Adult Healthy VolunteersO-LIVENCT05852275
O-LIVE: Impact of a Portuguese Olive Oil in Health Biomarkers
A study testing Olive-oil in people with Adult Healthy Volunteers, run by Universidade Católica Portuguesa at 1 site in Portugal.
Trial summary
This research project, approved and funded, is part of a larger project, entitled "Healthy Soil for Food", which completes several work packages, one of which is a clinical research submitted to Ethics Committee entitled "O-LIVE: Impact of olive oil Portuguese in biomarkers of healthy volunteers". Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Adult Healthy Volunteers
- What is being tested?
- Olive-oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Sep 2022to 30 May 2023
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers
Who cannot join
- Current active infections
- Medications (Antidepressant medication, Antibiotics, anti-inflammatory, Angiotensin Converting Enzyme inhibitors, insulin and oral anti-diabetic medication)
- Dietary supplements (minerals and oligoelements, antioxidants, n-3 polyunsaturated fatty acids, n-6 polyunsaturated fatty acids, n-9 fatty acids)
- Presence of ant chronic/metabolic diseases:
- Diabetes
- Cancer
- Inflammatory diseases
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Escola Superior de Biotecnologia, Universidade Católica Portuguesa
Porto, 4169-005
Marta Correia, PhD, 00351912633095, mmcorreia@ucp.pt
Ana Maria Gomes, PhD, amgomes@ucp.pt
About this study
This research project, approved and funded, is part of a larger project, entitled "Healthy Soil for Food", which completes several work packages, one of which is a clinical research submitted to Ethics Committee entitled "O-LIVE: Impact of olive oil Portuguese in biomarkers of healthy volunteers".
The main objective of this work is to evaluate the impact of ingestion of an olive oil rich in polyphenols on clinical biomarkers and parameters, such as anthropometric measurements, on inflammatory gene expression regulation and on the composition of the intestinal microbiota.
Read the detailed description
Olive oil is an ancient product that is crucial for social cohesion and for local economies in the Mediterranean region, particularly in Portugal. There is ample evidence on the protective effect of olive oil in cardiovascular disease, diabetes, oncological diseases and neurological degeneration. Furthermore, olive oil has been shown to increase the rate of oxidation, inhibiting lipogenesis and stimulating lipolysis, in addition to affecting the expression of receptors involved in weight regulation and fat use.
These health benefits of olive oil derive from its specific nutritional composition, with monounsaturated fatty acids, polyphenols and phenolic compounds, which act on metabolism, modulation of inflammatory responses and gene expression. But the composition of olive oil can vary considerably depending on the type of cultivation of olive trees, soil management practices, as well as the extraction and technological processes involved in olive oil production.
In this work the investigators will use an olive oil rich in polyphenols (produced in a sustainable and local manner) and evaluate its effect on several important clinical parameters involved in chronic diseases. The investigators anticipate that the results of this work will help support the relationship between consuming higher polyphenol olive oil and improved overall health.
- Conditions
- Adult Healthy Volunteers
- Being tested
- Olive-oil
- Keywords
- Olive oil, inflammation, gut microbiota, Mediterranean Diet
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olive-oilOther
Participants will add to their usual diet a daily intake of 30 mL of an olive oil rich in polyphenols for 3-months (100 days)
| Study group | Role | What they receive |
|---|---|---|
| Olive oil arm | Experimental | Participants will include, in their usual diet, the daily intake of 30 mL of an olive oil rich in polyphenols (intervention group) for 100 days. At the beginning (day 1), in the middle (between days 50 and 60) and at the end of the intervention period (day 100), participants will be evaluated. Receives: Other: Olive-oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Body weight will be assessed using a scale
Measured: Day 1
Body weight
Body weight will be assessed using a scale
Measured: Day 50-60
Body weight
Body weight will be assessed using a scale
Measured: Day 100
Bacterial populations in fecal cultures
Bacterial populations in fecal cultures will be analysed by microbial DNA extraction and quantitative real-time polymerase-chain reaction (PCR) using specific primers.
Measured: Day 1
Bacterial populations in fecal cultures
Bacterial populations in fecal cultures will be analyzed by microbial DNA extraction and quantitative real-time polymerase-chain reaction (PCR) using specific primers.
Measured: Day 100
Inflammatory gene expression
Saliva sample will also be collected for subsequent DNA extraction and application of quantitative real-time PCR to determine the expression of inflammatory genes.
Measured: Day 1
Inflammatory gene expression
Saliva sample will also be collected for subsequent DNA extraction and application of quantitative real-time PCR to determine the expression of inflammatory genes.
