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OpenTrials
Completed

NCT Number: NCT07144488

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

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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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Apostolos Loukas Medical Centre Cyprus

Nicosia, Engomi, Cyprus

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 30-70 years with a diagnosis of MetS per International Diabetes Federation criteria were enrolled after informed consent.

Exclusion criteria

-

Treatment and study plan

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.

Other names: Olive oil aldehydic phenols (OOPs) supplement

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.

Primary outcomes

  1. Glycated haemoglobin

    Time frame: 12 weeks

    Change in HbA1c levels

  2. Fasting blood glucose

    Time frame: 12 weeks

    Change in fasting blood glucose levels

Secondary outcomes

  1. Lipid profile

    Time frame: 12 weeks

    Change in HDL, LDL, total cholesterol, triglycerides (mg/dL) and oxidised LDL

  2. Fatigue / Energy levels

    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).

Sponsors and collaborators

Lead sponsor

Apostolos Loukas Medical Centre Cyprus

Network

Collaborators

  • National and Kapodistrian University of Athens
  • University of Crete
  • University of Nicosia
  • Yale University

Registry information

Official study title

The Impact of Olive Oil Polyphenol Supplementation on Metabolic Syndrome Parameters

Acronym: OleoMetS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 27, 2025
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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