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

Phase 1

• Conditions: Polyphenol Absorption in Healthy People
• Interventions: Other: olive oil

• Registration Number: NCT01347515
• Lead Sponsor: University Rovira i Virgili

Brief Summary

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.

Detailed Description

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 Timeline

• Status Verified: 2011-04
• Study Start: 2011-04
• Study First Submitted: 2011-04-26
• Study First Submitted QC: 2011-05-03
• Study First Posted: 2011-05-04
• Last Update Submitted: 2011-05-27
• Last Update Posted: 2011-05-30
• Primary Completion: 2011-06
• Study Completion: 2011-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
FOO500	olive oil	Olive oil enriched with its own broad-spectrum phenolic compounds; FOO500 ppm
FOO250	olive oil	FOO250 ppm, the standard virgin olive oil
FOO750	olive oil	Olive oil enriched with its own broad-spectra phenolic compounds; FOO750 ppm

Primary Outcome Measures

Name	Time	Method
Changes in the dose-response study with olive oils (FOO250, FOO500 and FOO750) enriched with broad-spectrum phenolic compounds	Changes from baseline (pre-ingestion) in Bioavailability of phenolic compounds at 8h after olive oil intake	Bioavailability of phenolic compounds from olive oils in plasma and urine until 8h post olive oil-intake.

Secondary Outcome Measures

Name	Time	Method
Changes of bioactivity with olive oild (FOO250, FOO500 and FOO750)enriched with broad-spectrum phenolic compounds	Changes form baseline (pre-ingestion) in endothelial function of phenolic compounds at 6h after olive oil	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
Changes in bioactivity of FOO250, FOO500 and FOO750	Changes form baseline (pre-ingestion) at 6h or 8h after oral olive oil intake in bioactivity	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

Trial Locations

Locations (1)

Hospital Universitari Sant Joan, Universitat Rovira i Virgili; 🇪🇸 Reus, Tarragona, Spain