Clinical trial NCT04328571: Effects of Enzymatic Digestion and Probiotic on Oleuropein Bioavailability
Official title: Effects of Enzymatic Digestion and Probiotic on Oleuropein Bioavailability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2020-03-31
Enrollment: 104
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3-arms randomized-controlled, parallel group, single center, double-blinded study investigating 3 different formulations of the investigational product
Primary purpose: BASIC_SCIENCE

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

Eligibility criteria: 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

Primary outcomes:
measure: AUC0-24h of individual blood oleuropein metabolites during PK2 period
timeFrame: 24 hours
Secondary outcomes:
measure: Cmax during PK2 period
timeFrame: 24 hours
measure: Tmax during PK2 period
timeFrame: 24 hours
measure: T1/2 during PK2 period
timeFrame: 24 hours
measure: Levels of total and individual oleuropein metabolites in urine at PK2
timeFrame: 24 hours
measure: AUC0-24h during PK1
timeFrame: 24 hours
measure: Cmax during PK1
timeFrame: 24 hours
measure: Tmax during PK1
timeFrame: 24 hours
measure: T1/2 during PK1
timeFrame: 24 hours
measure: Levels of total and individual oleuropein metabolites in urine at PK1
timeFrame: 24 hours
measure: Change in gut microbiota bacterial population diversity
timeFrame: 3 weeks
measure: Change in levels of faecal oleuropein metabolites
timeFrame: 3 weeks
Other outcomes:
measure: Change of gut microbiota faecal short chain fatty acids
timeFrame: 3 weeks
measure: Change of gut microbiota faecal branched chain fatty acids
timeFrame: 3 weeks
measure: Change of gut microbiota faecal ammonium production
timeFrame: 3 weeks
measure: Blood levels of total cholesterol
timeFrame: 3 weeks
measure: Blood levels of LDL
timeFrame: 3 weeks
measure: Blood levels of HDL
timeFrame: 3 weeks
measure: Blood levels of ALAT
timeFrame: 3 weeks
measure: Blood levels of ASAT
timeFrame: 3 weeks
measure: Blood levels of creatinine
timeFrame: 3 weeks
measure: Blood levels of glucose
timeFrame: 3 weeks
measure: Blood levels of triglycerides
timeFrame: 3 weeks
measure: Blood levels of bone biomarkers
timeFrame: 3 weeks
measure: Blood levels of Oxidized LDL
timeFrame: 3 weeks
measure: Levels of biomarkers of oxidative stress
timeFrame: 3 weeks
Locations:
city: Murcia
country: Spain
facility: Universidad Católica San Antonio
Study officials:
affiliation: CEBAS-CSIC, Murcia, Spain
name: Francisco A. Tomás-Barberán, Prof.
role: PRINCIPAL_INVESTIGATOR
References: