Efficacy and Safety of Alcovit in Reducing Blood Alcohol Concentration

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.

Inclusion criteria

• Healthy adults aged 18 to 70 years;
• Occasional or moderate alcohol consumers;
• Willing to abstain from alcohol and Alcovit® for a period established in the study;
• Voluntary willingness to participate in the study and sign the Informed Consent Form (ICF);
• Availability to comply with the study schedule.

Exclusion criteria

• History of alcohol use disorder (alcoholism) or abuse of other illicit substances;
• Hepatic, renal, gastrointestinal diseases, diabetes, and chronic conditions;
• Use of medications that interact with alcohol, including but not limited to: non-steroidal anti-inflammatory drugs (NSAIDs such as ibuprofen, diclofenac, naproxen), analgesics, antibiotics, antidepressants, benzodiazepines, anticoagulants, or any other medication that may interfere with alcohol metabolism or increase risks associated with alcohol consumption;
• Pregnancy or breastfeeding (beta-hCG test will be performed);
• Known allergy to any component of Alcovit® or placebo;
• Patients already enrolled in other clinical trials;
• Inability to provide free and informed consent;
• Any clinically significant medical condition or medical history that, in the investigator's opinion, may discourage participation in the study.