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.
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);
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);
Parallel
Alcovit® (Zeolite Clinoptilolite)
DeviceEffervescent 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
DeviceEffervescent 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.
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.
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.
Correlation Between Blood Alcohol Reduction and Breathalyzer Readings
Correlation between the reduction in blood alcohol levels and breathalyzer (ethylometer) readings.
Correlation Between Elimination Rate in Blood and Breathalyzer
Correlation between the elimination rate of alcohol in blood and breathalyzer (ethylometer) readings.
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).
Participant Experience with Alcovit® (Patient-Reported Outcomes)
Participant experience with Alcovit® assessed by participant questionnaire.
Click on the lead sponsor to view all of their trials.
Galzu Institute of Research, Teaching, Science and Applied Technology
Lead sponsor
Hospital Santa Casa de Misericordia de Campos
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
