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Efficacy and Safety of Alcovit in Reducing Blood Alcohol Concentration
Sponsor: Galzu Institute of Research, Teaching, Science and Applied Technology
Summary
The goal of this clinical trial is to learn if Alcovit® (zeolite clinoptilolite) works to reduce blood alcohol concentration in healthy adults aged 18-70 years who are occasional or moderate alcohol consumers. It will also learn about the safety and tolerability of Alcovit®. The main questions it aims to answer are: * Does Alcovit® reduce blood alcohol concentration when administered before or after standardized alcoholic beverage consumption compared to placebo? * What is the rate of alcohol elimination from the blood (mg/dL/hour) in participants taking Alcovit® compared to placebo? * Is Alcovit® well tolerated when administered before or after alcohol consumption? Researchers will compare Alcovit® administered before alcohol consumption, Alcovit® administered after alcohol consumption, placebo administered before alcohol consumption, and placebo administered after alcohol consumption to see if Alcovit® effectively reduces blood alcohol levels. Participants will: * Consume a standardized alcoholic beverage under controlled conditions; * Take Alcovit® or a placebo either 2-3 minutes before or after (within 5 minutes) alcohol consumption; * Have blood samples collected at baseline (30 minutes before), and at 20, 40, and 60 minutes after alcohol consumption to measure blood alcohol concentration; * Complete breathalyzer (etilometer) measurements at the same time points; * Answer questionnaire to assess alcohol hangover severity; * Have safety blood tests performed to monitor liver and kidney function.
Official title: Evaluation of the Efficacy and Safety of Alcovit (Zeolite Clinoptilolite) in Reducing Blood Alcohol Concentration in Healthy Individuals
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
228
Start Date
2026-05-30
Completion Date
2027-05-30
Last Updated
2026-01-12
Healthy Volunteers
Yes
Interventions
Alcovit® (Zeolite Clinoptilolite)
Effervescent powder for oral suspension presented in 15g sachets, containing zeolite clinoptilolite (approximately 96% of the formulation) associated with B-complex vitamins (B1, B6, B12), vitamin C, and cupric chlorophyllin as natural colorant. The device is administered either immediately before alcohol consumption (2-3 minutes prior) or immediately after alcohol consumption (maximum 5 minutes after) depending on the assigned study arm.
Placebo
Effervescent powder for oral suspension presented in 15g sachets. Inert substance with identical appearance, taste, and texture to Alcovit®, but without the active ingredient (zeolite clinoptilolite). The placebo is administered either immediately before alcohol consumption (2-3 minutes prior) or immediately after alcohol consumption (maximum 5 minutes after) depending on the assigned study arm.
Locations (1)
Hospital Santa Casa de Misericórdia de Campos
Campos dos Goytacazes, Rio de Janeiro, Brazil