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High Phenolic Olive Oil for Enhancing Metabolic Health: a Randomized-controlled Trial in Patients With cEntral Obesity (HOPE)

RecruitingNAAges 18 Years - 80 YearsAllUniversity of Peloponnese
NCT07445503 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Olive oil is a fundamental component of the Mediterranean diet and a major source of monounsaturated fatty acids with well-established cardioprotective properties. When rich in phenolic compounds-such as hydroxytyrosol, tyrosol, oleuropein, oleocanthal, oleacein, and ligstroside aglycone-it is considered a functional food with antioxidant, anti-inflammatory, cardioprotective, chemoprotective, and neuroprotective effects. According to EU Regulation 432/2012, daily consumption of 20 g of extra virgin olive oil containing at least 5 mg of hydroxytyrosol and tyrosol derivatives (250 mg/kg) contributes to the protection of blood lipids from oxidative stress and qualifies for a health claim. Overweight/obesity, characterized by excessive fat accumulation, is strongly associated with non-communicable diseases, including cardiovascular disease, type 2 diabetes, hypertension, certain cancers, an

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adult men and women 18-80 years of age, * Overweight/obesity (body mass index \> 25 or waist circumference \>94 cm for males and \>80 cm for females), and * The presence of at least one of the following metabolic abnormality: (1) triglyceride level ≥150 mg/dL or HDL cholesterol ≤40 mg/dL in men and ≤50 mg/dL in women; (2) increased blood pressure ≥ 130/85 mm Hg; (3) elevated fasting blood sugar ≥100 mg/dL; (4) standardized drug treatment regimen, and * Provided signed informed consent for participation. Exclusion Criteria: * Concomitant acute or chronic disease (e.g., infection, cancer, chronic heart failure, kidney disease, autoimmune diseases like rheumatoid arthritis, inflammatory bowel diseases, Hashimoto), * Untreated diabetes, * Women at pregnancy or lactation, * Individuals with psychiatric or mental disorder, * Any use of antioxidant-phytochemical rich supplement, anti-, pre- or probiotics pre-intervention, * Drug and/or alcohol abuse, * Those who did not consent or were unable to provide consent.
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What it tests

  • Low phenolic olive oil
  • High phenolic olive oil
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Where

1 site
Antikalamos Facilities of University of Peloponnese
Kalamata, Greece
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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