NCT04328571

Effects of Enzymatic Digestion and Probiotic on Oleuropein Bioavailability

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	OLE enzymatically treated	OLE (Olive leaf extract ) enzymatically treated + maltodextrin
DIETARY_SUPPLEMENT	OLE + probiotic	OLE (Olive leaf extract) co-administered with probiotic
DIETARY_SUPPLEMENT	OLE	OLE (Olive leaf extract) + maltodextrin

Timeline

• Start date: 2020-02-10
• Primary completion: 2021-05-15
• Completion: 2021-09-15
• First posted: 2020-03-31
• Last updated: 2021-10-01

Locations

1 site across 1 country: Spain