Metabolic SyndromeOleoMetSNCT07144488
The Impact of Olive Oil Polyphenol Supplementation on Metabolic Syndrome Parameters: Preclinical Investigations Have Demonstrated That Olive Oil Polyphenols, Notably Oleocanthal, Oleacein, and Allied Secoiridoids, Possess Anti-inflammatory and Antioxidant Attributes
A study testing Olive Oil Polyphenol Supplement (OOPs, OLEOPROTECT®, Thousand Olives®) in people with Metabolic Syndrome, run by Apostolos Loukas Medical Centre Cyprus at 1 site in Cyprus.
Trial summary
Olive oil polyphenols, particularly oleocanthal, oleacein, and related secoiridoids, have shown anti-inflammatory and antioxidant properties in preclinical studies. Metabolic syndrome (MetS) is characterized by a constellation of risk factors, including central obesity, dyslipidemia, hypertension, and dysglycemia… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Olive Oil Polyphenol Supplement (OOPs, OLEOPROTECT®, Thousand Olives®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteCyprus
- Study dates
- 1 Sep 2024to 1 Jan 2025
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 30-70 years with a diagnosis of MetS per International Diabetes Federation criteria were enrolled after informed consent.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Olive Oil Polyphenol Supplementation on Metabolic Syndrome Parameters
Olive oil polyphenols, particularly oleocanthal, oleacein, and related secoiridoids, have shown anti-inflammatory and antioxidant properties in preclinical studies. Metabolic syndrome (MetS) is characterized by a constellation of risk factors, including central obesity, dyslipidemia, hypertension, and dysglycemia, which collectively contribute to a substantially elevated risk of cardiovascular disease (CVD) and type 2 diabetes mellitus (T2DM). Preclinical investigations have demonstrated that olive oil polyphenols, notably oleocanthal, oleacein, and allied secoiridoids, possess anti-inflammatory and antioxidant attributes.
The goal of this clinical trial is to learn if a polyphenol-rich olive oil extract works to improve metabolic syndrome (MetS) parameters in adults. It will also evaluate the safety of the supplement. The main questions it aims to answer are:
Read more
Does the olive oil extract improve fasting blood glucose and HbA1c levels?
How does the supplement affect other health measures such as cholesterol levels, inflammation (CRP), body mass index (BMI), blood pressure, waist size, liver function (ALT), kidney function (eGFR), uric acid levels, and fatigue?
Researchers will compare the olive oil extract supplement to a placebo (a look-alike substance with no active ingredients) to see if the supplement can help manage metabolic syndrome.
Participants will:
Take either 10 mg of the olive oil extract supplement or a placebo once daily for 12 weeks
Attend clinic visits for tests and checkups at the beginning and end of the study period
Have their blood sugar, cholesterol, inflammation markers, liver and kidney function, and other health parameters measured before and after the treatment
Complete questionnaires assessing fatigue levels
- Conditions
- Metabolic Syndrome
- Being tested
- Olive Oil Polyphenol Supplement (OOPs, OLEOPROTECT®, Thousand Olives®), Placebo capsules
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olive Oil Polyphenol Supplement (OOPs, OLEOPROTECT®, Thousand Olives®)Dietary supplement
Also called Olive oil aldehydic phenols (OOPs) supplement
Participants receive two capsules daily (total 10 mg/day) of a standardized olive oil polyphenol extract. Each capsule contains 5 mg of aldehydic phenols: 75% oleocanthal/oleacein and 25% oleuropein aglycon/ligstroside aglycon. Formulated with PEG400, cellulose, silicon dioxide, and magnesium stearate. Duration: 12 weeks.
Placebo capsulesDietary supplement
Two capsules taken daily for 12 weeks. Identical in weight, appearance, and taste to the active OOPs capsules. Contain PEG400, cellulose, silicon dioxide, and magnesium stearate, but no active olive oil polyphenols.
| Study group | Role | What they receive |
|---|---|---|
| Olive oil aldehydic phenols (OOPs) supplement | Experimental | Participants receive a daily dose of 10 mg OOPs supplement (2 capsules, each containing 5 mg polyphenols). The formulation consists of 75% oleocanthal/oleacein and 25% oleuropein aglycon/ligstroside aglycon. Receives: Dietary Supplement: Olive Oil Polyphenol Supplement (OOPs, OLEOPROTECT®, Thousand Olives®) |
| Placebo supplement | Placebo comparator | Participants receive 2 placebo capsules daily, identical in weight, appearance, and taste to the active supplement. Placebo contains PEG400, cellulose, silicon dioxide, and magnesium stearate, but no active olive oil polyphenols. Receives: Dietary Supplement: Placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated haemoglobin
Change in HbA1c levels
Measured: 12 weeks
Fasting blood glucose
Change in fasting blood glucose levels
Measured: 12 weeks
Secondary outcomes (2)
Lipid profile
Change in HDL, LDL, total cholesterol, triglycerides (mg/dL) and oxidised LDL
Measured: 12 weeks
Fatigue / Energy levels
Change from baseline in fatigue scores measured by the Energy Level Questionnaire (ELQ), which includes general, physical, and mental fatigue subscales. Each item is scored on a 5-point scale: Not at all, A little, Moderately, Quite a bit, Very much. Higher scores indicate greater fatigue (worse outcome).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start1 Sep 2024
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled, two-arm parallel-group study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apostolos Loukas Medical Centre Cyprus
- Sponsor type
- Research network
- Collaborators
- University of Nicosia, University of Crete, National and Kapodistrian University of Athens, Yale University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144488
- Sponsor's protocol ID
- EEBK/EP/2024/39
- Acronym
- OleoMetS
- Status last verified
- Aug 2025
- First submitted
- 18 Aug 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Samoutis G, Kyriakides TC, Demetriou N, Poulianiti E, Samouti G, Samouti S, Diamantakos P, Melliou E, Magiatis P. The impact of olive oil polyphenol supplementation on metabolic syndrome parameters The OleoMetS study: A randomized, controlled clinical trial. Clin Nutr ESPEN. 2026 Feb;71:102883. doi: 10.1016/j.clnesp.2025.102883. Epub 2025 Dec 20.
