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| Name | Class |
|---|---|
| Fundacion IMIM | OTHER |
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Health benefits for humans derived from low dose intake of ethanol could partially be explained by its interaction with dopamine (DA) oxidative metabolism. Ethanol is expected to induce an increase in the formation of a DA minor metabolite: DOPET (hydroxytyrosol). Hydroxytyrosol is one of the most potent antioxidants present in Mediterranean Diet. The study is aimed at establishing the contribution of ethanol on hydroxytyrosol formation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Water | Placebo Comparator | Lemon-flavoured water (150 ml) |
|
| Ethanol high dose | Active Comparator | The high dose corresponds to 30 g of ethanol in pilot cohort 1, to 12 g of ethanol in pilot cohort 2 and to 42 g of ethanol in pilot cohort 3. For the definitive study the high dose corresponds to 30 g of ethanol. Ethanol was administered as a single dose of pure ethanol diluted in lemon-flavoured water (150 ml each beverage). |
|
| Ethanol low dose | Active Comparator | The low dose corresponds to 18 g of ethanol in pilot cohort 1, to 6 g of ethanol in pilot cohort 2 and to 24 g of ethanol in pilot cohort 3. For the definitive study the low dose corresponds to 18 g of ethanol. Ethanol was administered as a single dose of pure ethanol diluted in lemon-flavoured water (150 ml each beverage). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ethanol | Dietary Supplement |
| ||
| Water |
| Measure | Description | Time Frame |
|---|---|---|
| Hydroxytyrosol biological fluids concentrations | Hydroxytyrosol concentrations in plasma and urine | 0-24h after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective drunkenness | Ethanol subjective effects measured using a visual analog scale | 0-6h after administration |
| Vital signs | Blood pressure, oral temperature and heart rate |
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Inclusion Criteria:
Exclusion Criteria:
To be eligible, the subjects must agree to follow a diet free from ethanol and olive oil in the 72 hours prior to the start of each session and until the end of the study.
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| Name | Affiliation | Role |
|---|---|---|
| Magà Farré, MD, PhD | Parc de Salut Mar | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parc de Salut Mar | Barcelona | Barcelona | 08003 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25801942 | Derived | Perez-Mana C, Farre M, Pujadas M, Mustata C, Menoyo E, Pastor A, Langohr K, de la Torre R. Ethanol induces hydroxytyrosol formation in humans. Pharmacol Res. 2015 May-Jun;95-96:27-33. doi: 10.1016/j.phrs.2015.02.008. Epub 2015 Mar 20. |
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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 |
|
| 0-6h after administration |
| Ethanol concentration | Ethanol blood concentrations | 0-6h 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 |
| Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |