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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
104
OLE (Olive leaf extract ) enzymatically treated + maltodextrin
OLE (Olive leaf extract) co-administered with probiotic
OLE (Olive leaf extract) + maltodextrin
Universidad Católica San Antonio
Murcia, Spain
AUC0-24h of individual blood oleuropein metabolites during PK2 period
AUC0-24h (concentration/time curve) of individual blood oleuropein metabolites during PK2 period
Time frame: 24 hours
Cmax during PK2 period
Cmax of total and individual oleuropein metabolites during PK2 period
Time frame: 24 hours
Tmax during PK2 period
Tmax of total and individual oleuropein metabolites during PK2 period
Time frame: 24 hours
T1/2 during PK2 period
T1/2 of total and individual oleuropein metabolites during PK2 period
Time frame: 24 hours
Levels of total and individual oleuropein metabolites in urine at PK2
Levels of total and individual oleuropein metabolites excreted in the urine collected over 24 hours during PK2
Time frame: 24 hours
AUC0-24h during PK1
AUC0-24h (concentration/time curve) of individual blood oleuropein metabolites during PK1 period
Time frame: 24 hours
Cmax during PK1
Cmax of total and individual blood oleuropein metabolites during PK1 period
Time frame: 24 hours
Tmax during PK1
Tmax of total and individual blood oleuropein metabolites during PK1 period
Time frame: 24 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
T1/2 during PK1
T1/2 of total and individual blood oleuropein metabolites during PK1 period
Time frame: 24 hours
Levels of total and individual oleuropein metabolites in urine at PK1
Levels of total and individual oleuropein metabolites excreted in the urine collected over 24 hours during PK1
Time frame: 24 hours
Change in gut microbiota bacterial population diversity
Change from baseline to end of the 3-week intervention period of gut microbiota bacterial population diversity (16SrDNA sequencing)
Time frame: 3 weeks
Change in levels of faecal oleuropein metabolites
Change from baseline to end of the 3-week intervention period of faecal oleuropein metabolites
Time frame: 3 weeks