Status:
COMPLETED
Intervention Study on Probiotic Combination Tableted Candy Hangover
Lead Sponsor:
Zhejiang University
Conditions:
Probiotic Combination Have the Potential to Improve Alcohol and Acetaldehyde in the Body After Drinking
The Potential of the Probiotics Combination Tablet on Alcohol Metabolism
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Study Design Type: Randomized, blinded, placebo-controlled, crossover trial Participants: 40 volunteers, divided into two groups (n=20) Grouping Method: Minimization randomization based on age and BMI...
Detailed Description
A randomized, blinded, placebo-controlled, crossover trial was conducted. Forty participants were divided into two groups (n=20). Then, for each block, randomization was performed by minimization by m...
Eligibility Criteria
Inclusion
- Age: 18-60 years old
- BMI: 18-25 kg/m2
- Healthy adults with experience of being drunk, fully understanding the experimental plan, and voluntarily agreeing to participate
- Able to tolerate a certain amount of alcohol (calculated as 60 kg, about 60 mL of 40-proof liquor)
- Must be able to swallow tablets
Exclusion
- People who are very intolerant to alcohol, with aldehyde dehydrogenase activity of 2%
- People with a history of allergic reactions or clinical allergic reactions to drugs, alcohol, products or other ingredients
- People who have taken drugs that induce and inhibit drug metabolizing enzymes, such as barbiturates, within one month from the date of the screening test
- People who have taken drugs that affect the results of clinical trials (alcohol metabolism) (aspirin, antipyretics, anti-inflammatory drugs, analgesics, antibiotics, herbal medicines, oral steroids, hormones, etc.) within 1 month from the screening population
- People who have taken drugs, products and functional foods that affect the intestines (such as probiotics, yogurt, etc.) within 10 days before the test
- People who have taken drugs, products or functional foods that have a functional effect on the stomach and liver within 10 days before the test
- People who have taken drugs, products or functional foods that have a functional effect on the stomach and liver within 10 days before the test. Those who have taken products that affect the test results, such as products or drugs that relieve alcohol, etc.
- Those who suffer from severe acute or chronic diseases such as cardiovascular disease, metabolic disease, hepatobiliary disease, pancreatic disease, muscle disease, nervous system disease, mental disorder, endocrine disease, immune disease, kidney disease, malignant tumor, lung disease and other diseases that require treatment
- Those who have received or are receiving clinically significant treatment for gastrointestinal diseases such as gastric or duodenal ulcers
- Those who have donated blood within 2 months from the date of screening
- Those whose serum AST, ALT or creatine kinase levels are higher than the reference range or twice the serum upper limit, and the creatinine level in the diagnostic test exceeds 2.0 mg/dL
- Those who are considered unsuitable due to diagnostic test results or other reasons.
Key Trial Info
Start Date :
October 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 6 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06883760
Start Date
October 17 2023
End Date
February 6 2024
Last Update
March 19 2025
Active Locations (1)
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1
ZJUT(Zhejiang University of Technology)
Hangzhou, Zhejiang, China, 313200