Effect of Acute Binge Drink Intervention on Healthy Young Subjects: a Double-blinded, Randomized Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- hepatic function change
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •with alcohol intolerance or alcohol dependence;
- •with serious health conditions, such as liver, kidney, cardiovascular, or gastrointestinal diseases;
- •vegetarians;
- •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.
结局指标
主要结局
hepatic function change
时间窗: day1-2 of each 0 hour and 1hour and 5hours and 12 hours and 24 hours
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
Hepatic fibrosis change
时间窗: day1-2 of each 0 hour and 1hour and 5 hours and 12 hours and 24 hours
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
Lipid metabolism change
时间窗: day1-2 and of each 0 hour and 1hour and 5 hours and 12 hours and 24 hours
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
次要结局
- 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)
研究者
Li Lab,MD
Professor
Zhejiang Chinese Medical University