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Clinical Trial Summary

This is a 3-arms randomized-controlled, parallel group, single center, double-blind study investigating the bioavailability of olive oil extract (OLE) in two different OLE formulations (enzymatically treated and co-administered with a probiotic) compared to original OLE formulation in healthy adult subjects.


Clinical Trial Description

Male or female healthy adults between 25 and 65 years of age will be randomized into one of the 3 following groups to receive: 1. Capsule of OLE + 1 stick of maltodextrin 2. Capsule of OLE enzymatically treated + 1 stick of maltodextrin 3. Capsule OLE + 1 stick of probiotic 52 subjects will be randomized to achieve 15 subjects per group to complete the trial. The study will involve 3 phases: 1. PK1 (all subjects will receive one capsule of OLE in the morning and blood samples will be collected at different timepoints for 24h) followed by a washout period of 1 day 2. 3 weeks intervention (subjects will receive the product thy have benn assigned to) followed by a wash-out period of 3 days 3. PK2 period (subjects will receive one capsule the product thy have benn assigned to ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04328571
Study type Interventional
Source Nestlé
Contact
Status Completed
Phase N/A
Start date February 10, 2020
Completion date September 15, 2021

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