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

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

Conditions

• Metabolic Syndrome

Interventions

DIETARY_SUPPLEMENT

Olive 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_SUPPLEMENT

Placebo 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 & Collaborators

• University of Nicosia

  collaborator OTHER

• University of Crete

  collaborator OTHER

• National and Kapodistrian University of Athens

  collaborator OTHER

• Yale University

  collaborator OTHER

• Apostolos Loukas Medical Centre Cyprus

  lead NETWORK

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-01

Primary Completion

2025-01-01

Completion

2025-01-01

Countries

• Cyprus

Study Locations