Effects of Enzymatic Digestion and Probiotic on Oleuropein Bioavailability

Nestlé

Status: Completed

Conditions: Healthy Subjects

Treatments: Dietary Supplement: OLE enzymatically treated; Dietary Supplement: OLE; Dietary Supplement: OLE + probiotic

Study type: Interventional

Funder types: Industry

Identifiers

NCT04328571

1907NRC

Details and patient eligibility

About

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.

Full 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

Enrollment: 104 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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104 participants in 3 patient groups

OLE enzymatically treated

Experimental group

Description:

Participants will receive 1 capsule of OLE enzymatically treated + 1 stick of maltodextrin each day in the morning for 21 days

Treatment:

Dietary Supplement: OLE enzymatically treated

OLE + probiotic

Experimental group

Description:

Participants will receive 1 capsule of OLE + 1 stick of probiotic each day in the morning for 21 days

Treatment:

Dietary Supplement: OLE + probiotic

OLE

Active Comparator group

Description:

Participants will receive 1 capsule of OLE + 1 stick of maltodextrin each day in the morning for 21 days

Treatment:

Dietary Supplement: OLE