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

Zhejiang Chinese Medical University

Status and phase: Completed; Phase 1

Conditions: Liver Injury; Hepatic Steatosis; Binge Drinking

Treatments: Other: Vodka; Other: water

Study type: Interventional

Funder types: Other

Identifiers

NCT06298318

NSFC: 82273625 (Other Grant/Funding Number)

202410344075X (Other Grant/Funding Number)

Acute Binge Drink

202410344043 (Other Grant/Funding Number)

ZCLY24H2602 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Male

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

40 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

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.

Treatment:

Other: water

vodka group

Experimental group

Description:

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.

Treatment:

Other: Vodka