Alcohol DrinkingNCT07332429
Efficacy and Safety of Alcovit in Reducing Blood Alcohol Concentration
A study testing Alcovit® (Zeolite Clinoptilolite) in people with Alcohol Drinking and Blood Alcohol Content, run by Galzu Institute of Research, Teaching, Science and Applied Technology at 1 site in Brazil.
Trial 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®. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Blood Alcohol Content, Hangover
- What is being tested?
- Alcovit® (Zeolite Clinoptilolite)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- 1 siteBrazil
- Study dates
- 30 May 2026to 30 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Hospital Santa Casa de Misericórdia de Campos
Campos dos Goytacazes, Rio de Janeiro, 28035-053
Ailton X Silva, MD, +55 22 99985-7370, instiutogalzu@galzu.org.br
About this study
Official title: Evaluation of the Efficacy and Safety of Alcovit (Zeolite Clinoptilolite) in Reducing Blood Alcohol Concentration in Healthy Individuals
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?
Read more
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.
Read the 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
- Being tested
- Alcovit® (Zeolite Clinoptilolite), Placebo
- Keywords
- Zeolite Clinoptilolite, Alcovit, Alcohol Absorption, Medical Device, Hangover Prevention, Blood Alcohol Concentration
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcovit® (Zeolite Clinoptilolite)Device
Also called Alcovit (Pre-consumption), Alcovit (Post-consumption)
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.
PlaceboDevice
Also called Placebo (Pre-consumption), Placebo (Post-consumption)
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.
| Study group | Role | What they receive |
|---|---|---|
| Alcovit (Pre-consumption) | Experimental | Participants receive the investigational device immediately before (2-3 minutes) consuming the standardized alcohol dose. Receives: Device: Alcovit® (Zeolite Clinoptilolite) |
| Alcovit (Post-consumption) | Experimental | Participants receive the investigational device immediately after (maximum 5 minutes) consuming the standardized alcohol dose. Receives: Device: Alcovit® (Zeolite Clinoptilolite) |
| Placebo (Pre-consumption) | Placebo comparator | Participants receive the placebo immediately before consuming the standardized alcohol dose. Receives: Device: Placebo |
| Placebo (Post-consumption) | Placebo comparator | Participants receive the placebo immediately after consuming the standardized alcohol dose. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Correlation between the reduction in blood alcohol levels and breathalyzer (ethylometer) readings.
Measured: Baseline (30 minutes before), 20 minutes, 40 minutes, and 60 minutes after alcohol consumption (Day 1)
Correlation Between Elimination Rate in Blood and Breathalyzer
Correlation between the elimination rate of alcohol in blood and breathalyzer (ethylometer) readings.
Measured: Baseline (30 minutes before), 20 minutes, 40 minutes, and 60 minutes after alcohol consumption (Day 1).
Hangover Symptom Severity Using AHSS
Evaluation of Alcovit® efficacy in mitigating hangover symptoms using the total score and subdomains of the Alcohol Hangover Severity Scale (AHSS).
Measured: 24 hours after alcohol consumption (Day 1)
Participant Experience with Alcovit® (Patient-Reported Outcomes)
Participant experience with Alcovit® assessed by participant questionnaire.
Measured: Day 1 to Day 2
Adverse Events Reported by Participants (Clinician-Reported Outcomes)
Analysis of adverse events reported by participants.
Measured: Baseline (30 minutes before), 20 minutes, 40 minutes, and 60 minutes after alcohol consumption (Day 1)
Number and Type of Adverse Events (Clinician-Reported Outcomes)
Number and type of adverse events, unexpected adverse events, and serious adverse events.
Measured: Day 1 to Day 44 (6 weeks)
Changes in Hepatic Function Markers (Clinician-Reported Outcomes)
Changes in hepatic function between Alcovit® administration groups before and after alcohol ingestion (distilled and fermented beverages) compared to control for AST, ALT, GGT, alkaline phosphatase (ALP), total bilirubin and fractions.
Measured: Day 1 to Day 44 (6 weeks)
Changes in Renal Function Markers (Clinician-Reported Outcomes)
Changes in renal function between Alcovit® administration groups before and after alcohol ingestion (distilled and fermented beverages) compared to control for urea, creatinine, electrolytes, and urinalysis.
Measured: Day 1 to Day 44 (6 weeks)
Ease of Handling and Administration (Clinician-Reported Outcomes/Patient-Reported Outcomes)
Ease of handling and administration of Alcovit® assessed by questionnaire administered to nursing staff.
Measured: Day 1.
Baseline Population Characteristics (Clinician-Reported Outcomes)
Characterization of the study population and identification of potential confounding factors.
Measured: Day 1 (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start30 May 2026 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Galzu Institute of Research, Teaching, Science and Applied Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Santa Casa de Misericordia de Campos
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07332429
- Sponsor's protocol ID
- IGZ-06
- Status last verified
- Jan 2026
- First submitted
- 30 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect participant privacy and confidentiality in accordance with Brazilian data protection laws (LGPD - Lei Geral de Proteção de Dados) and ethical requirements. Study results will be published in aggregated form only.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Alcovit (Zeolite Clinoptilolite) in Reducing Blood Alcohol Concentration in Healthy Individuals
- ClinicalTrials.gov ID
- NCT07332429
- Acronym / sponsor ID
- IGZ-06
- Conditions
- Alcohol Drinking, Blood Alcohol Content, Hangover
- Keywords
- Zeolite Clinoptilolite, Alcovit, Alcohol Absorption, Medical Device, Hangover Prevention, Blood Alcohol Concentration
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Galzu Institute of Research, Teaching, Science and Applied TechnologyUniversity, hospital or other
- Collaborators
- Hospital Santa Casa de Misericordia de Campos
- Study start
- 30 May 2026 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Alcovit (Pre-consumption) | Experimental | Device: Alcovit® (Zeolite Clinoptilolite)Participants receive the investigational device immediately before (2-3 minutes) consuming the standardized alcohol dose. |
| Alcovit (Post-consumption) | Experimental | Device: Alcovit® (Zeolite Clinoptilolite)Participants receive the investigational device immediately after (maximum 5 minutes) consuming the standardized alcohol dose. |
| Placebo (Pre-consumption) | Placebo comparator | Device: PlaceboParticipants receive the placebo immediately before consuming the standardized alcohol dose. |
| Placebo (Post-consumption) | Placebo comparator | Device: PlaceboParticipants receive the placebo immediately after consuming the standardized alcohol dose. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcovit® (Zeolite Clinoptilolite)Also: Alcovit (Pre-consumption), Alcovit (Post-consumption)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 | Alcovit (Post-consumption), Alcovit (Pre-consumption) |
| PlaceboAlso: Placebo (Pre-consumption), Placebo (Post-consumption)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. | Device | Placebo (Post-consumption), Placebo (Pre-consumption) |
Primary outcome
Reduction in Blood Alcohol Levels and Breathalyzer Readings - Pre-consumption Administration
Time frame: Baseline (30 minutes before), 20 minutes, 40 minutes, and 60 minutes after alcohol consumption (Day 1)
Analysis of the reduction in blood alcohol levels and breathalyzer (ethylometer) readings in the Alcovit® group compared to the placebo group before alcohol consumption.
Reduction in Blood Alcohol Levels and Breathalyzer Readings - Post-consumption Administration
Time frame: Baseline (30 minutes before), 20 minutes, 40 minutes, and 60 minutes after alcohol consumption (Day 1).
Analysis of the reduction in blood alcohol levels and breathalyzer (ethylometer) readings in the Alcovit® group compared to the placebo group after alcohol consumption.
10 secondary outcomes
Correlation Between Blood Alcohol Reduction and Breathalyzer Readings
Time frame: Baseline (30 minutes before), 20 minutes, 40 minutes, and 60 minutes after alcohol consumption (Day 1)
Correlation Between Elimination Rate in Blood and Breathalyzer
Time frame: Baseline (30 minutes before), 20 minutes, 40 minutes, and 60 minutes after alcohol consumption (Day 1).
Hangover Symptom Severity Using AHSS
Time frame: 24 hours after alcohol consumption (Day 1)
Participant Experience with Alcovit® (Patient-Reported Outcomes)
Time frame: Day 1 to Day 2
Adverse Events Reported by Participants (Clinician-Reported Outcomes)
Time frame: Baseline (30 minutes before), 20 minutes, 40 minutes, and 60 minutes after alcohol consumption (Day 1)
Number and Type of Adverse Events (Clinician-Reported Outcomes)
Time frame: Day 1 to Day 44 (6 weeks)
Changes in Hepatic Function Markers (Clinician-Reported Outcomes)
Time frame: Day 1 to Day 44 (6 weeks)
Changes in Renal Function Markers (Clinician-Reported Outcomes)
Time frame: Day 1 to Day 44 (6 weeks)
Ease of Handling and Administration (Clinician-Reported Outcomes/Patient-Reported Outcomes)
Time frame: Day 1.
Baseline Population Characteristics (Clinician-Reported Outcomes)
Time frame: Day 1 (baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect participant privacy and confidentiality in accordance with Brazilian data protection laws (LGPD - Lei Geral de Proteção de Dados) and ethical requirements. Study results will be published in aggregated form only.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcovit® (Zeolite Clinoptilolite) in people with Alcohol Drinking and Blood Alcohol Content, run by Galzu Institute of Research, Teaching, Science and Applied Technology at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcelo P Coutinho, MD, PhD (+55 22 992266669, coutinho_doc@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Blood Alcohol Levels and Breathalyzer Readings - Pre-consumption Administration (time frame: Baseline (30 minutes before), 20 minutes, 40 minutes, and 60 minutes after alcohol consumption (Day 1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.