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

NCT07144488 | Completed

• 1 other identifier: EEBK/EP/2024/39
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (2)

• Glycated haemoglobin

  Change in HbA1c levels

  12 weeks

• Fasting blood glucose

  Change in fasting blood glucose levels

  12 weeks

Secondary Outcomes (2)

• Lipid profile

  12 weeks

• Fatigue / Energy levels

  12 weeks

Study Arms (2)

Olive oil aldehydic phenols (OOPs) supplement

EXPERIMENTAL

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.

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

Placebo supplement

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo capsules

Interventions

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.

Also known as: Olive oil aldehydic phenols (OOPs) supplement

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.

Placebo supplement

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Apostolos Loukas Medical Centre Cyprus: lead
• University of Nicosia: collaborator
• University of Crete: collaborator
• National and Kapodistrian University of Athens: collaborator
• Yale University: collaborator

Study Sites (1)

Apostolos Loukas Medical Centre Cyprus

Nicosia, Engomi, Cyprus

Location

Related Publications (1)

• Samoutis G, Kyriakides TC, Demetriou N, Poulianiti E, Samouti G, Samouti S, Diamantakos P, Melliou E, Magiatis P. The impact of olive oil polyphenol supplementation on metabolic syndrome parameters The OleoMetS study: A randomized, controlled clinical trial. Clin Nutr ESPEN. 2025 Dec 20;71:102883. doi: 10.1016/j.clnesp.2025.102883. Online ahead of print.

  PMID: 41429309 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both participants and study staff were blinded to group allocation. Placebo and active capsules were identical in appearance, weight, and taste
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, two-arm parallel-group study

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: August 27, 2025
• Study Start: September 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: August 27, 2025

Record last verified: 2025-08

Locations

CY (1)