Metabolic Changes in Healthy Subjects With Acute Binge Drink

Hepatic Steatosis Clinical Trial

— MeABD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06298318
• Other study ID #: Acute Binge Drink
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Binge Drinking
• Fatty Liver
• Hepatic Steatosis
• Liver Injury

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