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Evaluation of the Efficacy and Safety of Alcovit (Zeolite Clinoptilolite) in Reducing Blood Alcohol Concentration in Healthy Individuals
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.
The product has extensive international experience, having been marketed in several countries (Germany, Poland, Romania, Russia, Australia, Mexico, Colombia, Croatia, United States, Ukraine and Sweden) over the past 15 years, totaling 1,387,500 sachets sold without reports of toxicity. The safety of clinoptilolite zeolite has been extensively evaluated by the European Food Safety Authority (EFSA) and by clinical trials, which confirmed its safety at typical food exposure levels, with no toxic side effects observed in humans or animals, even with prolonged use. Alcovit® is formulated as an effervescent powder for suspension presented in 15g sachets and intended for healthy adults who are occasional or moderate consumers of alcoholic beverages. The mechanism of action of Alcovit® is based on the ability of clinoptilolite zeolite to adsorb alcohol molecules in the stomach and small intestine, preventing their systemic absorption and promoting their natural elimination through the gastrointestinal tract.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
Yes
Hospital Santa Casa de Misericórdia de Campos
Campos dos Goytacazes, Rio de Janeiro, Brazil
Start Date
May 30, 2026
Primary Completion Date
May 30, 2026
Completion Date
May 30, 2027
Last Updated
January 12, 2026
228
ESTIMATED participants
Alcovit® (Zeolite Clinoptilolite)
DEVICE
Placebo
DEVICE
Lead Sponsor
Galzu Institute of Research, Teaching, Science and Applied Technology
Collaborators
NCT05692830
NCT06309134
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06994962