Bioactivity of Olive Oils Enriched With Their Own Phenolic Compounds (VOHF1)

University Rovira i Virgili12 enrolled

Overview

Hypothesis: A functional olive oil tailored to provide the best relationship between phenolic compounds (amount and type) phenolic bioavailability and bioactivity (antioxidant and anti-endothelial dysfunction) will be a useful tool for increasing not only circulating HDL cholesterol concentration, but also the functionality (antioxidant, anti-inflammatory, and reverse cholesterol transport capacity) of human HDL in vivo.

The first step is to determine, in healthy human subjects in postprandial condition, the best relationship between phenolic compounds (amount and type) / bioavailability and bioactivity (antioxidant, anti-inflammatory and anti-endothelial dysfunction) using olive oils enriched with its own broad-spectrum phenolic compounds.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Polyphenol Absorption in Healthy People

Interventions

olive oilOTHER

Each volunteer will be given, in random order, a single dose of 30 ml on a base of 80 g bread, of the following functional olive oils (FOO): FOO750 ppm, FOO500 ppm, which are enriched with two different amounts of broad-spectrum phenolic compounds from the virgin FOO250 ppm; all prepared at the Universitat de Lleida. Post-ingestion the volunteers will rest for 8h in a comfortable warm room. During the run-in period of 2 weeks prior the first postprandial study and 1 week between each FOO treatment period, all subjects will undergo a 2-day pre-treatment wash-out period of a phenol-free diet (saturated fatty acids in the diet will be 10-13% of energy in an isocaloric diet). Volunteers will avoid non-essential physical activity during the 3 days prior to the treatment day.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * healthy volunteers aged 20 to 70 years Exclusion Criteria: 1. LDL cholesterol levels above 189 mg/dL 2. Triglycerides ≥350 mg/dL (the upper limit for correctly determining LDL-c by the Friedewald formula) 3. Physical examination and routine biochemical laboratory determinations will be carried out to exclude co-morbidities 4. Intake of antioxidant supplement or acetylsalicylic acid or any other drug with known antioxidative properties 5. Chronic alcoholism 6. Body mass index (BMI)≥30 kg/m2 7. Statin treatment prior to initiating the trial; stopped at least 2 months before starting the study 8. Antihypertensive treatment prior to initiating the trial; stopped at least 2 months before starting the study 9. Diabetes mellitus (fasting blood glucose \> 126 mg/dL; measurements repeated for confirmation) 10. Renal disease (plasma creatinine levels \> 1.4 mg/dL for women and \> 1.5 mg/dL for men 11. Acute infectious diseases, malignancies, severe liver insufficiency, chronic respiratory insufficiency or associated endocrine diseases 12. Other conditions with special nutritional requirements 13. Having participated in a clinical trial in the last 3 months, or currently participating in a clinical trial 14. Inability to continue in the study 15. History of gastrointestinal disease that can impair the absorption of nutrients 16. Depression syndrome or self-injuring ideation 17. High plasma C-reactive protein and ESR concentrations 18. Immunization in the last 2 months 19. Anemia

Locations (1)

Hospital Universitari Sant Joan, Universitat Rovira i Virgili

Reus, Tarragona, Spain

RECRUITING

Outcomes

Primary Outcomes

Changes in the dose-response study with olive oils (FOO250, FOO500 and FOO750) enriched with broad-spectrum phenolic compounds

Bioavailability of phenolic compounds from olive oils in plasma and urine until 8h post olive oil-intake.

Time frame: Changes from baseline (pre-ingestion) in Bioavailability of phenolic compounds at 8h after olive oil intake

Secondary Outcomes

Changes of bioactivity with olive oild (FOO250, FOO500 and FOO750)enriched with broad-spectrum phenolic compounds

Endothelial function will be measured through the assessment of ischemic reactive hyperemia (IRH), at baseline and at 2h, 4 h and 6 after olive oil intake

Time frame: Changes form baseline (pre-ingestion) in endothelial function of phenolic compounds at 6h after olive oil

Changes in bioactivity of FOO250, FOO500 and FOO750

Biomarkers of cardiovascular disease: Oxidative; Lipid profile; Insulin resistance; Inflammation biomarkers; Endothelial dysfunction; Anti-thrombotic activity; Identification and quantification in human plasma and in urine of phenol metabolites

Time frame: Changes form baseline (pre-ingestion) at 6h or 8h after oral olive oil intake in bioactivity

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.