Clinical trial NCT06298318: Metabolic Changes in Healthy Subjects with Acute Binge Drink
Official title: Effect of Acute Binge Drink Intervention on Healthy Young Subjects: a Double-blinded, Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Binge Drinking
Liver Injury
Hepatic Steatosis
Keywords: Acute alcohol intake
Liver
Lead sponsor: Zhejiang Chinese Medical University
Sponsor class: OTHER_GOV
First posted: 2024-03-07
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: not involve drug or biologic products
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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.

Eligibility 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.

Primary outcomes:
measure: hepatic function change
timeFrame: day1-2 of each 0 hour and 1hour and 5hours and 12 hours and 24 hours
measure: Hepatic fibrosis change
timeFrame: day1-2 of each 0 hour and 1hour and 5 hours and 12 hours and 24 hours
measure: Lipid metabolism change
timeFrame: day1-2 and of each 0 hour and 1hour and 5 hours and 12 hours and 24 hours
Secondary outcomes:
measure: Ethanol concentration
timeFrame: day1-2 of each 0 hour and 1hour and 5hours and 12 hours and 24 hours
measure: Acetaldehyde concentration
timeFrame: day1-2 of each 0 hour and 1hour and 5hours and 12 hours and 24 hours
Other outcomes:
measure: Fecal metabolites
timeFrame: day1-2 of each 0 hour and 24 hours
Locations:
city: Hangzhou
country: China
facility: Zhejiang Chinese Medical University
state: Zhejiang
Study officials:
affiliation: Zhejiang Chinese Medical University
name: guiiqin sun
role: STUDY_CHAIR
References:
citation: Lee MH, Kwak JH, Jeon G, Lee JW, Seo JH, Lee HS, Lee JH. Red ginseng relieves the effects of alcohol consumption and hangover symptoms in healthy men: a randomized crossover study. Food Funct. 2014 Mar;5(3):528-34. doi: 10.1039/c3fo60481k.
citation: Kim H, Kim YJ, Jeong HY, Kim JY, Choi EK, Chae SW, Kwon O. A standardized extract of the fruit of Hovenia dulcis alleviated alcohol-induced hangover in healthy subjects with heterozygous ALDH2: A randomized, controlled, crossover trial. J Ethnopharmacol. 2017 Sep 14;209:167-174. doi: 10.1016/j.jep.2017.07.028. Epub 2017 Jul 24.