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| Name | Class |
|---|---|
| Ministerio de EconomÃa y Competitividad (Spain) AGL 2013-41188R | UNKNOWN |
| University of Barcelona | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 60 Arbequina Table Olives | Experimental | Pharmacokinetics Study |
|
| 120 Arbequina Table Olives | Experimental | Pharmacokinetics Study |
|
| 60 Table Olives | Experimental | Table Olives Nutritional Intervention |
|
| Control | No Intervention | Control of Table Olives Nutritional Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Table Olives | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Stage 1: Maximum plasma concentration (Cmax) | 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) | 24 hour dosing period; 2 dosing periods each separated by 7 days washout | 24 hours |
| Stage 1: Time until Cmax is reached (Tmax) | 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) | 24 hour dosing period; 2 dosing periods each separated by 7 days washout | 24 hours |
| Stage 1: AUC extrapolated to infinite time (AUC (0-∞) | 24 hour dosing period; 2 dosing periods each separated by 7 days washout | 24 hours |
| Stage 1: Percentage of AUC extrapolated (AUC%) | 24 hour dosing period; 2 dosing periods each separated by 7 days washout | 24 hours |
| Stage 1: Terminal elimination rate constant (Kel) | 24 hour dosing period; 2 dosing periods each separated by 7 days washout | 24 hours |
| Stage 1: Plasma concentration half-life (t ½) |
| Measure | Description | Time Frame |
|---|---|---|
| Stage 1 and 2: Number of participants with treatment-related adverse events | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joana M Planas, PhD Prof. | Departament de BioquÃmica i Fisiologia. Facultat de Farmà cia i Ciències de l´Alimentació. Universitat de Barcelona | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Recerca Hospital de la Santa Creu i Sant Pau - CIM Sant Pau | Barcelona | 08041 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26692754 | Background | 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. | |
| 19093267 | Background | 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. |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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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.
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|
| Table Olives | Other | 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 Olives | Other | 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. |
|
24 hour dosing period; 2 dosing periods each separated by 7 days washout |
| 24 hours |
| Stage 1: Volume of distribution (Vd/ F) | 24 hour dosing period; 2 dosing periods each separated by 7 days washout | 24 hours |
| Stage 1: Clearance (Cl/F) | 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) | 24 hour dosing period; 2 dosing periods each separated by 7 days washout | 24 hours |
| Stage 1: Cmax dose normalized (Cmax/Dose) | 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) | 24 hour dosing period; 2 dosing periods each separated by 7 days washout | 24 hours |
| Stage 1: Urine polyphenols concentration | 24 hour dosing period; 2 dosing periods each separated by 7 days washout | 24 hours |
| Stage 1: Urine triterpenes concentration | 24 hour dosing period; 2 dosing periods each separated by 7 days washout | 24 hours |
| Stage 2: Plasma polyphenols concentration | 30 days | 30 days dosing period or 30 days as control group separated by 15 days washout |
| Stage 2: Plasma triterpenes concentration | 30 days | 30 days dosing period or 30 days as control group separated by 15 days washout |
| Stage 2: Urine polyphenols concentration | 30 days | 30 days dosing period or 30 days as control group separated by 15 days washout |
| Stage 2: Urine triterpenes concentration | 30 days | 30 days dosing period or 30 days as control group separated by 15 days washout |
| Stage 2: Malondialdehyde concentration | 30 days | 30 days dosing period or 30 days as control group separated by 15 days washout |
| Stage 2: Catalase concentration | 30 days | 30 days dosing period or 30 days as control group separated by 15 days washout |
| Stage 2: Glutathione peroxidase concentration | 30 days | 30 days dosing period or 30 days as control group separated by 15 days washout |
| Stage 2: Superoxide dismutase concentration | 30 days | 30 days dosing period or 30 days as control group separated by 15 days washout |
| Stage 2: F2A isoprostane concentration | 30 days | 30 days dosing period or 30 days as control group separated by 15 days washout |
| Stage 2: 8 isoprostane concentration | 30 days | 30 days dosing period or 30 days as control group separated by 15 days washout |
| Stage 2: Oxidized low-density lipoprotein concentration | 30 days | 30 days dosing period or 30 days as control group separated by 15 days washout |
| Stage 2: C-Reactive Protein concentration | 30 days | 30 days dosing period or 30 days as control group separated by 15 days washout |
| Stage 2: Lipoprotein-associated phospholipase A2 concentration | 30 days | 30 days dosing period or 30 days as control group separated by 15 days washout |
| Stage 2: Apolipoprotein A1 concentration | 30 days | 30 days dosing period or 30 days as control group separated by 15 days washout |
| Stage 2: Apolipoprotein B100 concentration | 30 days | 30 days dosing period or 30 days as control group separated by 15 days washout |
| Stage 2: Tumor necrosis factor alpha concentration | 30 days | 30 days dosing period or 30 days as control group separated by 15 days washout |
| Stage 2: Interleukin 6 concentration | 30 days | 30 days dosing period or 30 days as control group separated by 15 days washout |
| Stage 2: Interleukin 1 concentration | 30 days | 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 | 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 | 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 | 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) | 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) | 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) | 30 days | 30 days dosing period or 30 days as control group separated by 15 days washout |
| Stage 2: Triglyceride concentration | 30 days | 30 days dosing period or 30 days as control group separated by 15 days washout |
| Stage 2: Total cholesterol concentration | 30 days | 30 days dosing period or 30 days as control group separated by 15 days washout |
| Stage 2: Sodium concentration | 30 days | 30 days dosing period or 30 days as control group separated by 15 days washout |
| Stage 2: Glucose concentration | 30 days | 30 days dosing period or 30 days as control group separated by 15 days washout |
| Stage 2: Urea concentration | 30 days | 30 days dosing period or 30 days as control group separated by 15 days washout |
| Stage 2: Creatinine concentration | 30 days | 30 days dosing period or 30 days as control group separated by 15 days washout |
| Stage 2: Aspartate aminotransferase concentration | 30 days | 30 days dosing period or 30 days as control group separated by 15 days washout |
| Stage 2: Alanine aminotransferase concentration | 30 days | 30 days dosing period or 30 days as control group separated by 15 days washout |
| Stage 2: Alkaline phosphatase concentration | 30 days | 30 days dosing period or 30 days as control group separated by 15 days washout |
| Stage 2: Total proteins concentration | 30 days | 30 days dosing period or 30 days as control group separated by 15 days washout |
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