Intervention Study on Probiotic Combination Tableted Candy Hangover

Launched by ZHEJIANG UNIVERSITY · Mar 12, 2025

Keywords

ClinConnect Summary

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 matching age and body mass index (BMI). The two groups received different sequences of Probiotic combination intervention and maltodextrin intervention (placebo), coded as A and B to conceal their identities. Participants, data collectors, and data analysts were blinded throughout the study. Different researchers performed randomization, data collection, and data analysis.

The 40 volunteers rec...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.