HealthyPhase 1/2BIOLIVANCT03886597
Nutritional Intervention With Table Olives in Healthy Volunteers
A Phase 1/2 study testing Table Olives in people with Healthy and Biological Availability, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Biological Availability, Nutritional Intervention
- What is being tested?
- Table Olives
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSpain
- Study dates
- 25 Mar 2019to 15 Jun 2019
- Phase
- Phase 1/2
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Institut de Recerca Hospital de la Santa Creu i Sant Pau - CIM Sant Pau
Barcelona, 08041
About this study
Official title: Table Olives Nutritional Intervention: Pharmacokinetics of Polyphenols and Pentacyclic Triterpenes and Assessment of Antioxidant, Cardiovascular and Anti-inflammatory Biomarkers
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
- Healthy, Biological Availability, Nutritional Intervention, Functional Food, Nutrition Physiology
- Being tested
- Table Olives
- Keywords
- Polyphenols, Triterpenes, Olea europaea, Table Olives, Pharmacokinetics, Functional Food, Antioxidant, Cardiovascular Disease, Anti-inflammatory
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Table OlivesOther
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.
Table OlivesOther
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.
Table OlivesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 60 Arbequina Table Olives | Experimental | Pharmacokinetics Study Receives: Other: Table Olives |
| 120 Arbequina Table Olives | Experimental | Pharmacokinetics Study Receives: Other: Table Olives |
| 60 Table Olives | Experimental | Table Olives Nutritional Intervention Receives: Other: Table Olives |
| Control | No intervention | Control of Table Olives Nutritional Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage 1: Maximum plasma concentration (Cmax)
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Measured: 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
Measured: 24 hours
Stage 1: Time until Cmax is reached (Tmax)
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Measured: 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
Measured: 24 hours
Stage 1: AUC extrapolated to infinite time (AUC (0-∞)
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Measured: 24 hours
Stage 1: Percentage of AUC extrapolated (AUC%)
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Measured: 24 hours
Stage 1: Terminal elimination rate constant (Kel)
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Measured: 24 hours
Stage 1: Plasma concentration half-life (t ½)
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Measured: 24 hours
Stage 1: Volume of distribution (Vd/ F)
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Measured: 24 hours
Stage 1: Clearance (Cl/F)
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Measured: 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
Measured: 24 hours
Stage 1: Cmax dose normalized (Cmax/Dose)
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Measured: 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
Measured: 24 hours
Stage 1: Urine polyphenols concentration
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Measured: 24 hours
Stage 1: Urine triterpenes concentration
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Measured: 24 hours
Stage 2: Plasma polyphenols concentration
30 days
Measured: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Plasma triterpenes concentration
30 days
Measured: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Urine polyphenols concentration
30 days
Measured: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Urine triterpenes concentration
30 days
Measured: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Malondialdehyde concentration
30 days
Measured: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Catalase concentration
30 days
Measured: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Glutathione peroxidase concentration
30 days
Measured: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Superoxide dismutase concentration
30 days
Measured: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: F2A isoprostane concentration
30 days
Measured: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: 8 isoprostane concentration
30 days
Measured: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Oxidized low-density lipoprotein concentration
30 days
Measured: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: C-Reactive Protein concentration
30 days
Measured: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Lipoprotein-associated phospholipase A2 concentration
30 days
Measured: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Apolipoprotein A1 concentration
30 days
Measured: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Apolipoprotein B100 concentration
30 days
Measured: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Tumor necrosis factor alpha concentration
30 days
Measured: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Interleukin 6 concentration
30 days
Measured: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Interleukin 1 concentration
30 days
Measured: 30 days dosing period or 30 days as control group separated by 15 days washout
Secondary outcomes (18)
Stage 1 and 2: Number of participants with treatment-related adverse events
30 days
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Triglyceride concentration
30 days
Measured: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Total cholesterol concentration
30 days
Measured: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Sodium concentration
30 days
Measured: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Glucose concentration
30 days
Measured: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Urea concentration
30 days
Measured: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Creatinine concentration
30 days
Measured: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Aspartate aminotransferase concentration
30 days
Measured: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Alanine aminotransferase concentration
30 days
Measured: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Alkaline phosphatase concentration
30 days
Measured: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Total proteins concentration
30 days
Measured: 30 days dosing period or 30 days as control group separated by 15 days washout
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start25 Mar 2019
- Primary completion25 May 2019
- Study completion15 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study involve two stages, the first one corresponding to the pharmacokinetic study of the single administration of table olives in healthy male volunteers and the second one corresponding to the study of a nutritional intervention with 30 table olives during 30 days.
