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);
Galzu Institute of Research, Teaching, Science and Applied Technology
Lead sponsor
Hospital Santa Casa de Misericordia de Campos
Collaborator