Measured: Day 100
Body composition (% of fat mass and % of non-fat mass)
Body composition will be assessed using Body Impedance Analysis (body composition analyser)
Measured: Day 1
Body composition (% of fat mass and % of non-fat mass)
Body composition will be assessed using Body Impedance Analysis (body composition analyser)
Measured: Day 100
Adhesion to mediterranean diet
PREDIMED (PREvencion con Diet MEDiterranea) is a brief 14-item tool able to capture a strong monotonic inverse association between adherence to a good quality dietary pattern (Mediterranean diet) and obesity indexes in a population of adults (doi:10.1371/journal.pone.0043134)
Measured: Day 1
Adhesion to mediterranean diet
PREDIMED (PREvencion con Diet MEDiterranea) is a brief 14-item tool able to capture a strong monotonic inverse association between adherence to a good quality dietary pattern (Mediterranean diet) and obesity indexes in a population of adults (doi:10.1371/journal.pone.0043134)
Measured: Day 50-60
Adhesion to mediterranean diet
PREDIMED (PREvencion con DIeta MEDiterranea) is a brief 14-item tool able to capture a strong monotonic inverse association between adherence to a good quality dietary pattern (Mediterranean diet) and obesity indexes in a population of adults (doi:10.1371/journal.pone.0043134)
Measured: Day 100
Lipid profile serum level
A drop of blood will be analysed for biochemical parameters with point of care technology using a finger prick and analysed for total cholesterol, HDL, LDL and triacylglycerols
Measured: Day 1
Lipid profile serum level
A drop of blood will be analysed for biochemical parameters with point of care technology using a finger prick and analysed for total cholesterol, HDL, LDL and triacylglycerols
Measured: Day 100
C-reactive Protein serum level
A drop of blood will be analysed for biochemical parameters with point of care technology using a finger prick and analysed for PCR levels
Measured: Day 1
C-reactive Protein serum level
A drop of blood will be analysed for biochemical parameters with point of care technology using a finger prick and analysed for PCR levels
Measured: Day 100
glycated hemoglobin A1c serum levels
drop of blood will be analysed for biochemical parameters with point of care technology using a finger prick and analysed for levels glycated hemoglobin (ha1c)
Measured: Day 1
glycated hemoglobin A1c serum levels
drop of blood will be analysed for biochemical parameters with point of care technology using a finger prick and analysed for levels glycated hemoglobin (ha1c)
Measured: Day 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start1 Sep 2022
- Primary completion1 Mar 2023
- Study completion30 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This project consists of a quasi-experimental clinical study whose target population is healthy, voluntary adults. Participants will be recruited among men and women, aged 18 years or over, healthy, who belong to the community of the University (Portuguese Catholic University - Porto campus) and who do not meet any of the exclusion criteria. Individuals will be invited to participate voluntarily in this study, receiving detailed information about the investigation, in order to allow an informed, informed and free decision. Individuals who agree to participate sign an informed consent.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Católica Portuguesa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ana Gomes, PhD, Study director, Universidade Católica Portuguesa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852275
- Sponsor's protocol ID
- Project nº 171-CES/UCP
- Acronym
- O-LIVE
- Status last verified
- May 2023
- First submitted
- 5 Apr 2023
- Last updated
- 10 May 2023
- 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 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- O-LIVE: Impact of a Portuguese Olive Oil in Health Biomarkers
- ClinicalTrials.gov ID
- NCT05852275
- Acronym / sponsor ID
- O-LIVE / Project nº 171-CES/UCP
- Conditions
- Adult Healthy Volunteers
- Keywords
- Olive oil, inflammation, gut microbiota, Mediterranean Diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidade Católica PortuguesaUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 10 May 2023 (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 research project, approved and funded, is part of a larger project, entitled "Healthy Soil for Food", which completes several work packages, one of which is a clinical research submitted to Ethics Committee entitled "O-LIVE: Impact of olive oil Portuguese in biomarkers of healthy volunteers".
The main objective of this work is to evaluate the impact of ingestion of an olive oil rich in polyphenols on clinical biomarkers and parameters, such as anthropometric measurements, on inflammatory gene expression regulation and on the composition of the intestinal microbiota.
Detailed description
Olive oil is an ancient product that is crucial for social cohesion and for local economies in the Mediterranean region, particularly in Portugal. There is ample evidence on the protective effect of olive oil in cardiovascular disease, diabetes, oncological diseases and neurological degeneration. Furthermore, olive oil has been shown to increase the rate of oxidation, inhibiting lipogenesis and stimulating lipolysis, in addition to affecting the expression of receptors involved in weight regulation and fat use.
These health benefits of olive oil derive from its specific nutritional composition, with monounsaturated fatty acids, polyphenols and phenolic compounds, which act on metabolism, modulation of inflammatory responses and gene expression. But the composition of olive oil can vary considerably depending on the type of cultivation of olive trees, soil management practices, as well as the extraction and technological processes involved in olive oil production.
