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| Name | Class |
|---|---|
| Ministerio de Ciencia e InnovaciĂłn, Spain | OTHER_GOV |
| Universitat de Lleida | OTHER |
| Fundacion IMIM | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FOO250 | Placebo Comparator | FOO250 ppm, the standard virgin olive oil |
|
| FOO500 | Active Comparator | Olive oil enriched with its own broad-spectrum phenolic compounds; FOO500 ppm |
|
| FOO750 | Active Comparator | Olive oil enriched with its own broad-spectra phenolic compounds; FOO750 ppm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| olive oil | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rosa SolĂ , MD, PhD | Universitat Rovira i Virgili, Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Sant Joan, Universitat Rovira i Virgili | Recruiting | Reus | Tarragona | Catalunya | Spain |
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| ID | Term |
|---|---|
| D000069463 | Olive Oil |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| 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 |
| D005224 |
| Fats, Unsaturated |
| D010938 | Plant Oils |
| D009821 | Oils |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |