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| Name | Class |
|---|---|
| University of Nicosia | OTHER |
| University of Crete | OTHER |
| National and Kapodistrian University of Athens | OTHER |
| Yale University |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olive Oil Polyphenol Supplement (OOPs, OLEOPROTECT®, Thousand Olives®) | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Glycated haemoglobin | Change in HbA1c levels | 12 weeks |
| Fasting blood glucose | Change in fasting blood glucose levels | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Lipid profile | Change in HDL, LDL, total cholesterol, triglycerides (mg/dL) and oxidised LDL | 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). |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Apostolos Loukas Medical Centre Cyprus | Nicosia | Engomi | Cyprus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41429309 | Derived | 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. |
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| OTHER |
Randomized, double-blind, placebo-controlled, two-arm parallel-group study
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Both participants and study staff were blinded to group allocation. Placebo and active capsules were identical in appearance, weight, and taste
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| Placebo capsules | Dietary 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. |
|
| 12 weeks |
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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