Efficacy of Leuconostoc Mesenteroides

NCT07017088 | Completed

• 1 other identifier: EMB-2024-04
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Drinking; Alcohol Drinking Related Problems

Outcome Measures

Primary Outcomes (3)

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

  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.

  About 6 month

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

  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.

  6 month

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

  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.

  6 month

Secondary Outcomes (3)

• 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

Study Arms (1)

Single arm

EXPERIMENTAL

Single group Treatment

Dietary Supplement: Leuconostoc mesenteroides

Interventions

Leuconostoc mesenteroides DIETARY_SUPPLEMENT

Control vs Experiment

Single arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wonju Severance Christian Hospital: lead

Study Sites (1)

Prof. Kyu-Jae Lee

Wŏnju, Gangwon-do, 26426, South Korea

Location

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: June 12, 2025
• Study Start: August 13, 2024
• Primary Completion: September 13, 2024
• Study Completion: February 28, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)