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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:
52 subjects will be randomized to achieve 15 subjects per group to complete the trial.
The study will involve 3 phases:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OLE enzymatically treated | Experimental | Participants will receive 1 capsule of OLE enzymatically treated + 1 stick of maltodextrin each day in the morning for 21 days |
|
| OLE + probiotic | Experimental | Participants will receive 1 capsule of OLE + 1 stick of probiotic each day in the morning for 21 days |
|
| OLE | Active Comparator | Participants will receive 1 capsule of OLE + 1 stick of maltodextrin each day in the morning for 21 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OLE enzymatically treated | Dietary Supplement | OLE (Olive leaf extract ) enzymatically treated + maltodextrin |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-24h of individual blood oleuropein metabolites during PK2 period | AUC0-24h (concentration/time curve) of individual blood oleuropein metabolites during PK2 period | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax during PK2 period | Cmax of total and individual oleuropein metabolites during PK2 period | 24 hours |
| Tmax during PK2 period | Tmax of total and individual oleuropein metabolites during PK2 period |
| Measure | Description | Time Frame |
|---|---|---|
| Change of gut microbiota faecal short chain fatty acids | Change from baseline to end of the 3-week intervention period of gut microbiota faecal short chain fatty acids (acetate, propionate, butyrate) & lactate | 3 weeks |
| Change of gut microbiota faecal branched chain fatty acids |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francisco A. Tomás-Barberán, Prof. | CEBAS-CSIC, Murcia, Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Católica San Antonio | Murcia | 30107 | Spain |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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3-arms randomized-controlled, parallel group, single center, double-blinded study investigating 3 different formulations of the investigational product
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Single coding
| OLE + probiotic | Dietary Supplement | OLE (Olive leaf extract) co-administered with probiotic |
|
| OLE | Dietary Supplement | OLE (Olive leaf extract) + maltodextrin |
|
| 24 hours |
| T1/2 during PK2 period | T1/2 of total and individual oleuropein metabolites during PK2 period | 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 | 24 hours |
| AUC0-24h during PK1 | AUC0-24h (concentration/time curve) of individual blood oleuropein metabolites during PK1 period | 24 hours |
| Cmax during PK1 | Cmax of total and individual blood oleuropein metabolites during PK1 period | 24 hours |
| Tmax during PK1 | Tmax of total and individual blood oleuropein metabolites during PK1 period | 24 hours |
| T1/2 during PK1 | T1/2 of total and individual blood oleuropein metabolites during PK1 period | 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 | 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) | 3 weeks |
| Change in levels of faecal oleuropein metabolites | Change from baseline to end of the 3-week intervention period of faecal oleuropein metabolites | 3 weeks |
Change from baseline to end of the 3-week intervention period of gut microbiota faecal branched chain fatty acids (isobutyrate, isovalerate & isocaproate) |
| 3 weeks |
| Change of gut microbiota faecal ammonium production | Change from baseline to end of the 3-week intervention period of gut microbiota faecal ammonium production | 3 weeks |
| Blood levels of total cholesterol | Change from baseline to the end of the 3-week intervention period of total cholesterol levels | 3 weeks |
| Blood levels of LDL | Change from baseline to the end of the 3-week intervention period of LDL levels | 3 weeks |
| Blood levels of HDL | Change from baseline to the end of the 3-week intervention period of HDL levels | 3 weeks |
| Blood levels of ALAT | Change from baseline to the end of the 3-week intervention period of ALAT levels | 3 weeks |
| Blood levels of ASAT | Change from baseline to the end of the 3-week intervention period of ASAT levels | 3 weeks |
| Blood levels of creatinine | Change from baseline to the end of the 3-week intervention period of creatinine levels | 3 weeks |
| Blood levels of glucose | Change from baseline to the end of the 3-week intervention period of glucose levels | 3 weeks |
| Blood levels of triglycerides | Change from baseline to the end of the 3-week intervention period of triglycerides levels | 3 weeks |
| Blood levels of bone biomarkers | Change from baseline to the end of the 3-week intervention period of bone biomarkers (P1NP, CTX) | 3 weeks |
| Blood levels of Oxidized LDL | Change from baseline to the end of the 3-week intervention period of Oxidized LDL | 3 weeks |
| Levels of biomarkers of oxidative stress | 8-NO2GU, 8-OH-GU, 8-OH GUO, 8-OH-DGUO, 8 NO2 GUO, cGMP, 8-NO2-cGMP, Prostanoids, Oxylipins, Isoprostanes, Phytoprostanes and Phytofuranes | 3 weeks |
| D019602 |
| Food and Beverages |