Efficacy and Safety of Alcovit in Reducing Blood Alcohol Concentration

NCT07332429 | Not Yet Recruiting

• 1 other identifier: IGZ-06
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Drinking; Blood Alcohol Content; Hangover

Keywords

Zeolite Clinoptilolite; Alcovit; Alcohol Absorption; Medical Device; Hangover Prevention; Blood Alcohol Concentration

Outcome Measures

Primary Outcomes (2)

• Reduction in Blood Alcohol Levels and Breathalyzer Readings - Pre-consumption Administration

  Analysis of the reduction in blood alcohol levels and breathalyzer (ethylometer) readings in the Alcovit® group compared to the placebo group before alcohol consumption.

  Baseline (30 minutes before), 20 minutes, 40 minutes, and 60 minutes after alcohol consumption (Day 1)

• Reduction in Blood Alcohol Levels and Breathalyzer Readings - Post-consumption Administration

  Analysis of the reduction in blood alcohol levels and breathalyzer (ethylometer) readings in the Alcovit® group compared to the placebo group after alcohol consumption.

  Baseline (30 minutes before), 20 minutes, 40 minutes, and 60 minutes after alcohol consumption (Day 1).

Secondary Outcomes (10)

• Correlation Between Blood Alcohol Reduction and Breathalyzer Readings

  Baseline (30 minutes before), 20 minutes, 40 minutes, and 60 minutes after alcohol consumption (Day 1)

• Correlation Between Elimination Rate in Blood and Breathalyzer

  Baseline (30 minutes before), 20 minutes, 40 minutes, and 60 minutes after alcohol consumption (Day 1).

• Hangover Symptom Severity Using AHSS

  24 hours after alcohol consumption (Day 1)

• Participant Experience with Alcovit® (Patient-Reported Outcomes)

  Day 1 to Day 2

• Adverse Events Reported by Participants (Clinician-Reported Outcomes)

  Baseline (30 minutes before), 20 minutes, 40 minutes, and 60 minutes after alcohol consumption (Day 1)

Study Arms (4)

Alcovit (Pre-consumption)

EXPERIMENTAL

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

Device: Alcovit® (Zeolite Clinoptilolite)

Alcovit (Post-consumption)

EXPERIMENTAL

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

Device: Alcovit® (Zeolite Clinoptilolite)

Placebo (Pre-consumption)

PLACEBO COMPARATOR

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

Device: Placebo

Placebo (Post-consumption)

PLACEBO COMPARATOR

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

Device: Placebo

Interventions

Alcovit® (Zeolite Clinoptilolite) 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.

Also known as: Alcovit (Pre-consumption), Alcovit (Post-consumption)

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

Placebo 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.

Also known as: Placebo (Pre-consumption), Placebo (Post-consumption)

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galzu Institute of Research, Teaching, Science and Applied Technology: lead
• Hospital Santa Casa de Misericordia de Campos: collaborator

Study Sites (1)

Hospital Santa Casa de Misericórdia de Campos

Campos dos Goytacazes, Rio de Janeiro, 28035-053, Brazil

Location

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Central Study Contacts

Marcelo P Coutinho, MD, PhD

CONTACT

+55 22 992266669; coutinho_doc@hotmail.com

Savio B Souza, PhD

CONTACT

+55 22 999857370; institutogalzu@galzu.org.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Four parallel groups with 1:1:1:1 randomization comparing Alcovit® (zeolite clinoptilolite) versus placebo, administered at different time points relative to alcohol consumption. Group 1: Alcovit® administered 2-3 minutes before standardized alcohol intake. Group 2: Alcovit® administered within 5 minutes after completing alcohol intake. Group 3: Placebo administered 2-3 minutes before alcohol intake. Group 4: Placebo administered within 5 minutes after completing alcohol intake. Each participant remains in their assigned group throughout the study.

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 12, 2026
• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2027
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)