A Phase 1 interventional study of Vodka and water in Binge Drinking, Liver Injury and Hepatic Steatosis, sponsored by Zhejiang Chinese Medical University. Completed at 1 site in China. Open to male participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-22.
Sponsored by Zhejiang Chinese Medical University · Phase 1, Interventional, and Basic science
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:
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:
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.
71 studies on the registry are indexed under Binge Drinking; 20 are open to participants now.
This study's enrollment of 40 is below the median of 120 across 64 interventional studies indexed under Binge Drinking.
Browse Binge Drinking studies →Zhejiang Chinese Medical University is the lead sponsor of 24 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: water
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.
Other: Vodka
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.
equal amount of non-alcoholic beverages with the same taste and colour but without alcohol
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
Time frame: 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
Time frame: 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
Time frame: day1-2 and of each 0 hour and 1hour and 5 hours and 12 hours and 24 hours
Ethanol concentration
Ethanol concentration change in mg/dL of each set
Time frame: 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
Time frame: day1-2 of each 0 hour and 1hour and 5hours and 12 hours and 24 hours
Fecal metabolites
Gut microbial communities and their abundant features will be analysed based on shotgun metagenomic sequencing.
Time frame: day1-2 of each 0 hour and 24 hours
Plan to share: No — Protect volunteers' personal health data and personal privacy
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Zhejiang Chinese Medical University