Efficacy and Safety of Alcovit in Reducing Blood Alcohol Concentration

NCT ID: NCT07332429

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 228 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-05-30
• Study Completion Date: 2027-05-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Alcovit (Pre-consumption)

Participants receive the investigational device immediately before (2-3 minutes) consuming the standardized alcohol dose.

Group Type: EXPERIMENTAL

Alcovit® (Zeolite Clinoptilolite)

Intervention Type: DEVICE

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.

Alcovit (Post-consumption)

Participants receive the investigational device immediately after (maximum 5 minutes) consuming the standardized alcohol dose.

Group Type: EXPERIMENTAL

Alcovit® (Zeolite Clinoptilolite)

Intervention Type: DEVICE

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 (Pre-consumption)

Participants receive the placebo immediately before consuming the standardized alcohol dose.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DEVICE

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.

Placebo (Post-consumption)

Participants receive the placebo immediately after consuming the standardized alcohol dose.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Alcovit (Pre-consumption); Alcovit (Post-consumption); Placebo (Pre-consumption); Placebo (Post-consumption)

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Santa Casa de Misericordia de Campos

UNKNOWN

Sponsor Role: collaborator

Galzu Institute of Research, Teaching, Science and Applied Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Santa Casa de Misericórdia de Campos

Campos dos Goytacazes, Rio de Janeiro, Brazil

Countries

Brazil

Central Contacts

Marcelo P Coutinho, MD, PhD

Role: CONTACT

coutinho_doc@hotmail.com

+55 22 992266669

Savio B Souza, PhD

Role: CONTACT

institutogalzu@galzu.org.br

+55 22 999857370

Facility Contacts

Ailton X Silva, MD

Role: primary

instiutogalzu@galzu.org.br

+55 22 99985-7370

Other Identifiers

IGZ-06

Identifier Type: -

Identifier Source: org_study_id