Metabolic Changes in Healthy Subjects with Acute Binge Drink

Zhejiang Chinese Medical University40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Binge Drinking Liver Injury Hepatic Steatosis

Interventions

VodkaOTHER

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.

waterOTHER

equal amount of non-alcoholic beverages with the same taste and colour but without alcohol

Eligibility

Sex: MALEMin age: 18 YearsMax age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Zhejiang Chinese Medical University

Hangzhou, Zhejiang, China

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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