High Phenolic Olive Oil for Enhancing Metabolic Health: a Randomized-controlled Trial in Patients With cEntral Obesity (HOPE)
Key facts
- Where
- Kalamata, GreeceSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07445503, who can take part
Where in Greece
- Antikalamos Facilities of University of PeloponneseKalamata, GreeceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Peloponnese
- Trial code
- NCT07445503
- Record updated
- 3 March 2026
- Original description
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.Read full original descriptionShow less
High Phenolic Olive Oil for Enhancing Metabolic Health: a Randomized-controlled Trial in Patients With Central Obesity
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, and neurodegenerative disorders. Chronic low-grade inflammation and oxidative stress are key mechanisms underlying obesity-related metabolic disorders. Although dietary energy restriction remains the primary approach for weight management, growing research interest focuses on natural products rich in phenolic compounds as potential modulators of molecular pathways involved in central obesity.
However, robust clinical evidence in humans with central obesity and metabolic abnormalities remains limited. Therefore, this double-blind, randomized, controlled trial aims to investigate the effects of extra virgin, high-phenolic olive oil (HPOO) compared with low-phenolic olive oil (LPOO) in adults with overweight/obesity with metabolic abnormalities. Participants will consume the assigned olive oil type (HPOO or LPOO) for eight weeks.
At baseline and trial endpoint (8 weeks), data collection will include anthropometric measurements, dietary intake, biochemical indices, inflammatory and oxidative stress markers in blood samples, hormones, bioavailability of phenolic compounds, as well as lifestyle parameters i.e., health-related quality of life, physical activity levels, sleep quality. Ethical approval, informed consent, and data protection procedures will be strictly followed. Statistical analyses will be conducted using SPSS software (SPSS Inc, ΙΒΜ, Chicago, IL, USA).
The study is anticipated to explore whether consumption of high-phenolic olive oil favorably modulates markers related to obesity and metabolic abnormalities, while also improving nutritional status and quality-of-life parameters.
Inclusion: 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: Concomitant acute or chronic disease (e.g., infection, cancer, chronic heart failure, kidney disease, autoimmune diseases like rheumatoid arthritis, inflammatory bowel diseases, Hashimoto),; Drug and/or alcohol abuse,; Untreated diabetes,; Individuals with psychiatric or mental disorder,; Women at pregnancy or lactation,; Any use of antioxidant-phytochemical rich supplement, anti-, pre- or probiotics pre-intervention,; Those who did not consent or were unable to provide consent.