NCT07332429

Efficacy and Safety of Alcovit in Reducing Blood Alcohol Concentration

Evaluation of the Efficacy and Safety of Alcovit (Zeolite Clinoptilolite) in Reducing Blood Alcohol Concentration in Healthy Individuals

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 228 (estimated)
• Sponsor: Galzu Institute of Research, Teaching, Science and Applied Technology · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Alcohol Drinking
• Blood Alcohol Content
• Hangover

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2026-05-30
• Primary completion: 2026-05-30
• Completion: 2027-05-30
• First posted: 2026-01-12
• Last updated: 2026-01-12

Locations

1 site across 1 country: Brazil