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| Name | Class |
|---|---|
| Fundacion IMIM | OTHER |
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The study is aimed at establishing the contribution of wine components on hydroxytyrosol body concentrations and biological effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Water | Placebo Comparator | Lemon-flavored water. 293 ml in pilot A, 147 ml in pilot B, 235 ml in pilot C, 147 ml in the definitive study. |
|
| Alcoholized wine | Active Comparator | Wine 13º in pilot A (293 ml), B (147 ml) and the definitive study (147 ml). Corresponding to 30 g of ethanol in pilot A, 15 g of ethanol in pilot B and 15 g of ethanol in the definitive study. Wine 8º in pilot C (235 ml). Corresponding to 15 g of ethanol. |
|
| De-alcoholized wine | Placebo Comparator | Wine 0º. Pilot A: 293ml; pilot B: 147 ml; pilot C: 235 ml; definitive study: 147 ml. Corresponding to 0 g of ethanol. |
|
| Ethanol | Active Comparator | Ethanol 13º in pilot A (293 ml), B (147 ml) and definitive study (147 ml). Corresponding to 30 g of ethanol in pilot A, 15 g of ethanol in pilot B and in the definitive study. Ethanol 8º in pilot C (235 ml). Corresponding to 15 g of ethanol. Ethanol was administered as a single dose of Vodka Absolut (40º) diluted in lemon-flavored water. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ethanol | Dietary Supplement | Vodka Absolut |
| |
| Water |
| Measure | Description | Time Frame |
|---|---|---|
| Hydroxytyrosol biological fluids concentrations | Hydroxytyrosol concentrations in plasma and urine | 0-24h after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Ethanol concentration | Ethanol blood concentrations | 0-6h after administration |
| Subjective drunkenness | Ethanol subjective effects measured using a visual analog scale |
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Inclusion Criteria:
Exclusion Criteria:
To be eligible, the subjects must agree to follow a poor polyphenols diet in the 72 hours prior to the start of each session and until 24 hours after.
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| Name | Affiliation | Role |
|---|---|---|
| Magí Farré, MD, PhD | Parc de Salut Mar | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parc de Salut Mar | Barcelona | Barcelona | 08003 | Spain |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| D014867 | Water |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 |
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| Other |
Lemon-flavored water |
|
| Alcoholized wine | Dietary Supplement | Wine 13º or wine 8º |
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| De-alcoholized wine | Dietary Supplement | Wine 0º |
|
| 0-6h after administration |
| Vital signs | Blood pressure, oral temperature and heart rate | 0-24h after administration |
| Ethanol metabolites concentrations | Ethanol metabolites recovery in urine | 0-24h after administration |
| Dopamine metabolites concentrations | Dopamine metabolites recovery in urine | 0-24h after administration |
| Oxidation biomarkers of proteins and lipids | 0-24h after administration |
| Psychomotor performance (DSST) | Psychomotor performance assessed by means of Digit symbol substitution test (DSST) | 0-6h after administration |
| Gene expression of genes related with receptors and regulators/oxidative stress and antioxidant defence | Baseline |
| Platelets monoamine oxidase-B activity | Baseline |
| Breath ethanol | Breath ethanol concentration | 30 min after administration |
| Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |