Alcohol DrinkingNCT07017088
Efficacy of Leuconostoc Mesenteroides
A study testing Leuconostoc mesenteroides in people with Alcohol Drinking and Alcohol Drinking Related Problems, run by Wonju Severance Christian Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Alcohol Drinking Related Problems
- What is being tested?
- Leuconostoc mesenteroides
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Aug 2024to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Crossover Trial on the Efficacy of Leuconostoc Mesenteroides (VITA-PB2) From Kimchi in Relieving Hangover Symptom
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.
- Being tested
- Leuconostoc mesenteroides
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leuconostoc mesenteroidesDietary supplement
Control vs Experiment
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Single group
Treatment Receives: Dietary Supplement: Leuconostoc mesenteroides |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 month
Secondary outcomes (3)
Acute Hangover Scale (AHS) Total and Symptom-Specific Scores (0-7) After Alcohol Consumption
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.
Measured: 6 month
Serum Liver Enzyme Levels-AST (U/L), ALT (U/L), and GGT (U/L)-for Safety Evaluation Post Alcohol Ingestion
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.
Measured: About 6 month
Plasma Reactive Oxygen Species (ROS; arbitrary units) and Nitrite (NO₂-; μM) Levels Following Alcohol Consumption
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.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start13 Aug 2024
- Primary completion13 Sep 2024
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wonju Severance Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyu Jae Lee, Wonju Severance Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017088
- Sponsor's protocol ID
- EMB-2024-04
- Status last verified
- May 2025
- First submitted
- 14 Apr 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Crossover Trial on the Efficacy of Leuconostoc Mesenteroides (VITA-PB2) From Kimchi in Relieving Hangover Symptom
- ClinicalTrials.gov ID
- NCT07017088
- Acronym / sponsor ID
- EMB-2024-04
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Wonju Severance Christian HospitalUniversity, hospital or other
- Study start
- 13 Aug 2024 (actual)
- Primary completion
- 13 Sep 2024 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Dietary Supplement: Leuconostoc mesenteroidesSingle group Treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leuconostoc mesenteroidesControl vs Experiment | Dietary supplement | Single arm |
Primary outcome
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.
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.
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.
3 secondary outcomes
Acute Hangover Scale (AHS) Total and Symptom-Specific Scores (0-7) After Alcohol Consumption
Time frame: 6 month
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
Plasma Reactive Oxygen Species (ROS; arbitrary units) and Nitrite (NO₂-; μM) Levels Following Alcohol Consumption
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leuconostoc mesenteroides in people with Alcohol Drinking and Alcohol Drinking Related Problems, run by Wonju Severance Christian Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Hangover Severity (Score, 0-10) Using the Alcohol Hangover Severity Scale (AHSS) (time frame: About 6 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.