Clinical trial NCT01347515: Bioactivity of Olive Oils Enriched With Their Own Phenolic Compounds (VOHF1)
Official title: Bioavailability and Bioactivity of Olive Oils Enriched With Their Own Phenolic Compounds in a Dose-response Study (VOHF1)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Polyphenol Absorption in Healthy People
Keywords: Phenol-enriched olive oil
bioavailability
bioactivity
Lead sponsor: University Rovira i Virgili
Sponsor class: OTHER
Collaborators: name: Ministerio de Ciencia e Innovación, Spain
name: Universitat de Lleida
name: Fundacion IMIM
First posted: 2011-05-04
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in the dose-response study with olive oils (FOO250, FOO500 and FOO750) enriched with broad-spectrum phenolic compounds
timeFrame: Changes from baseline (pre-ingestion) in Bioavailability of phenolic compounds at 8h after olive oil intake
Secondary outcomes:
measure: Changes of bioactivity with olive oild (FOO250, FOO500 and FOO750)enriched with broad-spectrum phenolic compounds
timeFrame: Changes form baseline (pre-ingestion) in endothelial function of phenolic compounds at 6h after olive oil
measure: Changes in bioactivity of FOO250, FOO500 and FOO750
timeFrame: Changes form baseline (pre-ingestion) at 6h or 8h after oral olive oil intake in bioactivity
Other outcomes:
Locations:
city: Reus
country: Spain
facility: Hospital Universitari Sant Joan, Universitat Rovira i Virgili
state: Tarragona
Study officials:
affiliation: Universitat Rovira i Virgili, Spain
name: Rosa Solà, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: