Status:
COMPLETED
Effects of Enzymatic Digestion and Probiotic on Oleuropein Bioavailability
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Healthy Subjects
Eligibility:
All Genders
25-65 years
Phase:
NA
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 ...
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 enzymatica...
Eligibility Criteria
Inclusion
- Willing and able to sign written informed consent prior to trial entry
- Male or female healthy adults between 25 and 65 years of age
- Body Mass Index (BMI) within the range 18.5 - 29.9 (both inclusive)
- In good health as determined by medical judgment and medical history
Exclusion
- Any food allergy/intolerance
- Subjects not willing and/or not able to comply with scheduled visits and the requirements of the study protocol
- Taking or anticipated initiation of any lipid-modifying or blood-clotting medication e.g. statins, cholesterol lowering
- Smokers
- 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
- Receiving or having received antibiotics in the past 4 weeks prior to the day of inclusion
- Overly imbalanced or restrictive diet (e.g. hyperproteic, vegan, ketogenic, etc.)
- Hormonal treatment for women linked to menopause (contraceptive treatment accepted)
- Pregnancy or breastfeeding
- Supplements or foods containing probiotics (yogurts allowed)
- Currently participating or having participated in another clinical trial within 4 weeks prior to trial start
Key Trial Info
Start Date :
February 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2021
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT04328571
Start Date
February 10 2020
End Date
September 15 2021
Last Update
October 1 2021
Active Locations (1)
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1
Universidad Católica San Antonio
Murcia, Spain, 30107