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Completed

NCT Number: NCT06298318

Metabolic Changes in Healthy Subjects with Acute Binge Drink

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.

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Key information

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310053, China

About this study

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:

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • male aged 18-30 years;
  • body mass index (BMI) ranging from 18.5 to 28 kg/m²;
  • having prior experience with binge drinking or hangovers, as assessed using the Personal Assessment of Maximum Drinking Capacity Survey Questionnaire

Exclusion criteria

  • with alcohol intolerance or alcohol dependence;
  • with serious health conditions, such as liver, kidney, cardiovascular, or gastrointestinal diseases;
  • vegetarians;
  • smokers;
  • with a history of drug use, including antihistamines, antihypertensives, antidiabetics, anxiolytics, and central nervous system depressants;
  • who had used antibiotics within two weeks prior to the trial;
  • who had consumed alcohol, alcoholic beverages or alcohol-containing foods within one week before the trial.

Treatment and study plan

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.

Water

Other

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

Primary outcomes

  1. hepatic function change

    Time frame: 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

  2. Hepatic fibrosis change

    Time frame: 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

  3. Lipid metabolism change

    Time frame: 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 outcomes

  1. Ethanol concentration

    Time frame: 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

  2. Acetaldehyde concentration

    Time frame: 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 outcomes

  1. Fecal metabolites

    Time frame: day1-2 of each 0 hour and 24 hours

    Gut microbial communities and their abundant features will be analysed based on shotgun metagenomic sequencing.

Sponsors and collaborators

Lead sponsor

Zhejiang Chinese Medical University

Other Gov

Registry information

Official study title

Effect of Acute Binge Drink Intervention on Healthy Young Subjects: a Double-blinded, Randomized Trial

Acronym: MeABD

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 7, 2024
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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