Efficacy and Safety of Alcovit in Reducing Blood Alcohol Concentration

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.

Conditions

• Alcohol Drinking
• Blood Alcohol Content
• Hangover

Interventions

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.

Sponsors & Collaborators

• Hospital Santa Casa de Misericordia de Campos

  collaborator UNKNOWN

• Galzu Institute of Research, Teaching, Science and Applied Technology

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-05-30

Primary Completion

2026-05-30

Completion

2027-05-30

Countries

• Brazil

Study Locations