Efficacy and Safety of Alcovit in Reducing Blood Alcohol Concentration

Galzu Institute of Research, Teaching, Science and Applied Technology

Status: Begins enrollment in 3 months

Conditions: Blood Alcohol Content; Hangover; Alcohol Drinking

Treatments: Device: Alcovit® (Zeolite Clinoptilolite); Device: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07332429

IGZ-06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 228 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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228 participants in 4 patient groups, including a placebo group

Alcovit (Pre-consumption)

Experimental group

Description:

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

Treatment:

Device: Alcovit® (Zeolite Clinoptilolite)

Alcovit (Post-consumption)

Experimental group

Description:

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

Treatment:

Device: Alcovit® (Zeolite Clinoptilolite)

Placebo (Pre-consumption)

Placebo Comparator group

Description:

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

Treatment:

Device: Placebo

Placebo (Post-consumption)

Placebo Comparator group

Description:

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

Treatment:

Device: Placebo