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| ID | Type | Description | Link |
|---|---|---|---|
| NSFC: 82273625 | Other Grant/Funding Number | National Natural Science Foundation of China | |
| ZCLY24H2602 | Other Grant/Funding Number | Natural Science Foundation of Zhejiang Province | |
| 202410344043 | Other Grant/Funding Number | National Project for Innovation and Entrepreneurship Training Program for College Students | |
| 202410344075X | Other Grant/Funding Number | National Project for Innovation and Entrepreneurship Training Program for College Students |
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The goal of this double-blinded, randomized trial is to investigate the effects of acute binge drinking on liver function, liver fat content, and lipid metabolism in healthy young subjects. The main questions it aims to answer are:
1. If acute binge drinking could alleviate liver injury and hepatic steatosis.
The goal of this double-blinded, randomized trial is to investigate the effects of acute binge drinking on liver function, liver fat content, and lipid metabolism in healthy young subjects. The main questions it aims to answer are:
1. If acute binge drinking could alleviate liver injury and hepatic steatosis.
Participants will be randomized into two groups (n=40) and provided vodka (1 g/kg body weight) or an equal amount of non-alcoholic beverages with the same taste and colour but without alcohol, respectively. 15 minutes later, they are successively provided with the same breakfast. Venous blood samples were collected at 0h, 1h, 3h, 5h, 6h, 12h, and 24h from each subject, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | BMI: if 18.5 ≤ BMI < 24.0, individuals received 1.0 g/kg body weight of water; if 24.0 ≤ BMI ≤ 28.0, individuals received 0.8 g/kg body weight of water. |
|
| vodka group | Experimental | BMI: if 18.5 ≤ BMI < 24.0, individuals received 1.0 g/kg body weight of vodka; if 24.0 ≤ BMI ≤ 28.0, individuals received 0.8 g/kg body weight of vodka. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vodka | Other | BMI: if 18.5 ≤ BMI < 24.0, individuals received 1.0 g/kg body weight of vodka; if 24.0 ≤ BMI ≤ 28.0, individuals received 0.8 g/kg body weight of vodka. |
|
| Measure | Description | Time Frame |
|---|---|---|
| hepatic function change | Research blood hepatic function include:Alanine Aminotransferase in U/L;Aspartate Aminotransferase in U/L;Gamma-Glutamyltransferase in U/L;Alpha-Fucosidase in U/L;Alkaline Phosphatase in U/L;cholinesterase in U/L;Lactate Dehydrogenase Enzyme in U/LTBIL in μmol/L, direct bilirubin in μmol/L, indirect bilirubin in μmol/L, and total bile acid in μmol/L | day1-2 of each 0 hour and 1hour and 5hours and 12 hours and 24 hours |
| Hepatic fibrosis change | Research blood hepatic fibrosis include:Hyaluronicacid in ng/mL;Laminin in ng/mL;type # in ng/mL;precollagen in ng/ mL;type # collagen in ng/mL;Fibronect in ng/mL | day1-2 of each 0 hour and 1hour and 5 hours and 12 hours and 24 hours |
| Lipid metabolism change | Research blood Fat metabolism include:Triglycerides in mmol/L;HDL-Cholesterol in mmol/L;LDL--Cholesterol in mmol/ L;Apolipoprotein A in mmol/L;Apolipoprotein B in mmol/L;Lipoprotein(a) in mmol/L | day1-2 and of each 0 hour and 1hour and 5 hours and 12 hours and 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Ethanol concentration | Ethanol concentration change in mg/dL of each set | day1-2 of each 0 hour and 1hour and 5hours and 12 hours and 24 hours |
| Acetaldehyde concentration | Acetaldehyde concentration change in mg/dL of each set |
| Measure | Description | Time Frame |
|---|---|---|
| Fecal metabolites | Gut microbial communities and their abundant features will be analysed based on shotgun metagenomic sequencing. | day1-2 of each 0 hour and 24 hours |
Inclusion Criteria:
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| guiiqin sun | Zhejiang Chinese Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Chinese Medical University | Hangzhou | Zhejiang | 310053 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24458173 | Background | Lee MH, Kwak JH, Jeon G, Lee JW, Seo JH, Lee HS, Lee JH. Red ginseng relieves the effects of alcohol consumption and hangover symptoms in healthy men: a randomized crossover study. Food Funct. 2014 Mar;5(3):528-34. doi: 10.1039/c3fo60481k. | |
| 28750942 | Background | Kim H, Kim YJ, Jeong HY, Kim JY, Choi EK, Chae SW, Kwon O. A standardized extract of the fruit of Hovenia dulcis alleviated alcohol-induced hangover in healthy subjects with heterozygous ALDH2: A randomized, controlled, crossover trial. J Ethnopharmacol. 2017 Sep 14;209:167-174. doi: 10.1016/j.jep.2017.07.028. Epub 2017 Jul 24. |
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Protect volunteers' personal health data and personal privacy
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| ID | Term |
|---|---|
| D063425 | Binge Drinking |
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D000428 | Alcohol Drinking |
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| ID | Term |
|---|---|
| D014867 | Water |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 |
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not involve drug or biologic products
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| water | Other | equal amount of non-alcoholic beverages with the same taste and colour but without alcohol |
|
| day1-2 of each 0 hour and 1hour and 5hours and 12 hours and 24 hours |
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |