Healthy Subjects Clinical Trial
Official title:
Effects of Enzymatic Digestion and Probiotic on Oleuropein Bioavailability
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.
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 ;
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