Healthy Subjects
Conditions
Brief 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
Interventions
DIETARY_SUPPLEMENTOLE enzymatically treated
OLE (Olive leaf extract ) enzymatically treated + maltodextrin
DIETARY_SUPPLEMENTOLE + probiotic
OLE (Olive leaf extract) co-administered with probiotic
DIETARY_SUPPLEMENTOLE
OLE (Olive leaf extract) + maltodextrin
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Single coding
Intervention model description
3-arms randomized-controlled, parallel group, single center, double-blinded study investigating 3 different formulations of the investigational product
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Willing and able to sign written informed consent prior to trial entry 2. Male or female healthy adults between 25 and 65 years of age 3. Body Mass Index (BMI) within the range 18.5 - 29.9 (both inclusive) 4. In good health as determined by medical judgment and medical history
Exclusion criteria
1. Any food allergy/intolerance 2. Subjects not willing and/or not able to comply with scheduled visits and the requirements of the study protocol 3. Taking or anticipated initiation of any lipid-modifying or blood-clotting medication e.g. statins, cholesterol lowering 4. Smokers 5. Alcohol intake higher than 2 servings per day (one serving is 0.4 dL of strong alcohol, 1 dL of wine, or 3 dL of beer) or drug abuse 6. Receiving or having received antibiotics in the past 4 weeks prior to the day of inclusion 7. Overly imbalanced or restrictive diet (e.g. hyperproteic, vegan, ketogenic, etc.) 8. Hormonal treatment for women linked to menopause (contraceptive treatment accepted) 9. Pregnancy or breastfeeding 10. Supplements or foods containing probiotics (yogurts allowed) 11. Currently participating or having participated in another clinical trial within 4 weeks prior to trial start
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-24h of individual blood oleuropein metabolites during PK2 period | 24 hours | AUC0-24h (concentration/time curve) of individual blood oleuropein metabolites during PK2 period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tmax during PK2 period | 24 hours | Tmax of total and individual oleuropein metabolites during PK2 period |
| T1/2 during PK2 period | 24 hours | T1/2 of total and individual oleuropein metabolites during PK2 period |
| Levels of total and individual oleuropein metabolites in urine at PK2 | 24 hours | Levels of total and individual oleuropein metabolites excreted in the urine collected over 24 hours during PK2 |
| AUC0-24h during PK1 | 24 hours | AUC0-24h (concentration/time curve) of individual blood oleuropein metabolites during PK1 period |
| Cmax during PK1 | 24 hours | Cmax of total and individual blood oleuropein metabolites during PK1 period |
| Cmax during PK2 period | 24 hours | Cmax of total and individual oleuropein metabolites during PK2 period |
| T1/2 during PK1 | 24 hours | T1/2 of total and individual blood oleuropein metabolites during PK1 period |
| Levels of total and individual oleuropein metabolites in urine at PK1 | 24 hours | Levels of total and individual oleuropein metabolites excreted in the urine collected over 24 hours during PK1 |
| Change in gut microbiota bacterial population diversity | 3 weeks | Change from baseline to end of the 3-week intervention period of gut microbiota bacterial population diversity (16SrDNA sequencing) |
| Change in levels of faecal oleuropein metabolites | 3 weeks | Change from baseline to end of the 3-week intervention period of faecal oleuropein metabolites |
| Tmax during PK1 | 24 hours | Tmax of total and individual blood oleuropein metabolites during PK1 period |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blood levels of bone biomarkers | 3 weeks | Change from baseline to the end of the 3-week intervention period of bone biomarkers (P1NP, CTX) |
| Levels of biomarkers of oxidative stress | 3 weeks | 8-NO2GU, 8-OH-GU, 8-OH GUO, 8-OH-DGUO, 8 NO2 GUO, cGMP, 8-NO2-cGMP, Prostanoids, Oxylipins, Isoprostanes, Phytoprostanes and Phytofuranes |
| Blood levels of Oxidized LDL | 3 weeks | Change from baseline to the end of the 3-week intervention period of Oxidized LDL |
| Change of gut microbiota faecal short chain fatty acids | 3 weeks | Change from baseline to end of the 3-week intervention period of gut microbiota faecal short chain fatty acids (acetate, propionate, butyrate) & lactate |
| Change of gut microbiota faecal branched chain fatty acids | 3 weeks | Change from baseline to end of the 3-week intervention period of gut microbiota faecal branched chain fatty acids (isobutyrate, isovalerate & isocaproate) |
| Change of gut microbiota faecal ammonium production | 3 weeks | Change from baseline to end of the 3-week intervention period of gut microbiota faecal ammonium production |
| Blood levels of total cholesterol | 3 weeks | Change from baseline to the end of the 3-week intervention period of total cholesterol levels |
| Blood levels of LDL | 3 weeks | Change from baseline to the end of the 3-week intervention period of LDL levels |
| Blood levels of HDL | 3 weeks | Change from baseline to the end of the 3-week intervention period of HDL levels |
| Blood levels of ALAT | 3 weeks | Change from baseline to the end of the 3-week intervention period of ALAT levels |
| Blood levels of ASAT | 3 weeks | Change from baseline to the end of the 3-week intervention period of ASAT levels |
| Blood levels of creatinine | 3 weeks | Change from baseline to the end of the 3-week intervention period of creatinine levels |
| Blood levels of glucose | 3 weeks | Change from baseline to the end of the 3-week intervention period of glucose levels |
| Blood levels of triglycerides | 3 weeks | Change from baseline to the end of the 3-week intervention period of triglycerides levels |
Countries
Spain
Outcome results
None listed