Biological Availability, Functional Food, Healthy, Nutritional Intervention, Nutrition Physiology
Conditions
Keywords
Polyphenols, Triterpenes, Olea europaea, Table Olives, Pharmacokinetics, Functional Food, Antioxidant, Cardiovascular Disease, Anti-inflammatory
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.
Interventions
OTHERTable Olives
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.
Sponsors
Ministerio de Economía y Competitividad (Spain) AGL 2013-41188R
University of Barcelona
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stage 2: Interleukin 1 concentration | 30 days dosing period or 30 days as control group separated by 15 days washout | 30 days |
| Stage 1: Urine triterpenes concentration | 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: Plasma triterpenes concentration | 30 days dosing period or 30 days as control group separated by 15 days washout | 30 days |
| Stage 2: Urine polyphenols concentration | 30 days dosing period or 30 days as control group separated by 15 days washout | 30 days |
| Stage 2: Urine 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: Catalase 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: Superoxide dismutase 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: 8 isoprostane 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 2: C-Reactive Protein 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: Apolipoprotein A1 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: Tumor necrosis factor alpha 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 |
| Stage 1: Terminal elimination rate constant (Kel) | 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 1: Volume of distribution (Vd/ F) | 24 hours | 24 hour dosing period; 2 dosing periods each separated by 7 days washout |
| Stage 1: Clearance (Cl/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: 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 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: Percentage of AUC extrapolated (AUC%) | 24 hours | 24 hour dosing period; 2 dosing periods each separated by 7 days washout |
| 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: 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: 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 1: Urine polyphenols concentration | 24 hours | 24 hour dosing period; 2 dosing periods each separated by 7 days washout |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stage 2: Aspartate aminotransferase 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: Alkaline phosphatase 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 |
| 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: 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: 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 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: Body weight | 30 days dosing period or 30 days as control group separated by 15 days washout | 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: 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: 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: Triglyceride concentration | 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: Sodium 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: Urea 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 |
Countries
Spain
Outcome results
None listed