Efficacy and Safety of Alcovit in Reducing Blood Alcohol Concentration

Sponsor
Galzu Institute of Research, Teaching, Science and Applied Technology
Study ID
NCT07332429
Status
Not Yet Recruiting

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Conditions

  • Alcohol Drinking
  • Blood Alcohol Content
  • Hangover

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Alcovit® (Zeolite Clinoptilolite) — DEVICE
    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.
  • Placebo — DEVICE
    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 Details

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.

Key Dates

First listed
Jan 12, 2026
Start date
May 30, 2026
Status verified
Jan 2026
Primary completion
May 30, 2026
Completion
May 30, 2027

Study Design

Enrollment
228 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Alcovit (Pre-consumption)
    Participants receive the investigational device immediately before (2-3 minutes) consuming the standardized alcohol dose.
  • Experimental: Alcovit (Post-consumption)
    Participants receive the investigational device immediately after (maximum 5 minutes) consuming the standardized alcohol dose.
  • Placebo Comparator: Placebo (Pre-consumption)
    Participants receive the placebo immediately before consuming the standardized alcohol dose.
  • Placebo Comparator: Placebo (Post-consumption)
    Participants receive the placebo immediately after consuming the standardized alcohol dose.

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) ]

Central Contacts

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