Nutritional Intervention With Table Olives in Healthy Volunteers
- Conditions
- Biological AvailabilityHealthyNutritional InterventionFunctional FoodNutrition Physiology
- Interventions
- Other: Table Olives
- Registration Number
- NCT03886597
- Lead Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Brief Summary
Olives and olive oil are typical components of the Mediterranean diet being part of its cultural and gastronomic heritage. Since ancient times, olives have been used either for both, oil extraction or whole fruit consumption as table olives. Olive oil stands out from both the nutritional and the health point of view. However, the effect of table olives consumption remains almost unknown. The beneficial properties of olive oil have been initially ascribed to the high concentration of oleic acid. Nowadays, these positive effects have been attributed also to minor compounds such as polyphenols or pentacyclic triterpenes. Table olives contain a higher amount of both polyphenols and pentacyclic triterpenes than their oil, with the same healthy fatty acid profile. Therefore, the present intervention aims at investigating the pharmacokinetic of polyphenols and pentacyclic triterpenes after a single olive intake as well as the assessment of the effect of the consumption of olives during 30 days on the overall health status playing particular attention to the anti-inflammatory, antioxidant and cardiovascular biomarkers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
- 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.
- Smoking.
- Alcohol or drug abuse.
- Heavy consumer of stimulating beverages (>5 coffees, teas, chocolate or cola drinks per day) and grapefruit juice.
- Background of allergy, idiosyncrasy or hypersensitivity to drugs.
- Intake of any medication within 2 weeks prior taking the study intervention (except for use of paracetamol in short-term symptomatic treatments), including over-the-counter products (including natural food supplements, vitamins and medicinal plants products), or any enzymatic inductor or inhibitor within 3 months before the drug administration.
- Positive serology for hepatitis B, C or HIV.
- Background or clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, hematological or neurological disease or other chronic diseases.
- Having undergone major surgery during the previous 6 months.
- Pregnancy or lactation status (if applied).
- Participation in another clinical trial during the 3 months preceding the drug administration.
- Donation of blood during the 4 weeks preceding the drug administration.
- Acute illness four weeks before drug administration.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 120 Arbequina Table Olives Table Olives Pharmacokinetics Study 60 Arbequina Table Olives Table Olives Pharmacokinetics Study 60 Table Olives Table Olives Table Olives Nutritional Intervention
- Primary Outcome Measures
Name Time Method Stage 1: Peak trough fluctuation over one dosing interval at steady state (PTF) 24 hours 24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 2: Plasma polyphenols concentration 30 days dosing period or 30 days as control group separated by 15 days washout 30 days
Stage 2: Catalase concentration 30 days dosing period or 30 days as control group separated by 15 days washout 30 days
Stage 2: Oxidized low-density lipoprotein concentration 30 days dosing period or 30 days as control group separated by 15 days washout 30 days
Stage 1: Clearance (Cl/F) 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) 24 hours 24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 2: 8 isoprostane concentration 30 days dosing period or 30 days as control group separated by 15 days washout 30 days
Stage 1: AUC extrapolated to infinite time (AUC (0-∞) 24 hours 24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 1: Volume of distribution (Vd/ F) 24 hours 24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 1: Cmax dose normalized (Cmax/Dose) 24 hours 24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 1: Urine polyphenols concentration 24 hours 24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 2: Plasma triterpenes concentration 30 days dosing period or 30 days as control group separated by 15 days washout 30 days
Stage 2: Malondialdehyde concentration 30 days dosing period or 30 days as control group separated by 15 days washout 30 days
Stage 2: Superoxide dismutase concentration 30 days dosing period or 30 days as control group separated by 15 days washout 30 days
Stage 2: Apolipoprotein A1 concentration 30 days dosing period or 30 days as control group separated by 15 days washout 30 days
