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 (OleoMetS)

Apostolos Loukas Medical Centre Cyprus

Status: Completed

Conditions: Metabolic Syndrome

Treatments: Dietary Supplement: Olive Oil Polyphenol Supplement (OOPs, OLEOPROTECT®, Thousand Olives®); Dietary Supplement: Placebo capsules

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT07144488

EEBK/EP/2024/39

Details and patient eligibility

About

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

Enrollment: 106 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

-

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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106 participants in 2 patient groups, including a placebo group

Olive oil aldehydic phenols (OOPs) supplement

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Olive Oil Polyphenol Supplement (OOPs, OLEOPROTECT®, Thousand Olives®)

Placebo supplement

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo capsules