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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06298318
Other study ID # Acute Binge Drink
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 27, 2024
Est. completion date July 18, 2026

Study information

Verified date April 2024
Source Zhejiang Chinese Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this double-blinded, randomized trial is to investigate the effects of acute binge drink 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 drink could alleviate liver injury and hepatic steatosis.


Description:

The goal of this double-blinded, randomized trial is to investigate the effects of acute binge drink 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 drink could alleviate liver injury and hepatic steatosis. Participants will be randomized into two groups (n=30), and provided vodka(1g/kg body weight) or equal amount of non-alcoholic beverages with the same taste and colour but without alcohol, respectively. 15 minutes later, they are successively provided with same breakfast . Venous blood are collected at 0h, 1h, 2h, 3h, 6h, 12h and 24h from each subject, respectively.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date July 18, 2026
Est. primary completion date July 19, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: - Sign informed consent Exclusion criteria - a. Neurological disorders - b. Alcohol allergy - c. Alcohol addiction - d. Gastrointestinal diseases - e. Liver, kidney, cardiovascular or systemic diseases - f. Antibiotics were administered within 2 weeks prior to the trial - g. Participants who ate a vegetarian diet - h. Unable to use a smartphone or computer with Internet access - i. Participate in another intervention study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
vodka
1g/kg body weight
water
equal amount of non-alcoholic beverages with the same taste and colour but without alcohol

Locations

Country Name City State
China Zhejiang Chinese Medical University Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Zhejiang Chinese Medical University

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Hepatic fibrosis change 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 and day 8-9 of each 0 hour and 1hour and 2 hours and 3 hours and 6 hours and 12 hours and 24 hours
Primary hepatic function change Research blood hepatic function include:TBIL in µmol/L;Direct bilirubin in µmol/L;Indirect bilirubin in µmol/L;Total bile acid in µmol/L day1-2 and day 8-9 of each 0 hour and 1hour and 2 hours and 3 hours and 6 hours and 12 hours and 24 hours
Primary hepatic injury change Research blood hepatic injury 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/L day1-2 and day 8-9 of each 0 hour and 1hour and 2 hours and 3 hours and 6 hours and 12 hours and 24 hours
Primary Lipid metabolism change 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 day 8-9 of each 0 hour and 1hour and 2 hours and 3 hours and 6 hours and 12 hours and 24 hours
Primary Laboratory markers of inflammation Research blood Inflammatory factor include:Interleukin-2 in pg/ml;Interleukin-4 in pg/ml;Interleukin-6 in pg/ ml;Interleukin-8 in pg/ml;Interleukin-10 in pg/ml;Tumor necrosis factor in pg/ml;Interferon gamma in pg/ml;Human IL-1 beta protein in pg/ml day1-2 and day 8-9 of each 0 hour and 1hour and 2 hours and 3 hours and 6 hours and 12 hours and 24 hours
Secondary Fecal metabolites Gut microbial communities and their abundant features will be analysed based on shotgun metagenomic sequencing. Time Frame: day1-2 and day 8-9 of each set
Secondary Ethanol concentration Ethanol concentration change in mg/dL of each set day1-2 and day 8-9 of each 0 hour and 1hour and 2 hours and 3 hours and 6 hours and 12 hours and 24 hours
Secondary Acetaldehyde concentration Acetaldehyde concentration change in mg/dL of each set day1-2 and day 8-9 of each 0 hour and 1hour and 2 hours and 3 hours and 6 hours and 12 hours and 24 hours
Secondary hangover cognition assessment tools after drinking The survey tool consisted of many questions addressing cognition headache, nausea,vomiting,fatigue,concentration,thirst or dehydration,light sensitivity,sleeping difficulty,excessive sweating,anxiety,feelings of depression,trembling or shaking,dizziness,stomachache,and memory loss after drinking day1-2 and day 8-9 of each 0 hour and 1hour and 2 hours and 3 hours and 6 hours and 12 hours and 24 hours
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