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Completed

NCT Number: NCT07017088

Efficacy of Leuconostoc Mesenteroides

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.

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Key information

Conditions

Alcohol Drinking Alcohol Drinking Related Problems Behavior Drinking Behavior

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prof. Kyu-Jae Lee

Wŏnju, Gangwon-do, 26426, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Leuconostoc mesenteroides

Dietary Supplement

Control vs Experiment

Primary outcomes

  1. Assessment of Hangover Severity (Score, 0-10) Using the Alcohol Hangover Severity Scale (AHSS)

    Time frame: 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.

  2. Change in Blood Ethanol (mg/dL) and Acetaldehyde (mg/dL) Levels Over Time

    Time frame: 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.

  3. Change in Blood Aldehyde Dehydrogenase (ALDH) Activity (mU/mL) Over Time

    Time frame: 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.

Secondary outcomes

  1. Acute Hangover Scale (AHS) Total and Symptom-Specific Scores (0-7) After Alcohol Consumption

    Time frame: 6 month

    Hangover severity was evaluated using the Acute Hangover Scale (AHS), which assesses total and individual symptom scores (scale: 0 = none to 7 = incapacitating) across domains such as fatigue, headache, nausea, dizziness, and thirst. This measure was used to compare the impact of VITA-PB2 versus placebo on post-alcohol hangover symptoms.

  2. Serum Liver Enzyme Levels-AST (U/L), ALT (U/L), and GGT (U/L)-for Safety Evaluation Post Alcohol Ingestion

    Time frame: About 6 month

    To evaluate the hepatic safety profile of VITA-PB2 supplementation, serum levels of liver enzymes-AST, ALT, and GGT (U/L)-were measured at 0, 0.5, and 4 hours after alcohol intake. This assessment helps determine any potential hepatotoxic effects or alterations in liver function associated with the intervention.

  3. Plasma Reactive Oxygen Species (ROS; arbitrary units) and Nitrite (NO₂-; μM) Levels Following Alcohol Consumption

    Time frame: 6 month

    Plasma levels of reactive oxygen species (ROS) and nitrite (NO₂-), a stable metabolite reflecting nitric oxide (NO) production, were measured at multiple time points after alcohol ingestion to assess oxidative stress and NO signaling changes. This evaluation aimed to determine the antioxidant effects of VITA-PB2 supplementation in mitigating alcohol-induced oxidative damage.

Sponsors and collaborators

Lead sponsor

Wonju Severance Christian Hospital

Other

Registry information

Official study title

A Randomized Crossover Trial on the Efficacy of Leuconostoc Mesenteroides (VITA-PB2) From Kimchi in Relieving Hangover Symptom

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jun 12, 2025
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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