Efficacy and Safety of Alcovit in Reducing Blood Alcohol Concentration
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Alcovit® (Zeolite Clinoptilolite), Placebo.
- Who it may be relevant to
- Registry conditions: Alcohol Drinking, Blood Alcohol Content, Hangover. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Efficacy and Safety of Alcovit (Zeolite Clinoptilolite) in Reducing Blood Alcohol Concentration in Healthy Individuals
Overview
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.
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.
Primary outcome measures
- 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)]
- 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).]
Secondary outcome measures (10)
- 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)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Brazil · 1 center
- Hospital Santa Casa de Misericórdia de Campos — Campos dos Goytacazes
Identifiers
NCT: NCT07332429 · IGZ-06