Hepatic Steatosis Clinical Trial
— MeABDOfficial title:
Effect of Acute Binge Drink Intervention on Healthy Young Subjects: a Double-blinded, Randomized Trial
Verified date | April 2024 |
Source | Zhejiang Chinese Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Zhejiang Chinese Medical University | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Zhejiang Chinese Medical University |
China,
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
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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