Evaluation of the Efficacy and Safety of Alcovit (Zeolite Clinoptilolite) in Reducing Blood Alcohol Concentration in Healthy Individuals
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Reduction in Blood Alcohol Levels and Breathalyzer Readings - Pre-consumption Administration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Alcovit (Pre-consumption)
Participants receive the investigational device immediately before (2-3 minutes) consuming the standardized alcohol dose.
干预措施: Alcovit® (Zeolite Clinoptilolite) (Device)
Alcovit (Post-consumption)
Participants receive the investigational device immediately after (maximum 5 minutes) consuming the standardized alcohol dose.
干预措施: Alcovit® (Zeolite Clinoptilolite) (Device)
Placebo (Pre-consumption)
Participants receive the placebo immediately before consuming the standardized alcohol dose.
干预措施: Placebo (Device)
Placebo (Post-consumption)
Participants receive the placebo immediately after consuming the standardized alcohol dose.
干预措施: Placebo (Device)
结局指标
主要结局
Reduction in Blood Alcohol Levels and Breathalyzer Readings - Pre-consumption Administration
时间窗: Baseline (30 minutes before), 20 minutes, 40 minutes, and 60 minutes after alcohol consumption (Day 1)
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
时间窗: Baseline (30 minutes before), 20 minutes, 40 minutes, and 60 minutes after alcohol consumption (Day 1).
Analysis of the reduction in blood alcohol levels and breathalyzer (ethylometer) readings in the Alcovit® group compared to the placebo group after alcohol consumption.
次要结局
- Correlation Between Blood Alcohol Reduction and Breathalyzer Readings(Baseline (30 minutes before), 20 minutes, 40 minutes, and 60 minutes after alcohol consumption (Day 1))
- Correlation Between Elimination Rate in Blood and Breathalyzer(Baseline (30 minutes before), 20 minutes, 40 minutes, and 60 minutes after alcohol consumption (Day 1).)
- Hangover Symptom Severity Using AHSS(24 hours after alcohol consumption (Day 1))
- Participant Experience with Alcovit® (Patient-Reported Outcomes)(Day 1 to Day 2)
- Adverse Events Reported by Participants (Clinician-Reported Outcomes)(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)(Day 1 to Day 44 (6 weeks))
- Changes in Hepatic Function Markers (Clinician-Reported Outcomes)(Day 1 to Day 44 (6 weeks))
- Changes in Renal Function Markers (Clinician-Reported Outcomes)(Day 1 to Day 44 (6 weeks))
- Ease of Handling and Administration (Clinician-Reported Outcomes/Patient-Reported Outcomes)(Day 1.)
- Baseline Population Characteristics (Clinician-Reported Outcomes)(Day 1 (baseline))