug 8, 2019

Study contacts

Joana M Planas, PhD Prof.

study director · Departament de Bioquímica i Fisiologia. Facultat de Farmàcia i Ciències de l´Alimentació. Universitat de Barcelona

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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