PubMed 41429309
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Olive Oil Polyphenol Supplementation on Metabolic Syndrome Parameters
- ClinicalTrials.gov ID
- NCT07144488
- Acronym / sponsor ID
- OleoMetS / EEBK/EP/2024/39
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Apostolos Loukas Medical Centre CyprusResearch network
- Collaborators
- University of Nicosia, University of Crete, National and Kapodistrian University of Athens, Yale University
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 27 Aug 2025 (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.
Olive oil polyphenols, particularly oleocanthal, oleacein, and related secoiridoids, have shown anti-inflammatory and antioxidant properties in preclinical studies. Metabolic syndrome (MetS) is characterized by a constellation of risk factors, including central obesity, dyslipidemia, hypertension, and dysglycemia, which collectively contribute to a substantially elevated risk of cardiovascular disease (CVD) and type 2 diabetes mellitus (T2DM). Preclinical investigations have demonstrated that olive oil polyphenols, notably oleocanthal, oleacein, and allied secoiridoids, possess anti-inflammatory and antioxidant attributes.
The goal of this clinical trial is to learn if a polyphenol-rich olive oil extract works to improve metabolic syndrome (MetS) parameters in adults. It will also evaluate the safety of the supplement. The main questions it aims to answer are:
Does the olive oil extract improve fasting blood glucose and HbA1c levels?
How does the supplement affect other health measures such as cholesterol levels, inflammation (CRP), body mass index (BMI), blood pressure, waist size, liver function (ALT), kidney function (eGFR), uric acid levels, and fatigue?
Researchers will compare the olive oil extract supplement to a placebo (a look-alike substance with no active ingredients) to see if the supplement can help manage metabolic syndrome.
Participants will:
Take either 10 mg of the olive oil extract supplement or a placebo once daily for 12 weeks
Attend clinic visits for tests and checkups at the beginning and end of the study period
Have their blood sugar, cholesterol, inflammation markers, liver and kidney function, and other health parameters measured before and after the treatment
Complete questionnaires assessing fatigue levels
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled, two-arm parallel-group study
| Arm | Type | Receives |
|---|---|---|
| Olive oil aldehydic phenols (OOPs) supplement | Experimental | Dietary Supplement: Olive Oil Polyphenol Supplement (OOPs, OLEOPROTECT®, Thousand Olives®)Participants receive a daily dose of 10 mg OOPs supplement (2 capsules, each containing 5 mg polyphenols). The formulation consists of 75% oleocanthal/oleacein and 25% oleuropein aglycon/ligstroside aglycon. |
| Placebo supplement | Placebo comparator | Dietary Supplement: Placebo capsulesParticipants receive 2 placebo capsules daily, identical in weight, appearance, and taste to the active supplement. Placebo contains PEG400, cellulose, silicon dioxide, and magnesium stearate, but no active olive oil polyphenols. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 30-70 years with a diagnosis of MetS per International Diabetes Federation criteria were enrolled after informed consent.
Key exclusion criteria (1 listed)
- -
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 Oil Polyphenol Supplement (OOPs, OLEOPROTECT®, Thousand Olives®)Also: Olive oil aldehydic phenols (OOPs) supplementParticipants receive two capsules daily (total 10 mg/day) of a standardized olive oil polyphenol extract. Each capsule contains 5 mg of aldehydic phenols: 75% oleocanthal/oleacein and 25% oleuropein aglycon/ligstroside aglycon. Formulated with PEG400, cellulose, silicon dioxide, and magnesium stearate. Duration: 12 weeks. | Dietary supplement | Olive oil aldehydic phenols (OOPs) supplement |
| Placebo capsulesTwo capsules taken daily for 12 weeks. Identical in weight, appearance, and taste to the active OOPs capsules. Contain PEG400, cellulose, silicon dioxide, and magnesium stearate, but no active olive oil polyphenols. | Dietary supplement | Placebo supplement |
Primary outcome
Glycated haemoglobin
Time frame: 12 weeks
Change in HbA1c levels
Fasting blood glucose
Time frame: 12 weeks
Change in fasting blood glucose levels
2 secondary outcomes
Lipid profile
Time frame: 12 weeks
Fatigue / Energy levels
Time frame: 12 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 27 Aug 2025.
- Derived from this study: PubMed 41429309Samoutis G, Kyriakides TC, Demetriou N, Poulianiti E, Samouti G, Samouti S, Diamantakos P, Melliou E, Magiatis P. The impact of olive oil polyphenol supplementation on metabolic syndrome parameters The OleoMetS study: A randomized, controlled clinical trial. Clin Nutr ESPEN. 2026 Feb;71:102883. doi: 10.1016/j.clnesp.2025.102883. Epub 2025 Dec 20.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Polyphenol Supplement (OOPs, OLEOPROTECT®, Thousand Olives®) in people with Metabolic Syndrome, run by Apostolos Loukas Medical Centre Cyprus at 1 site in Cyprus.
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 1 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 27 Aug 2025. 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 Cyprus. 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. Some participants in this study may receive a placebo. 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?
Glycated haemoglobin (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07144488, which also lists 1 linked publication.
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 27 Aug 2025.