Healthy SubjectsNCT04328571
Effects of Enzymatic Digestion and Probiotic on Oleuropein Bioavailability
A study testing OLE enzymatically treated, OLE + probiotic and OLE in people with Healthy Subjects, run by Société des Produits Nestlé (SPN) at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- OLE enzymatically treated, OLE + probiotic and OLE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSpain
- Study dates
- 10 Feb 2020to 15 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- Capsule of OLE + 1 stick of maltodextrin
- Capsule of OLE enzymatically treated + 1 stick of maltodextrin
- 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:
- 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
- 3 weeks intervention (subjects will receive the product thy have benn assigned to) followed by a wash-out period of 3 days
- PK2 period (subjects will receive one capsule the product thy have benn assigned to
- Conditions
- Healthy Subjects
- Being tested
- OLE enzymatically treated, OLE + probiotic, OLE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OLE enzymatically treatedDietary supplement
OLE (Olive leaf extract ) enzymatically treated + maltodextrin
OLE + probioticDietary supplement
OLE (Olive leaf extract) co-administered with probiotic
OLEDietary supplement
OLE (Olive leaf extract) + maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| OLE enzymatically treated | Experimental | Participants will receive 1 capsule of OLE enzymatically treated + 1 stick of maltodextrin each day in the morning for 21 days Receives: Dietary Supplement: OLE enzymatically treated |
| OLE + probiotic | Experimental | Participants will receive 1 capsule of OLE + 1 stick of probiotic each day in the morning for 21 days Receives: Dietary Supplement: OLE + probiotic |
| OLE | Active comparator | Participants will receive 1 capsule of OLE + 1 stick of maltodextrin each day in the morning for 21 days Receives: Dietary Supplement: OLE |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-24h of individual blood oleuropein metabolites during PK2 period
AUC0-24h (concentration/time curve) of individual blood oleuropein metabolites during PK2 period
Measured: 24 hours
Secondary outcomes (11)
Cmax during PK2 period
Cmax of total and individual oleuropein metabolites during PK2 period
Measured: 24 hours
Tmax during PK2 period
Tmax of total and individual oleuropein metabolites during PK2 period
Measured: 24 hours
T1/2 during PK2 period
T1/2 of total and individual oleuropein metabolites during PK2 period
Measured: 24 hours
Levels of total and individual oleuropein metabolites in urine at PK2
Levels of total and individual oleuropein metabolites excreted in the urine collected over 24 hours during PK2
Measured: 24 hours
AUC0-24h during PK1
AUC0-24h (concentration/time curve) of individual blood oleuropein metabolites during PK1 period
Measured: 24 hours
Cmax during PK1
Cmax of total and individual blood oleuropein metabolites during PK1 period
Measured: 24 hours
Tmax during PK1
Tmax of total and individual blood oleuropein metabolites during PK1 period
Measured: 24 hours
T1/2 during PK1
T1/2 of total and individual blood oleuropein metabolites during PK1 period
Measured: 24 hours
Levels of total and individual oleuropein metabolites in urine at PK1
Levels of total and individual oleuropein metabolites excreted in the urine collected over 24 hours during PK1
Measured: 24 hours
Change in gut microbiota bacterial population diversity
Change from baseline to end of the 3-week intervention period of gut microbiota bacterial population diversity (16SrDNA sequencing)
Measured: 3 weeks
Change in levels of faecal oleuropein metabolites
Change from baseline to end of the 3-week intervention period of faecal oleuropein metabolites
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start10 Feb 2020
- Primary completion15 May 2021
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3-arms randomized-controlled, parallel group, single center, double-blinded study investigating 3 different formulations of the investigational product
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francisco A. Tomás-Barberán, Prof., Principal investigator, CEBAS-CSIC, Murcia, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328571
- Sponsor's protocol ID
- 1907NRC
- Status last verified
- Sep 2021
- First submitted
- 5 Mar 2020
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Enzymatic Digestion and Probiotic on Oleuropein Bioavailability
- ClinicalTrials.gov ID
- NCT04328571
- Acronym / sponsor ID
- 1907NRC
- Conditions
- Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 31 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Capsule of OLE + 1 stick of maltodextrin
- Capsule of OLE enzymatically treated + 1 stick of maltodextrin
- 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:
- 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
- 3 weeks intervention (subjects will receive the product thy have benn assigned to) followed by a wash-out period of 3 days
- PK2 period (subjects will receive one capsule the product thy have benn assigned to
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 3-arms randomized-controlled, parallel group, single center, double-blinded study investigating 3 different formulations of the investigational product
| Arm | Type | Receives |
|---|---|---|
| OLE enzymatically treated | Experimental | Dietary Supplement: OLE enzymatically treatedParticipants will receive 1 capsule of OLE enzymatically treated + 1 stick of maltodextrin each day in the morning for 21 days |
| OLE + probiotic | Experimental | Dietary Supplement: OLE + probioticParticipants will receive 1 capsule of OLE + 1 stick of probiotic each day in the morning for 21 days |
| OLE | Active comparator | Dietary Supplement: OLEParticipants will receive 1 capsule of OLE + 1 stick of maltodextrin each day in the morning for 21 days |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OLE enzymatically treatedOLE (Olive leaf extract ) enzymatically treated + maltodextrin | Dietary supplement | OLE enzymatically treated |
| OLE + probioticOLE (Olive leaf extract) co-administered with probiotic | Dietary supplement | OLE + probiotic |
| OLEOLE (Olive leaf extract) + maltodextrin | Dietary supplement | OLE |
Primary outcome
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
11 secondary outcomes
Cmax during PK2 period
Time frame: 24 hours
Tmax during PK2 period
Time frame: 24 hours
T1/2 during PK2 period
Time frame: 24 hours
Levels of total and individual oleuropein metabolites in urine at PK2
Time frame: 24 hours
AUC0-24h during PK1
Time frame: 24 hours
Cmax during PK1
Time frame: 24 hours
Tmax during PK1
Time frame: 24 hours
T1/2 during PK1
Time frame: 24 hours
Levels of total and individual oleuropein metabolites in urine at PK1
Time frame: 24 hours
Change in gut microbiota bacterial population diversity
Time frame: 3 weeks
Change in levels of faecal oleuropein metabolites
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco A. Tomás-Barberán, Prof. principal investigator
CEBAS-CSIC, Murcia, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OLE enzymatically treated, OLE + probiotic and OLE in people with Healthy Subjects, run by Société des Produits Nestlé (SPN) at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-24h of individual blood oleuropein metabolites during PK2 period (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2021.