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad (Spain) AGL 2013-41188R, University of Barcelona
- Responsible party
- Sponsor
- Investigators
- Joana M Planas, PhD Prof., Study director, Departament de Bioquímica i Fisiologia. Facultat de Farmàcia i Ciències de l´Alimentació. Universitat de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03886597
- Sponsor's protocol ID
- IIBSP-OLI-2016-23
- Acronym
- BIOLIVA
- Status last verified
- Aug 2019
- First submitted
- 15 Mar 2019
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 26692754Cicerale 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 19093267Covas 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 16954359de 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 17386573Dzubak 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 16741586Ghanbari 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 22489153Juan 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 18298868Kountouri 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 17870451Liu 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 17978478Lou-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 22760979Lozano-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 25093990Madlala 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 26046776Marrugat 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 15168036Martin-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 23450515Melliou 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Table Olives Nutritional Intervention: Pharmacokinetics of Polyphenols and Pentacyclic Triterpenes and Assessment of Antioxidant, Cardiovascular and Anti-inflammatory Biomarkers
- ClinicalTrials.gov ID
- NCT03886597
- Acronym / sponsor ID
- BIOLIVA / IIBSP-OLI-2016-23
- Conditions
- Healthy, Biological Availability, Nutritional Intervention, Functional Food, Nutrition Physiology
- Keywords
- Polyphenols, Triterpenes, Olea europaea, Table Olives, Pharmacokinetics, Functional Food, Antioxidant, Cardiovascular Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad (Spain) AGL 2013-41188R, University of Barcelona
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 25 May 2019 (actual)
- Study completion
- 15 Jun 2019 (actual)
- First posted
- 22 Mar 2019 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This study involve two stages, the first one corresponding to the pharmacokinetic study of the single administration of table olives in healthy male volunteers and the second one corresponding to the study of a nutritional intervention with 30 table olives during 30 days.
| Arm | Type | Receives |
|---|---|---|
| 60 Arbequina Table Olives | Experimental | Other: Table OlivesPharmacokinetics Study |
| 120 Arbequina Table Olives | Experimental | Other: Table OlivesPharmacokinetics Study |
| 60 Table Olives | Experimental | Other: Table OlivesTable Olives Nutritional Intervention |
| Control | No intervention | –Control of Table Olives Nutritional Intervention |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
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 |
|---|---|---|
| Table OlivesAt 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. | Other | 60 Arbequina Table Olives |
| Table OlivesAt 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. | Other | 120 Arbequina Table Olives |
| Table OlivesAll 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. | Other | 60 Table Olives |
Primary outcome
Stage 1: Maximum plasma concentration (Cmax)
Time frame: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 1: Concentration at the end of the dosing interval (Ct)
Time frame: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 1: Time until Cmax is reached (Tmax)
Time frame: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 1: Area under the curve from administration to last observed concentration at time (AUC (0-t)
Time frame: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 1: AUC extrapolated to infinite time (AUC (0-∞)
Time frame: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 1: Percentage of AUC extrapolated (AUC%)
Time frame: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 1: Terminal elimination rate constant (Kel)
Time frame: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 1: Plasma concentration half-life (t ½)
Time frame: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 1: Volume of distribution (Vd/ F)
Time frame: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 1: Clearance (Cl/F)
Time frame: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 1: Peak trough fluctuation over one dosing interval at steady state (PTF)
Time frame: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 1: Cmax dose normalized (Cmax/Dose)
Time frame: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 1: AUC (0-t) dose normalized (AUC (0-t)/Dose)
Time frame: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 1: Urine polyphenols concentration
Time frame: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 1: Urine triterpenes concentration
Time frame: 24 hours
24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 2: Plasma polyphenols concentration
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Stage 2: Plasma triterpenes concentration
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Stage 2: Urine polyphenols concentration
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Stage 2: Urine triterpenes concentration
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Stage 2: Malondialdehyde concentration
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Stage 2: Catalase concentration
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Stage 2: Glutathione peroxidase concentration
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Stage 2: Superoxide dismutase concentration
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Stage 2: F2A isoprostane concentration
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Stage 2: 8 isoprostane concentration
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Stage 2: Oxidized low-density lipoprotein concentration
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Stage 2: C-Reactive Protein concentration
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Stage 2: Lipoprotein-associated phospholipase A2 concentration
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Stage 2: Apolipoprotein A1 concentration
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Stage 2: Apolipoprotein B100 concentration
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Stage 2: Tumor necrosis factor alpha concentration
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Stage 2: Interleukin 6 concentration
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
Stage 2: Interleukin 1 concentration
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
30 days
18 secondary outcomes
Stage 1 and 2: Number of participants with treatment-related adverse events
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
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
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
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
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)
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)
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)
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Triglyceride concentration
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Total cholesterol concentration
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Sodium concentration
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Glucose concentration
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Urea concentration
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Creatinine concentration
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Aspartate aminotransferase concentration
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Alanine aminotransferase concentration
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Alkaline phosphatase concentration
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
Stage 2: Total proteins concentration
Time frame: 30 days dosing period or 30 days as control group separated by 15 days washout
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 8 Aug 2019.
- Background: PubMed 26692754Bachhav 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.
- Background: PubMed 19093267Cicerale 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.
- Background: PubMed 16954359Covas 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.
- Background: PubMed 17386573de 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.
- Background: PubMed 16741586Dzubak 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.
- Background: PubMed 22489153Ghanbari 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.
- Background: PubMed 18298868Juan 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.
- Background: PubMed 17870451Kountouri 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.
- Background: PubMed 17978478Liu 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.
- Background: PubMed 22760979Lou-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.
- Background: PubMed 25093990Lozano-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.
- Background: PubMed 26046776Madlala 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.
- 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.
Joana M Planas, PhD Prof. study director
Departament de Bioquímica i Fisiologia. Facultat de Farmàcia i Ciències de l´Alimentació. Universitat de Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Table Olives in people with Healthy and Biological Availability, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau 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 3 inclusion and 12 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 8 Aug 2019. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Stage 1: Maximum plasma concentration (Cmax) (time frame: 24 hours). The study lists 33 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 NCT03886597, which also lists 20 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 8 Aug 2019.