NCT07445503 High Phenolic Olive Oil for Enhancing Metabolic Health: a Randomized-controlled Trial in Patients With cEntral Obesity (HOPE)
| NCT ID | NCT07445503 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Peloponnese |
| Condition | Adults |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-03-03 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2025-03-03 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Aristea Gioxari
PRINCIPAL INVESTIGATOR
Department of Nutritional Science and Dietetics, School of Health Sciences, University of Peloponnese
Frequently Asked Questions
Who can join the NCT07445503 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Adults. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07445503 currently recruiting?
Yes, NCT07445503 is actively recruiting participants. Contact the research team at a.gioxari@go.uop.gr for enrollment information.
Where is the NCT07445503 trial being conducted?
This trial is being conducted at Kalamata, Greece.
Who is sponsoring the NCT07445503 clinical trial?
NCT07445503 is sponsored by University of Peloponnese. The principal investigator is Aristea Gioxari at Department of Nutritional Science and Dietetics, School of Health Sciences, University of Peloponnese. The trial plans to enroll 80 participants.