Nutritional Intervention With Table Olives in Healthy Volunteers (BIOLIVA)
August 7, 2019 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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.
Study Overview
Status
Status
Completed
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Interventional
Enrollment (Actual)
Enrollment
58
Phase
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Barcelona, Spain, 08041
- Institut de Recerca Hospital de la Santa Creu i Sant Pau - CIM Sant Pau
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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:
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Number of Arms
4
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
EXPERIMENTAL: 60 Arbequina Table Olives
Pharmacokinetics Study
|
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.
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.
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.
|
|
EXPERIMENTAL: 120 Arbequina Table Olives
Pharmacokinetics Study
|
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.
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.
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.
|
|
EXPERIMENTAL: 60 Table Olives
Table Olives Nutritional Intervention
|
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.
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.
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.
|
|
NO_INTERVENTION: Control
Control of Table Olives Nutritional Intervention
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stage 1: Maximum plasma concentration (Cmax)
Time Frame: 24 hours
|
24 hour dosing period; 2 dosing periods each separated by 7 days washout
|
24 hours
|
|
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
|
24 hours
|
|
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
|
24 hours
|
|
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
|
24 hours
|
|
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
|
24 hours
|
|
Stage 1: Percentage of AUC extrapolated (AUC%)
Time Frame: 24 hours
|
24 hour dosing period; 2 dosing periods each separated by 7 days washout
|
24 hours
|
|
Stage 1: Terminal elimination rate constant (Kel)
Time Frame: 24 hours
|
24 hour dosing period; 2 dosing periods each separated by 7 days washout
|
24 hours
|
|
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
|
24 hours
|
|
Stage 1: Volume of distribution (Vd/ F)
Time Frame: 24 hours
|
24 hour dosing period; 2 dosing periods each separated by 7 days washout
|
24 hours
|
|
Stage 1: Clearance (Cl/F)
Time Frame: 24 hours
|
24 hour dosing period; 2 dosing periods each separated by 7 days washout
|
24 hours
|
|
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
|
24 hours
|
|
Stage 1: Cmax dose normalized (Cmax/Dose)
Time Frame: 24 hours
|
24 hour dosing period; 2 dosing periods each separated by 7 days washout
|
24 hours
|
|
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
|
24 hours
|
|
Stage 1: Urine polyphenols concentration
Time Frame: 24 hours
|
24 hour dosing period; 2 dosing periods each separated by 7 days washout
|
24 hours
|
|
Stage 1: Urine triterpenes concentration
Time Frame: 24 hours
|
24 hour dosing period; 2 dosing periods each separated by 7 days washout
|
24 hours
|
|
Stage 2: Plasma polyphenols concentration
Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout
|
30 days
|
30 days dosing period or 30 days as control group separated by 15 days washout
|
|
Stage 2: Plasma triterpenes concentration
Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout
|
30 days
|
30 days dosing period or 30 days as control group separated by 15 days washout
|
|
Stage 2: Urine polyphenols concentration
Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout
|
30 days
|
30 days dosing period or 30 days as control group separated by 15 days washout
|
|
Stage 2: Urine triterpenes concentration
Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout
|
30 days
|
30 days dosing period or 30 days as control group separated by 15 days washout
|
|
Stage 2: Malondialdehyde concentration
Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout
|
30 days
|
30 days dosing period or 30 days as control group separated by 15 days washout
|
|
Stage 2: Catalase concentration
Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout
|
30 days
|
30 days dosing period or 30 days as control group separated by 15 days washout
|
|
Stage 2: Glutathione peroxidase concentration
Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout
|
30 days
|
30 days dosing period or 30 days as control group separated by 15 days washout
|
|
Stage 2: Superoxide dismutase concentration
Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout
|
30 days
|
30 days dosing period or 30 days as control group separated by 15 days washout
|
|
Stage 2: F2A isoprostane concentration
Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout
|
30 days
|
30 days dosing period or 30 days as control group separated by 15 days washout
|
|
Stage 2: 8 isoprostane concentration
Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout
|
30 days
|
30 days dosing period or 30 days as control group separated by 15 days washout
|
|
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
|
30 days dosing period or 30 days as control group separated by 15 days washout
|
|
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
|
30 days dosing period or 30 days as control group separated by 15 days washout
|
|
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
|
30 days dosing period or 30 days as control group separated by 15 days washout
|
|
Stage 2: Apolipoprotein A1 concentration
Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout
|
30 days
|
30 days dosing period or 30 days as control group separated by 15 days washout
|
|
Stage 2: Apolipoprotein B100 concentration
Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout
|
30 days
|
30 days dosing period or 30 days as control group separated by 15 days washout
|
|
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
|
30 days dosing period or 30 days as control group separated by 15 days washout
|
|
Stage 2: Interleukin 6 concentration
Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout
|
30 days
|
30 days dosing period or 30 days as control group separated by 15 days washout
|
|
Stage 2: Interleukin 1 concentration
Time Frame: 30 days dosing period or 30 days as control group separated by 15 days washout
|
30 days
|
30 days dosing period or 30 days as control group separated by 15 days washout
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
30 days
|
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: 24 hours, Stage 2: 30 days
|
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: 24 hours, Stage 2: 30 days
|
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 1: 24 hours, Stage 2: 30 days
|
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
|
30 days
|
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
|
30 days
|
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
|
30 days
|
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
|
30 days
|
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
|
30 days
|
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
|
30 days
|
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
|
30 days
|
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
|
30 days
|
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
|
30 days
|
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
|
30 days
|
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
|
30 days
|
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
|
30 days
|
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
|
30 days
|
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
|
30 days
|
30 days dosing period or 30 days as control group separated by 15 days washout
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Study Director: Joana M Planas, PhD Prof., Departament de Bioquímica i Fisiologia. Facultat de Farmàcia i Ciències de l´Alimentació. Universitat de Barcelona
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
Study Start
March 25, 2019
Primary Completion (ACTUAL)
Primary Completion
May 25, 2019
Study Completion (ACTUAL)
Study Completion
June 15, 2019
Study Registration Dates
First Submitted
First Submitted
March 15, 2019
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
March 20, 2019
First Posted (ACTUAL)
First Posted
March 22, 2019
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Posted
August 8, 2019
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
August 7, 2019
Last Verified
Last Verified
August 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
Other Study ID Numbers
- IIBSP-OLI-2016-23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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