Nutritional Intervention With Table Olives in Healthy Volunteers
Condition: Healthy; Biological Availability; Nutritional Intervention; Functional Food; Nutrition Physiology
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    


Intervention name(s): Table Olives; Table Olives; Table Olives
Intervention type(s): Other; Other; Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Crossover Assignment
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.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Polyphenols; Triterpenes; Olea europaea; Table Olives; Pharmacokinetics; Functional Food; Antioxidant; Cardiovascular Disease; Anti-inflammatory