Effects of Enzymatic Digestion and Probiotic on Oleuropein Bioavailability

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 15, 2020

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

Interventions

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

Arms, Groups and Cohorts

  • Experimental: OLE enzymatically treated
    • Participants will receive 1 capsule of OLE enzymatically treated + 1 stick of maltodextrin each day in the morning for 21 days
  • Experimental: OLE + probiotic
    • Participants will receive 1 capsule of OLE + 1 stick of probiotic each day in the morning for 21 days
  • Active Comparator: OLE
    • Participants will receive 1 capsule of OLE + 1 stick of maltodextrin each day in the morning for 21 days

Clinical Trial Outcome Measures

Primary Measures

  • AUC0-24h of individual blood oleuropein metabolites during PK2 period
    • Time Frame: 24 hours
    • AUC0-24h (concentration/time curve) of individual blood oleuropein metabolites during PK2 period

Secondary Measures

  • Cmax during PK2 period
    • Time Frame: 24 hours
    • Cmax of total and individual oleuropein metabolites during PK2 period
  • Tmax during PK2 period
    • Time Frame: 24 hours
    • Tmax of total and individual oleuropein metabolites during PK2 period
  • T1/2 during PK2 period
    • Time Frame: 24 hours
    • T1/2 of total and individual oleuropein metabolites during PK2 period
  • Levels of total and individual oleuropein metabolites in urine at PK2
    • Time Frame: 24 hours
    • Levels of total and individual oleuropein metabolites excreted in the urine collected over 24 hours during PK2
  • AUC0-24h during PK1
    • Time Frame: 24 hours
    • AUC0-24h (concentration/time curve) of individual blood oleuropein metabolites during PK1 period
  • Cmax during PK1
    • Time Frame: 24 hours
    • Cmax of total and individual blood oleuropein metabolites during PK1 period
  • Tmax during PK1
    • Time Frame: 24 hours
    • Tmax of total and individual blood oleuropein metabolites during PK1 period
  • T1/2 during PK1
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 3 weeks
    • Change from baseline to end of the 3-week intervention period of faecal oleuropein metabolites

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 25 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Nestlé
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Francisco A. Tomás-Barberán, Prof., Principal Investigator, CEBAS-CSIC, Murcia, Spain
  • Overall Contact(s)
    • Cecilia L. Fumero, +41 (0)21 785 8328, cecilia.fumero@rdls.nestle.com

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