Binge Drinking, Hepatic Steatosis, Liver Injury
Conditions
Keywords
Acute alcohol intake, Liver
Brief summary
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.
Detailed description
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.
Interventions
OTHERVodka
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.
OTHERwater
equal amount of non-alcoholic beverages with the same taste and colour but without alcohol
Sponsors
Zhejiang Chinese Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
not involve drug or biologic products
Eligibility
Sex/Gender
MALE
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
1. male aged 18-30 years; 2. body mass index (BMI) ranging from 18.5 to 28 kg/m²; 3. having prior experience with binge drinking or hangovers, as assessed using the Personal Assessment of Maximum Drinking Capacity Survey Questionnaire
Exclusion criteria
1. with alcohol intolerance or alcohol dependence; 2. with serious health conditions, such as liver, kidney, cardiovascular, or gastrointestinal diseases; 3. vegetarians; 4. smokers; 5. with a history of drug use, including antihistamines, antihypertensives, antidiabetics, anxiolytics, and central nervous system depressants; 6. who had used antibiotics within two weeks prior to the trial; 7. who had consumed alcohol, alcoholic beverages or alcohol-containing foods within one week before the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hepatic function change | day1-2 of each 0 hour and 1hour and 5hours and 12 hours and 24 hours | 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 |
| Hepatic fibrosis change | day1-2 of each 0 hour and 1hour and 5 hours and 12 hours and 24 hours | 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 |
| Lipid metabolism change | day1-2 and of each 0 hour and 1hour and 5 hours and 12 hours and 24 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ethanol concentration | day1-2 of each 0 hour and 1hour and 5hours and 12 hours and 24 hours | Ethanol concentration change in mg/dL of each set |
| Acetaldehyde concentration | day1-2 of each 0 hour and 1hour and 5hours and 12 hours and 24 hours | Acetaldehyde concentration change in mg/dL of each set |
Other
| Measure | Time frame | Description |
|---|---|---|
| Fecal metabolites | day1-2 of each 0 hour and 24 hours | Gut microbial communities and their abundant features will be analysed based on shotgun metagenomic sequencing. |
Countries
China
Outcome results
None listed