Clinical trial NCT03886597: Nutritional Intervention With Table Olives in Healthy Volunteers
Official title: Table Olives Nutritional Intervention: Pharmacokinetics of Polyphenols and Pentacyclic Triterpenes and Assessment of Antioxidant, Cardiovascular and Anti-inflammatory Biomarkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy
Biological Availability
Nutritional Intervention
Functional Food
Nutrition Physiology
Keywords: Polyphenols
Triterpenes
Olea europaea
Table Olives
Pharmacokinetics
Functional Food
Antioxidant
Cardiovascular Disease
Anti-inflammatory
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Ministerio de Economía y Competitividad (Spain) AGL 2013-41188R
name: University of Barcelona
First posted: 2019-03-22
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Stage 1: Maximum plasma concentration (Cmax)
timeFrame: 24 hours
measure: Stage 1: Concentration at the end of the dosing interval (Ct)
timeFrame: 24 hours
measure: Stage 1: Time until Cmax is reached (Tmax)
timeFrame: 24 hours
measure: Stage 1: Area under the curve from administration to last observed concentration at time (AUC (0-t)
timeFrame: 24 hours
measure: Stage 1: AUC extrapolated to infinite time (AUC (0-∞)
timeFrame: 24 hours
measure: Stage 1: Percentage of AUC extrapolated (AUC%)
timeFrame: 24 hours
measure: Stage 1: Terminal elimination rate constant (Kel)
timeFrame: 24 hours
measure: Stage 1: Plasma concentration half-life (t ½)
timeFrame: 24 hours
measure: Stage 1: Volume of distribution (Vd/ F)
timeFrame: 24 hours
measure: Stage 1: Clearance (Cl/F)
timeFrame: 24 hours
measure: Stage 1: Peak trough fluctuation over one dosing interval at steady state (PTF)
timeFrame: 24 hours
measure: Stage 1: Cmax dose normalized (Cmax/Dose)
timeFrame: 24 hours
measure: Stage 1: AUC (0-t) dose normalized (AUC (0-t)/Dose)
timeFrame: 24 hours
measure: Stage 1: Urine polyphenols concentration
timeFrame: 24 hours
measure: Stage 1: Urine triterpenes concentration
timeFrame: 24 hours
measure: Stage 2: Plasma polyphenols concentration
timeFrame: 30 days dosing period or 30 days as control group separated by 15 days washout
measure: Stage 2: Plasma triterpenes concentration
timeFrame: 30 days dosing period or 30 days as control group separated by 15 days washout
measure: Stage 2: Urine polyphenols concentration
timeFrame: 30 days dosing period or 30 days as control group separated by 15 days washout
measure: Stage 2: Urine triterpenes concentration
timeFrame: 30 days dosing period or 30 days as control group separated by 15 days washout
measure: Stage 2: Malondialdehyde concentration
timeFrame: 30 days dosing period or 30 days as control group separated by 15 days washout
measure: Stage 2: Catalase concentration
timeFrame: 30 days dosing period or 30 days as control group separated by 15 days washout
measure: Stage 2: Glutathione peroxidase concentration
timeFrame: 30 days dosing period or 30 days as control group separated by 15 days washout
measure: Stage 2: Superoxide dismutase concentration
timeFrame: 30 days dosing period or 30 days as control group separated by 15 days washout
measure: Stage 2: F2A isoprostane concentration
timeFrame: 30 days dosing period or 30 days as control group separated by 15 days washout
measure: Stage 2: 8 isoprostane concentration
timeFrame: 30 days dosing period or 30 days as control group separated by 15 days washout
measure: Stage 2: Oxidized low-density lipoprotein concentration
timeFrame: 30 days dosing period or 30 days as control group separated by 15 days washout
measure: Stage 2: C-Reactive Protein concentration
timeFrame: 30 days dosing period or 30 days as control group separated by 15 days washout
measure: Stage 2: Lipoprotein-associated phospholipase A2 concentration
timeFrame: 30 days dosing period or 30 days as control group separated by 15 days washout
measure: Stage 2: Apolipoprotein A1 concentration
timeFrame: 30 days dosing period or 30 days as control group separated by 15 days washout
measure: Stage 2: Apolipoprotein B100 concentration
timeFrame: 30 days dosing period or 30 days as control group separated by 15 days washout
measure: Stage 2: Tumor necrosis factor alpha concentration
timeFrame: 30 days dosing period or 30 days as control group separated by 15 days washout
measure: Stage 2: Interleukin 6 concentration
timeFrame: 30 days dosing period or 30 days as control group separated by 15 days washout
measure: Stage 2: Interleukin 1 concentration
timeFrame: 30 days dosing period or 30 days as control group separated by 15 days washout
Secondary outcomes:
measure: Stage 1 and 2: Number of participants with treatment-related adverse events
timeFrame: 30 days dosing period or 30 days as control group separated by 15 days washout
measure: Stage 1 and 2: Systolic and diastolic blood pressure
timeFrame: 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
measure: Stage 1 and 2: Heart rate
timeFrame: 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
measure: Stage 1 and 2: Respiratory rate
timeFrame: 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
measure: Stage 2: Body weight
timeFrame: 30 days dosing period or 30 days as control group separated by 15 days washout
measure: Stage 2: High-density lipoprotein cholesterol concentration (HDL-C)
timeFrame: 30 days dosing period or 30 days as control group separated by 15 days washout
measure: Stage 2: Low-density lipoprotein cholesterol concentration (LDL-C)
timeFrame: 30 days dosing period or 30 days as control group separated by 15 days washout
measure: Stage 2: Very low-density lipoprotein cholesterol concentration (VLDL-C)
timeFrame: 30 days dosing period or 30 days as control group separated by 15 days washout
measure: Stage 2: Triglyceride concentration
timeFrame: 30 days dosing period or 30 days as control group separated by 15 days washout
measure: Stage 2: Total cholesterol concentration
timeFrame: 30 days dosing period or 30 days as control group separated by 15 days washout
measure: Stage 2: Sodium concentration
timeFrame: 30 days dosing period or 30 days as control group separated by 15 days washout
measure: Stage 2: Glucose concentration
timeFrame: 30 days dosing period or 30 days as control group separated by 15 days washout
measure: Stage 2: Urea concentration
timeFrame: 30 days dosing period or 30 days as control group separated by 15 days washout
measure: Stage 2: Creatinine concentration
timeFrame: 30 days dosing period or 30 days as control group separated by 15 days washout
measure: Stage 2: Aspartate aminotransferase concentration
timeFrame: 30 days dosing period or 30 days as control group separated by 15 days washout
measure: Stage 2: Alanine aminotransferase concentration
timeFrame: 30 days dosing period or 30 days as control group separated by 15 days washout
measure: Stage 2: Alkaline phosphatase concentration
timeFrame: 30 days dosing period or 30 days as control group separated by 15 days washout
measure: Stage 2: Total proteins concentration
timeFrame: 30 days dosing period or 30 days as control group separated by 15 days washout
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Institut de Recerca Hospital de la Santa Creu i Sant Pau - CIM Sant Pau
Study officials:
affiliation: Departament de Bioquímica i Fisiologia. Facultat de Farmàcia i Ciències de l´Alimentació. Universitat de Barcelona
name: Joana M Planas, PhD Prof.
role: STUDY_DIRECTOR
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