Effects of Enzymatic Digestion and Probiotic on Oleuropein Bioavailability

Not Applicable

Completed

• Conditions: Healthy Subjects

• Registration Number: NCT04328571
• Lead Sponsor: Société des Produits Nestlé (SPN)

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

Study Timeline

• Study Start: 2020-02-10
• Study First Submitted: 2020-03-05
• Study First Submitted QC: 2020-03-30
• Study First Posted: 2020-03-31
• Primary Completion: 2021-05-15
• Status Verified: 2021-09
• Study Completion: 2021-09-15
• Last Update Submitted: 2021-09-30
• Last Update Posted: 2021-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Cmax during PK2 period	24 hours	Cmax of total and individual oleuropein metabolites during PK2 period
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
Tmax during PK1	24 hours	Tmax of total and individual blood oleuropein metabolites during PK1 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

Trial Locations

Locations (1)

Universidad Católica San Antonio; 🇪🇸 Murcia, Spain