Apostolos Loukas Medical Centre Cyprus
Nicosia, Engomi, Cyprus
NCT Number: NCT07144488
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
Looking for future studies?
Notify Me30 year–70 year
All sexes
Interventional
Not applicable
Nicosia, Engomi, Cyprus
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-
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.
Other names: Olive oil aldehydic phenols (OOPs) 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.
Time frame: 12 weeks
Change in HbA1c levels
Time frame: 12 weeks
Change in fasting blood glucose levels
Time frame: 12 weeks
Change in HDL, LDL, total cholesterol, triglycerides (mg/dL) and oxidised LDL
Time frame: 12 weeks
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).
Apostolos Loukas Medical Centre Cyprus
Network
The Impact of Olive Oil Polyphenol Supplementation on Metabolic Syndrome Parameters
Acronym: OleoMetS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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