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| Name | Class |
|---|---|
| Ministerio de Sanidad, Servicios Sociales e Igualdad | OTHER_GOV |
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The main objective is to assess whether a natural inhibitor of aldehyde dehydrogenase 2 (ALDH2) contained in a soy extract could interfere on alcohol metabolism and effects in humans.
Soybeans contain isoflavones, which are biologically active polyphenols known as antioxidants and phytoestrogens. These isoflavones include daidzin, daidzein, genistin and glycitin, and have been implicated in the beneficial effects of soy consumption.
Daidzin and daidzein are isoflavones contained in soybean that can act as natural inhibitors of aldehyde dehydrogenase 2. Animal studies have demonstrated that some soy isoflavones can reduce the auto-administration of cocaine and suggest they might be useful to treat cocaine dependence.
Aldehyde dehydrogenase inhibitors, as disulfiram, are currently used in humans to treat alcohol dependence because they interfere with ethanol metabolism (specifically in the transformation of acetaldehyde to acetate.
Alcohol intake after disulfiram administration increases concentration of acetaldehyde in the blood (five to 10 times higher than that found during metabolism of the same amount of alcohol alone). The combination produced acute symptoms of a severe "hangover" (named disulfiram-like reaction), and the patient may experience symptoms as flushing of the skin, tachycardia, shortness of breath, nausea, vomiting, throbbing headache, visual disturbances, mental confusion, and in some cases severe reactions as postural syncope, and circulatory collapse.
In addition, disulfiram have demonstrated clinical efficacy in cocaine dependence. The mechanism of action for that effects are related to its ability to decrease dopamine degradation by inhibiting the dopamine-beta-hydroxylase enzyme (metabolizes dopamine to norepinephrine), and increasing its concentrations in some areas of the brain.
The aim of the study is to assess whether a soy extract containing isoflavones (daidzin, daidzein and genistein) could interfere on alcohol metabolism and produce adverse effects in humans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daidzin and alcohol | Experimental | Daidzin 80 mg, single dose, oral administration (4 capsules of Super-Absorbable Soy Isoflavones®). Alcohol 0.5 g/kg (vodka diluted in lemon-flavoured water), single dose, oral administration. Solution of 150 ml. |
|
| Alcohol | Active Comparator | Alcohol 0.5 g/kg (vodka diluted in lemon-flavoured water), single dose, oral administration. Solution of 150 ml. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daidzin | Dietary Supplement | Super-Absorbable Soy Isoflavones, LifeExtension, USA. Single oral dose of 4 capsules (containing 80 mg of daidzin-daidzein). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time curve (AUC 2-10h) | Calculation of AUC for blood alcohol concentrations | From 2h to 10h after the first administration |
| Measure | Description | Time Frame |
|---|---|---|
| Change in signs and symptoms of disulfiram-like reaction | Vital signs (heart rate, blood pressure, respiration rate, oral and facial temperature) and adverse effects measured by visual analogue scales (nausea, vomiting, vertigo, dizziness, headache, breathing difficulty, facial flushing) | From baseline to 10h after the first administration |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
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| ID | Term |
|---|---|
| C013908 | daidzin |
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Alcohol | Dietary Supplement | Alcohol single oral dose |
|
| Change in drunkenness and euphoria effects |
Drunkenness and euphoria will be measured by a visual analogue scale (VAS). |
| From baseline to 10h after the first administration |
| Area Under the Concentration-Time curve (AUC 0-10h) | Calculation of AUC of plasmatic concentrations of daidzein, genistein and equol | From baseline to 24h after the first administration |
| Number of participants with Serious and non-serious adverse events | Collection of adverse events spontaneously reported by the participants and/or observed by the investigators. | 3 days after each condition |
| Change in other subjective effects | Subjective effects will be measured with the Addiction Research Center Inventory (ARCI) | From baseline to 10h after the first administration |
| Elimination half-life | Calculation of elimination half-life from blood ethanol concentrations | From 2h to 10h after the first administration |
| Elimination half-life | Calculation of elimination half-life of plasmatic concentrations of daidzein, genistein and equol | From baseline to 24h after the first administration |
| Cumulative amount of drug excreted into urine up to collection time | Urine will be collected in the following periods:0-2h,2-8h,8-14h,14-24 h after administration. Concentrations of daidzein, genistein and equol will be measured | From baseline to 24h after the first administration |