Metabolic Syndrome
Conditions
Brief 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, 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
Interventions
DIETARY_SUPPLEMENTOlive Oil Polyphenol Supplement (OOPs, OLEOPROTECT®, Thousand Olives®)
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.
DIETARY_SUPPLEMENTPlacebo capsules
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.
Sponsors
University of Nicosia
University of Crete
National and Kapodistrian University of Athens
Yale University
Apostolos Loukas Medical Centre Cyprus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Both participants and study staff were blinded to group allocation. Placebo and active capsules were identical in appearance, weight, and taste
Intervention model description
Randomized, double-blind, placebo-controlled, two-arm parallel-group study
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 30-70 years with a diagnosis of MetS per International Diabetes Federation criteria were enrolled after informed consent.
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycated haemoglobin | 12 weeks | Change in HbA1c levels |
| Fasting blood glucose | 12 weeks | Change in fasting blood glucose levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lipid profile | 12 weeks | Change in HDL, LDL, total cholesterol, triglycerides (mg/dL) and oxidised LDL |
| Fatigue / Energy levels | 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). |
Countries
Cyprus
Outcome results
None listed