In this work the investigators will use an olive oil rich in polyphenols (produced in a sustainable and local manner) and evaluate its effect on several important clinical parameters involved in chronic diseases. The investigators anticipate that the results of this work will help support the relationship between consuming higher polyphenol olive oil and improved overall health.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This project consists of a quasi-experimental clinical study whose target population is healthy, voluntary adults. Participants will be recruited among men and women, aged 18 years or over, healthy, who belong to the community of the University (Portuguese Catholic University - Porto campus) and who do not meet any of the exclusion criteria. Individuals will be invited to participate voluntarily in this study, receiving detailed information about the investigation, in order to allow an informed, informed and free decision. Individuals who agree to participate sign an informed consent.
| Arm | Type | Receives |
|---|---|---|
| Olive oil arm | Experimental | Other: Olive-oilParticipants will include, in their usual diet, the daily intake of 30 mL of an olive oil rich in polyphenols (intervention group) for 100 days. At the beginning (day 1), in the middle (between days 50 and 60) and at the end of the intervention period (day 100), participants will be evaluated. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy volunteers
Key exclusion criteria (7 listed)
- Current active infections
- Medications (Antidepressant medication, Antibiotics, anti-inflammatory, Angiotensin Converting Enzyme inhibitors, insulin and oral anti-diabetic medication)
- Dietary supplements (minerals and oligoelements, antioxidants, n-3 polyunsaturated fatty acids, n-6 polyunsaturated fatty acids, n-9 fatty acids)
- Presence of ant chronic/metabolic diseases:
- Diabetes
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 |
|---|---|---|
| Olive-oilParticipants will add to their usual diet a daily intake of 30 mL of an olive oil rich in polyphenols for 3-months (100 days) | Other | Olive oil arm |
Primary outcome
Body weight
Time frame: Day 1
Body weight will be assessed using a scale
Body weight
Time frame: Day 50-60
Body weight will be assessed using a scale
Body weight
Time frame: Day 100
Body weight will be assessed using a scale
Bacterial populations in fecal cultures
Time frame: Day 1
Bacterial populations in fecal cultures will be analysed by microbial DNA extraction and quantitative real-time polymerase-chain reaction (PCR) using specific primers.
Bacterial populations in fecal cultures
Time frame: Day 100
Bacterial populations in fecal cultures will be analyzed by microbial DNA extraction and quantitative real-time polymerase-chain reaction (PCR) using specific primers.
Inflammatory gene expression
Time frame: Day 1
Saliva sample will also be collected for subsequent DNA extraction and application of quantitative real-time PCR to determine the expression of inflammatory genes.
Inflammatory gene expression
Time frame: Day 100
Saliva sample will also be collected for subsequent DNA extraction and application of quantitative real-time PCR to determine the expression of inflammatory genes.
Body composition (% of fat mass and % of non-fat mass)
Time frame: Day 1
Body composition will be assessed using Body Impedance Analysis (body composition analyser)
Body composition (% of fat mass and % of non-fat mass)
Time frame: Day 100
Body composition will be assessed using Body Impedance Analysis (body composition analyser)
Adhesion to mediterranean diet
Time frame: Day 1
PREDIMED (PREvencion con Diet MEDiterranea) is a brief 14-item tool able to capture a strong monotonic inverse association between adherence to a good quality dietary pattern (Mediterranean diet) and obesity indexes in a population of adults (doi:10.1371/journal.pone.0043134)
Adhesion to mediterranean diet
Time frame: Day 50-60
PREDIMED (PREvencion con Diet MEDiterranea) is a brief 14-item tool able to capture a strong monotonic inverse association between adherence to a good quality dietary pattern (Mediterranean diet) and obesity indexes in a population of adults (doi:10.1371/journal.pone.0043134)
Adhesion to mediterranean diet
Time frame: Day 100
PREDIMED (PREvencion con DIeta MEDiterranea) is a brief 14-item tool able to capture a strong monotonic inverse association between adherence to a good quality dietary pattern (Mediterranean diet) and obesity indexes in a population of adults (doi:10.1371/journal.pone.0043134)
Lipid profile serum level
Time frame: Day 1
A drop of blood will be analysed for biochemical parameters with point of care technology using a finger prick and analysed for total cholesterol, HDL, LDL and triacylglycerols
Lipid profile serum level
Time frame: Day 100
A drop of blood will be analysed for biochemical parameters with point of care technology using a finger prick and analysed for total cholesterol, HDL, LDL and triacylglycerols
C-reactive Protein serum level
Time frame: Day 1
A drop of blood will be analysed for biochemical parameters with point of care technology using a finger prick and analysed for PCR levels
C-reactive Protein serum level
Time frame: Day 100
A drop of blood will be analysed for biochemical parameters with point of care technology using a finger prick and analysed for PCR levels
glycated hemoglobin A1c serum levels
Time frame: Day 1
drop of blood will be analysed for biochemical parameters with point of care technology using a finger prick and analysed for levels glycated hemoglobin (ha1c)
glycated hemoglobin A1c serum levels
Time frame: Day 100
drop of blood will be analysed for biochemical parameters with point of care technology using a finger prick and analysed for levels glycated hemoglobin (ha1c)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
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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.
Ana Gomes, PhD study director
Universidade Católica Portuguesa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olive-oil in people with Adult Healthy Volunteers, run by Universidade Católica Portuguesa at 1 site in Portugal.
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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 10 May 2023. 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 Portugal. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marta Correia, PhD (00351912633095, mmcorreia@ucp.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: Day 1). The study lists 18 primary outcomes in all. 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 10 May 2023.