Bioavailability and Bioactivity of Olive Oils Enriched With Their Own Phenolic Compounds in a Dose-response Study (VOHF1)
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Changes in the dose-response study with olive oils (FOO250, FOO500 and FOO750) enriched with broad-spectrum phenolic compounds
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •healthy volunteers aged 20 to 70 years
Exclusion Criteria
- •LDL cholesterol levels above 189 mg/dL
- •Triglycerides ≥350 mg/dL (the upper limit for correctly determining LDL-c by the Friedewald formula)
- •Physical examination and routine biochemical laboratory determinations will be carried out to exclude co-morbidities
- •Intake of antioxidant supplement or acetylsalicylic acid or any other drug with known antioxidative properties
- •Chronic alcoholism
- •Body mass index (BMI)≥30 kg/m2
- •Statin treatment prior to initiating the trial; stopped at least 2 months before starting the study
- •Antihypertensive treatment prior to initiating the trial; stopped at least 2 months before starting the study
- •Diabetes mellitus (fasting blood glucose > 126 mg/dL; measurements repeated for confirmation)
- •Renal disease (plasma creatinine levels > 1.4 mg/dL for women and > 1.5 mg/dL for men
- •Acute infectious diseases, malignancies, severe liver insufficiency, chronic respiratory insufficiency or associated endocrine diseases
- •Other conditions with special nutritional requirements
- •Having participated in a clinical trial in the last 3 months, or currently participating in a clinical trial
- •Inability to continue in the study
- •History of gastrointestinal disease that can impair the absorption of nutrients
- •Depression syndrome or self-injuring ideation
- •High plasma C-reactive protein and ESR concentrations
- •Immunization in the last 2 months
Outcomes
Primary Outcomes
Changes in the dose-response study with olive oils (FOO250, FOO500 and FOO750) enriched with broad-spectrum phenolic compounds
Time Frame: 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 Outcomes
- 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)
- Changes in bioactivity of FOO250, FOO500 and FOO750(Changes form baseline (pre-ingestion) at 6h or 8h after oral olive oil intake in bioactivity)