A Randomized Crossover Trial on the Efficacy of Leuconostoc Mesenteroides (VITA-PB2) From Kimchi in Relieving Hangover Symptom
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Assessment of Hangover Severity (Score, 0-10) Using the Alcohol Hangover Severity Scale (AHSS)
研究概览
简要总结
Excessive alcohol intake can cause dehydration, digestive issues, oxidative stress, and hangover symptoms like headache and fatigue. Toxic metabolites like acetaldehyde and ROS contribute to liver damage. Chronic drinking activates harmful pathways like MEOS and increases inflammation. Gut-liver axis disruption also worsens hangovers. Probiotics, such as Leuconostoc mesenteroides, may help restore gut health and reduce toxicity, but more clinical research is needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged between 30 and 60 years
- •Body Mass Index (BMI) between 18.5 and 30 kg/m²
- •Individuals with a history of hangover experience
- •Adults with normal results in blood tests and vital signs
- •No organic gastrointestinal disease found in endoscopy within the past 3 months
- •Able to consume one bottle of soju within 30 minutes
- •Individuals who have personally signed the informed consent form
- •Individuals who have consumed excessive alcohol within the past week
- •Individuals who participated in a human clinical trial within the past month
- •Individuals taking supplements or medications that may affect alcohol metabolism
- •Individuals with alcohol metabolism disorders, diabetes, hypertension, gallstones, pancreatitis, gout, active tuberculosis, gastrointestinal bleeding or surgery, or those with kidney, liver (e.g., hepatitis B/C carriers, alcoholic liver disease), heart, lung, gastrointestinal, or neurological diseases
- •Pregnant women or those planning to become pregnant
- •Individuals who have taken liver function supplements or similar medications/health products within one month before the study
- •Individuals who consumed excessive alcohol within one week prior to study participation
- •Any other individuals deemed unsuitable for the study by the principal investigator
排除标准
- 未提供
结局指标
主要结局
Assessment of Hangover Severity (Score, 0-10) Using the Alcohol Hangover Severity Scale (AHSS)
时间窗: About 6 month
Hangover severity will be assessed using the Alcohol Hangover Severity Scale (AHSS), a validated self-reported questionnaire that rates symptoms such as headache, nausea, fatigue, and dizziness on a 0-10 Likert scale. Higher scores indicate greater hangover severity, allowing for standardized comparison between groups.
Change in Blood Aldehyde Dehydrogenase (ALDH) Activity (mU/mL) Over Time
时间窗: 6 month
Blood ALDH activity (mU/mL) was measured at 0, 0.5, 1, 2, and 4 hours following alcohol ingestion to evaluate the effect of VITA-PB2 supplementation on enzymatic metabolism of acetaldehyde. This outcome assesses potential group differences in ALDH activation as a marker of enhanced alcohol detoxification.
Change in Blood Ethanol (mg/dL) and Acetaldehyde (mg/dL) Levels Over Time
时间窗: 6 month
Blood concentrations of ethanol and acetaldehyde (mg/dL) were assessed at multiple time points (0, 0.5, 1, 2, and 4 hours) following alcohol ingestion to evaluate the effect of VITA-PB2 supplementation on alcohol metabolism. This outcome measure helps determine potential differences in the metabolic clearance of ethanol and acetaldehyde between the intervention and placebo groups.
次要结局
- Acute Hangover Scale (AHS) Total and Symptom-Specific Scores (0-7) After Alcohol Consumption(6 month)
- Serum Liver Enzyme Levels-AST (U/L), ALT (U/L), and GGT (U/L)-for Safety Evaluation Post Alcohol Ingestion(About 6 month)
- Plasma Reactive Oxygen Species (ROS; arbitrary units) and Nitrite (NO₂-; μM) Levels Following Alcohol Consumption(6 month)
研究者
Kyu Jae Lee
Prof.
Wonju Severance Christian Hospital