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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | Single group Treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leuconostoc mesenteroides | Dietary Supplement | Control vs Experiment |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prof. Kyu-Jae Lee | Wŏnju | Gangwon-do | 26426 | South Korea |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
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| 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. | 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. | 6 month |