Effects of Enzymatic Digestion and Probiotic on Oleuropein Bioavailability

September 30, 2021 updated by: Nestlé
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Murcia, Spain, 30107
        • Universidad Católica San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Dietary supplement: OLE enzymatically treated
OLE (Olive leaf extract ) enzymatically treated + maltodextrin
Experimental: OLE + probiotic
Participants will receive 1 capsule of OLE + 1 stick of probiotic each day in the morning for 21 days
Dietary supplement: OLE + probiotic
OLE (Olive leaf extract) co-administered with probiotic
Active Comparator: OLE
Participants will receive 1 capsule of OLE + 1 stick of maltodextrin each day in the morning for 21 days
Dietary supplement: OLE
OLE (Olive leaf extract) + maltodextrin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cmax during PK2 period
Time Frame: 24 hours
Cmax of total and individual oleuropein metabolites during PK2 period
24 hours
Tmax during PK2 period
Time Frame: 24 hours
Tmax of total and individual oleuropein metabolites during PK2 period
24 hours
T1/2 during PK2 period
Time Frame: 24 hours
T1/2 of total and individual oleuropein metabolites during PK2 period
24 hours
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
24 hours
AUC0-24h during PK1
Time Frame: 24 hours
AUC0-24h (concentration/time curve) of individual blood oleuropein metabolites during PK1 period
24 hours
Cmax during PK1
Time Frame: 24 hours
Cmax of total and individual blood oleuropein metabolites during PK1 period
24 hours
Tmax during PK1
Time Frame: 24 hours
Tmax of total and individual blood oleuropein metabolites during PK1 period
24 hours
T1/2 during PK1
Time Frame: 24 hours
T1/2 of total and individual blood oleuropein metabolites during PK1 period
24 hours
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
24 hours
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)
3 weeks
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
3 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of gut microbiota faecal short chain fatty acids
Time Frame: 3 weeks
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
Change of gut microbiota faecal branched chain fatty acids
Time Frame: 3 weeks
Change from baseline to end of the 3-week intervention period of gut microbiota faecal branched chain fatty acids (isobutyrate, isovalerate & isocaproate)
3 weeks
Change of gut microbiota faecal ammonium production
Time Frame: 3 weeks
Change from baseline to end of the 3-week intervention period of gut microbiota faecal ammonium production
3 weeks
Blood levels of total cholesterol
Time Frame: 3 weeks
Change from baseline to the end of the 3-week intervention period of total cholesterol levels
3 weeks
Blood levels of LDL
Time Frame: 3 weeks
Change from baseline to the end of the 3-week intervention period of LDL levels
3 weeks
Blood levels of HDL
Time Frame: 3 weeks
Change from baseline to the end of the 3-week intervention period of HDL levels
3 weeks
Blood levels of ALAT
Time Frame: 3 weeks
Change from baseline to the end of the 3-week intervention period of ALAT levels
3 weeks
Blood levels of ASAT
Time Frame: 3 weeks
Change from baseline to the end of the 3-week intervention period of ASAT levels
3 weeks
Blood levels of creatinine
Time Frame: 3 weeks
Change from baseline to the end of the 3-week intervention period of creatinine levels
3 weeks
Blood levels of glucose
Time Frame: 3 weeks
Change from baseline to the end of the 3-week intervention period of glucose levels
3 weeks
Blood levels of triglycerides
Time Frame: 3 weeks
Change from baseline to the end of the 3-week intervention period of triglycerides levels
3 weeks
Blood levels of bone biomarkers
Time Frame: 3 weeks
Change from baseline to the end of the 3-week intervention period of bone biomarkers (P1NP, CTX)
3 weeks
Blood levels of Oxidized LDL
Time Frame: 3 weeks
Change from baseline to the end of the 3-week intervention period of Oxidized LDL
3 weeks
Levels of biomarkers of oxidative stress
Time Frame: 3 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nestlé

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Francisco A. Tomás-Barberán, Prof., CEBAS-CSIC, Murcia, Spain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 10, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1907NRC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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