Effects of Enzymatic Digestion and Probiotic on Oleuropein Bioavailability
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Healthy Subjects
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: 3-arms randomized-controlled, parallel group, single center, double-blinded study investigating 3 different formulations of the investigational productMasking: Triple (Participant, Investigator, Outcomes Assessor)Masking Description: Single codingPrimary Purpose: Basic Science
Participation Requirements
- Age
- Between 25 years and 65 years
- Gender
- Both males and females
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: Capsule of OLE + 1 stick of maltodextrin Capsule of OLE enzymatically treated + 1 stick of maltodextrin Capsule OLE + 1 stick of probiotic 52 subjects will be randomized to ...
Male or female healthy adults between 25 and 65 years of age will be randomized into one of the 3 following groups to receive: Capsule of OLE + 1 stick of maltodextrin Capsule of OLE enzymatically treated + 1 stick of maltodextrin 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: 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 3 weeks intervention (subjects will receive the product thy have benn assigned to) followed by a wash-out period of 3 days PK2 period (subjects will receive one capsule the product thy have benn assigned to
Tracking Information
- NCT #
- NCT04328571
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Francisco A. Tomás-Barberán, Prof. CEBAS-CSIC, Murcia, Spain
Get Well Soon