Clinical trial NCT07017088: Efficacy of Leuconostoc Mesenteroides
Official title: A Randomized Crossover Trial on the Efficacy of Leuconostoc Mesenteroides (VITA-PB2) From Kimchi in Relieving Hangover Symptom
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Alcohol Drinking Related Problems
Lead sponsor: Wonju Severance Christian Hospital
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion

* 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

Exclusion

* 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

Primary outcomes:
measure: Assessment of Hangover Severity (Score, 0-10) Using the Alcohol Hangover Severity Scale (AHSS)
timeFrame: About 6 month
measure: Change in Blood Ethanol (mg/dL) and Acetaldehyde (mg/dL) Levels Over Time
timeFrame: 6 month
measure: Change in Blood Aldehyde Dehydrogenase (ALDH) Activity (mU/mL) Over Time
timeFrame: 6 month
Secondary outcomes:
measure: Acute Hangover Scale (AHS) Total and Symptom-Specific Scores (0-7) After Alcohol Consumption
timeFrame: 6 month
measure: Serum Liver Enzyme Levels-AST (U/L), ALT (U/L), and GGT (U/L)-for Safety Evaluation Post Alcohol Ingestion
timeFrame: About 6 month
measure: Plasma Reactive Oxygen Species (ROS; arbitrary units) and Nitrite (NO₂-; μM) Levels Following Alcohol Consumption
timeFrame: 6 month
Other outcomes:
Locations:
city: Wonju
country: Korea, Republic of
facility: Prof. Kyu-Jae Lee
state: Kangwon-do
Study officials:
References: