Metabolic Changes in Healthy Subjects with Acute Binge Drink (MeABD)

January 16, 2025 updated by: Li Lab,MD, Zhejiang Chinese Medical University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310053
        • Zhejiang Chinese Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
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
equal amount of non-alcoholic beverages with the same taste and colour but without alcohol
Experimental: vodka group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
day1-2 of each 0 hour and 1hour and 5hours and 12 hours and 24 hours
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
day1-2 of each 0 hour and 1hour and 5 hours and 12 hours and 24 hours
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
day1-2 and of each 0 hour and 1hour and 5 hours and 12 hours and 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
day1-2 of each 0 hour and 1hour and 5hours and 12 hours and 24 hours
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
day1-2 of each 0 hour and 1hour and 5hours and 12 hours and 24 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
day1-2 of each 0 hour and 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Chinese Medical University

Investigators

  • Study Chair: guiiqin sun, Zhejiang Chinese Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2024

Primary Completion (Actual)

September 19, 2024

Study Completion (Actual)

November 18, 2024

Study Registration Dates

First Submitted

November 1, 2023

First Submitted That Met QC Criteria

February 29, 2024

First Posted (Actual)

March 7, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 16, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Acute Binge Drink
  • 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)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Protect volunteers' personal health data and personal privacy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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