Stage 1: Area under the curve from administration to last observed concentration at time (AUC (0-t) 24 hours 24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 1: Terminal elimination rate constant (Kel) 24 hours 24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 1: Urine triterpenes concentration 24 hours 24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 2: Urine polyphenols concentration 30 days dosing period or 30 days as control group separated by 15 days washout 30 days
Stage 1: Maximum plasma concentration (Cmax) 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) 24 hours 24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 1: Time until Cmax is reached (Tmax) 24 hours 24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 1: Percentage of AUC extrapolated (AUC%) 24 hours 24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 1: Plasma concentration half-life (t ½) 24 hours 24 hour dosing period; 2 dosing periods each separated by 7 days washout
Stage 2: Urine triterpenes concentration 30 days dosing period or 30 days as control group separated by 15 days washout 30 days
Stage 2: Glutathione peroxidase concentration 30 days dosing period or 30 days as control group separated by 15 days washout 30 days
Stage 2: F2A isoprostane concentration 30 days dosing period or 30 days as control group separated by 15 days washout 30 days
Stage 2: C-Reactive Protein concentration 30 days dosing period or 30 days as control group separated by 15 days washout 30 days
Stage 2: Tumor necrosis factor alpha concentration 30 days dosing period or 30 days as control group separated by 15 days washout 30 days
Stage 2: Lipoprotein-associated phospholipase A2 concentration 30 days dosing period or 30 days as control group separated by 15 days washout 30 days
Stage 2: Interleukin 1 concentration 30 days dosing period or 30 days as control group separated by 15 days washout 30 days
Stage 2: Apolipoprotein B100 concentration 30 days dosing period or 30 days as control group separated by 15 days washout 30 days
Stage 2: Interleukin 6 concentration 30 days dosing period or 30 days as control group separated by 15 days washout 30 days
- Secondary Outcome Measures
Name Time Method Stage 2: Body weight 30 days dosing period or 30 days as control group separated by 15 days washout 30 days
Stage 2: Very low-density lipoprotein cholesterol concentration (VLDL-C) 30 days dosing period or 30 days as control group separated by 15 days washout 30 days
Stage 2: Urea concentration 30 days dosing period or 30 days as control group separated by 15 days washout 30 days
Stage 2: Aspartate aminotransferase concentration 30 days dosing period or 30 days as control group separated by 15 days washout 30 days
Stage 1 and 2: Systolic and diastolic blood pressure 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 and 2: Respiratory rate 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 2: High-density lipoprotein cholesterol concentration (HDL-C) 30 days dosing period or 30 days as control group separated by 15 days washout 30 days
Stage 2: Total cholesterol concentration 30 days dosing period or 30 days as control group separated by 15 days washout 30 days
Stage 2: Glucose concentration 30 days dosing period or 30 days as control group separated by 15 days washout 30 days
Stage 2: Alkaline phosphatase concentration 30 days dosing period or 30 days as control group separated by 15 days washout 30 days
Stage 1 and 2: Number of participants with treatment-related adverse events 30 days dosing period or 30 days as control group separated by 15 days washout 30 days
Stage 1 and 2: Heart rate 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 2: Low-density lipoprotein cholesterol concentration (LDL-C) 30 days dosing period or 30 days as control group separated by 15 days washout 30 days
Stage 2: Triglyceride concentration 30 days dosing period or 30 days as control group separated by 15 days washout 30 days
Stage 2: Sodium concentration 30 days dosing period or 30 days as control group separated by 15 days washout 30 days
Stage 2: Alanine aminotransferase concentration 30 days dosing period or 30 days as control group separated by 15 days washout 30 days
Stage 2: Creatinine concentration 30 days dosing period or 30 days as control group separated by 15 days washout 30 days
Stage 2: Total proteins concentration 30 days dosing period or 30 days as control group separated by 15 days washout 30 days
Trial Locations
- Locations (1)
Institut de Recerca Hospital de la Santa Creu i Sant Pau - CIM Sant Pau
🇪🇸Barcelona, Spain