Effects of Enzymatic Digestion and Probiotic on Oleuropein Bioavailability

Healthy Subjects Clinical Trial

Official title:

Effects of Enzymatic Digestion and Probiotic on Oleuropein Bioavailability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04328571
• Other study ID #: 1907NRC
• Status: Completed
• Phase: N/A
• Start date: February 10, 2020
• Est. completion date: September 15, 2021

Study information

• Verified date: September 2021
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: September 15, 2021
• Est. primary completion date: May 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Dietary Supplement:
• OLE enzymatically treated
OLE (Olive leaf extract ) enzymatically treated + maltodextrin
• OLE + probiotic
OLE (Olive leaf extract) co-administered with probiotic
• OLE
OLE (Olive leaf extract) + maltodextrin

Locations

Country	Name	City	State
Spain	Universidad Católica San Antonio	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Change of gut microbiota faecal branched chain fatty acids	Change from baseline to end of the 3-week intervention period of gut microbiota faecal branched chain fatty acids (isobutyrate, isovalerate & isocaproate)	3 weeks
Other	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
Other	Blood levels of total cholesterol	Change from baseline to the end of the 3-week intervention period of total cholesterol levels	3 weeks
Other	Blood levels of LDL	Change from baseline to the end of the 3-week intervention period of LDL levels	3 weeks
Other	Blood levels of HDL	Change from baseline to the end of the 3-week intervention period of HDL levels	3 weeks
Other	Blood levels of ALAT	Change from baseline to the end of the 3-week intervention period of ALAT levels	3 weeks
Other	Blood levels of ASAT	Change from baseline to the end of the 3-week intervention period of ASAT levels	3 weeks
Other	Blood levels of creatinine	Change from baseline to the end of the 3-week intervention period of creatinine levels	3 weeks
Other	Blood levels of glucose	Change from baseline to the end of the 3-week intervention period of glucose levels	3 weeks
Other	Blood levels of triglycerides	Change from baseline to the end of the 3-week intervention period of triglycerides levels	3 weeks
Other	Blood levels of bone biomarkers	Change from baseline to the end of the 3-week intervention period of bone biomarkers (P1NP, CTX)	3 weeks
Other	Blood levels of Oxidized LDL	Change from baseline to the end of the 3-week intervention period of Oxidized LDL	3 weeks
Other	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
Primary	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
Secondary	Cmax during PK2 period	Cmax of total and individual oleuropein metabolites during PK2 period	24 hours
Secondary	Tmax during PK2 period	Tmax of total and individual oleuropein metabolites during PK2 period	24 hours
Secondary	T1/2 during PK2 period	T1/2 of total and individual oleuropein metabolites during PK2 period	24 hours
Secondary	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
Secondary	AUC0-24h during PK1	AUC0-24h (concentration/time curve) of individual blood oleuropein metabolites during PK1 period	24 hours
Secondary	Cmax during PK1	Cmax of total and individual blood oleuropein metabolites during PK1 period	24 hours
Secondary	Tmax during PK1	Tmax of total and individual blood oleuropein metabolites during PK1 period	24 hours
Secondary	T1/2 during PK1	T1/2 of total and individual blood oleuropein metabolites during PK1 period	24 hours
Secondary	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
Secondary	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
Secondary	Change in levels of faecal oleuropein metabolites	Change from baseline to end of the 3-week intervention period of faecal oleuropein metabolites	3 weeks