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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Bioavailability and Bioactivity of Olive Oils Enriched With Their Own Phenolic Compounds in a Dose-response Study (VOHF1)

Conditions
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Polyphenol Absorption in Healthy People

Intervention / Treatment
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* Other: olive oil


Participation Criteria
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Eligibility Criteria
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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 Anemia

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: FOO250<br>FOO250 ppm, the standard virgin olive oil | Other: olive oil<br>* 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.<br>* Other names: Functional olive oil;|
| Active Comparator: FOO500<br>Olive oil enriched with its own broad-spectrum phenolic compounds; FOO500 ppm | Other: olive oil<br>* 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.<br>* Other names: Functional olive oil;|
| Active Comparator: FOO750<br>Olive oil enriched with its own broad-spectra phenolic compounds; FOO750 ppm | Other: olive oil<br>* 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.<br>* Other names: Functional olive oil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Changes from baseline (pre-ingestion) in Bioavailability of phenolic compounds at 8h after olive oil intake | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Changes form baseline (pre-ingestion) at 6h or 8h after oral olive oil intake in bioactivity | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phenol-enriched olive oil, bioavailability, bioactivity