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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
58
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.
Institut de Recerca Hospital de la Santa Creu i Sant Pau - CIM Sant Pau
Barcelona, Spain
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
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
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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