Metabolic Changes in Healthy Subjects with Acute Binge Drink

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-27

Study Completion Date

2024-11-18

Brief Summary

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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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Detailed Description

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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.

Conditions

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Binge Drinking Liver Injury Hepatic Steatosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

not involve drug or biologic products

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

water

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Vodka

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

water

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes