Metabolic Changes in Healthy Subjects with Acute Binge Drink

NCT06298318 | Completed Phase 1

• 5 other identifiers: Acute Binge DrinkNSFC: 82273625ZCLY24H2602202410344043202410344075X
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Binge Drinking; Liver Injury; Hepatic Steatosis

Keywords

Acute alcohol intake; Liver

Outcome Measures

Primary Outcomes (3)

• hepatic function change

  Research blood hepatic function 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/LTBIL in μmol/L, direct bilirubin in μmol/L, indirect bilirubin in μmol/L, and total bile acid in μmol/L

  day1-2 of each 0 hour and 1hour and 5hours and 12 hours and 24 hours

• 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 of each 0 hour and 1hour and 5 hours and 12 hours and 24 hours

• 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 of each 0 hour and 1hour and 5 hours and 12 hours and 24 hours

Secondary Outcomes (2)

• Ethanol concentration

  day1-2 of each 0 hour and 1hour and 5hours and 12 hours and 24 hours

• Acetaldehyde concentration

  day1-2 of each 0 hour and 1hour and 5hours and 12 hours and 24 hours

Other Outcomes (1)

• Fecal metabolites

  day1-2 of each 0 hour and 24 hours

Study Arms (2)

Control group

PLACEBO COMPARATOR

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.

Other: water

vodka group

EXPERIMENTAL

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.

Other: Vodka

Interventions

Vodka 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.

vodka group

water OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• male aged 18-30 years;
• body mass index (BMI) ranging from 18.5 to 28 kg/m²;
• having prior experience with binge drinking or hangovers, as assessed using the Personal Assessment of Maximum Drinking Capacity Survey Questionnaire

You may not qualify if:

• with alcohol intolerance or alcohol dependence;
• with serious health conditions, such as liver, kidney, cardiovascular, or gastrointestinal diseases;
• vegetarians;
• smokers;
• with a history of drug use, including antihistamines, antihypertensives, antidiabetics, anxiolytics, and central nervous system depressants;
• who had used antibiotics within two weeks prior to the trial;
• who had consumed alcohol, alcoholic beverages or alcohol-containing foods within one week before the trial.

Sponsors & Collaborators

• Zhejiang Chinese Medical University: lead

Study Sites (1)

Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310053, China

Location

Related Publications (2)

• 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.

  PMID: 24458173 BACKGROUND

• 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.

  PMID: 28750942 BACKGROUND

MeSH Terms

Conditions

Binge Drinking; Fatty Liver

Interventions

Water

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol Drinking; Drinking Behavior; Behavior; Mental Disorders; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• guiiqin sun

  Zhejiang Chinese Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: not involve drug or biologic products

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: March 7, 2024
• Study Start: April 27, 2024
• Primary Completion: September 19, 2024
• Study Completion: November 18, 2024
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)