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

University Rovira i Virgili

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Polyphenol Absorption in Healthy People

Treatments: Other: olive oil

Study type: Interventional

Funder types: Other

Identifiers

NCT01347515

URoviraiVirgili

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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12 participants in 3 patient groups, including a placebo group

FOO250

Placebo Comparator group

Description:

FOO250 ppm, the standard virgin olive oil

Treatment:

Other: olive oil

FOO500

Active Comparator group

Description:

Olive oil enriched with its own broad-spectrum phenolic compounds; FOO500 ppm

Treatment:

Other: olive oil

FOO750

Active Comparator group

Description:

Olive oil enriched with its own broad-spectra phenolic compounds; FOO750 ppm

Treatment:

Other: olive oil