Rapid Blood Alcohol Concentration Reduction with Nutraceutical Blend Study
Medical Life Care Planners, LLC
Summary
Study Title: Nutritional Supplement to Rapidly Decrease Blood Alcohol Concentration (BAC): Safety and Efficacy Study Design: Double-blind, randomized, placebo-controlled clinical trial Objective: Evaluate safety and efficacy of a nutritional supplement to rapidly decrease blood alcohol concentration (BAC), alcohol-induced impairment, and hangover symptoms after excessive alcohol consumption. Primary Outcomes: BAC reduction rate/extent (BACtrack S80™ breathalyzer) Cognitive/physical impairment change (DRUID app™) Secondary Outcome: Hangover symptom reduction (Acute Hangover Scale) Participants: 35 participants, recruited via social media Duration: 2 weeks, 2 testing sessions (4 hours each) Location: Closed facility in St. Petersburg, FL Procedure: Subjects consume standardized alcohol (1g ethanol/kg body weight) 40-minute drinking period BAC and impairment measurements Administration of test formulation or placebo Measurements: BAC: Baseline, 40min, 15min, 30min, 60min, 90min post-drinking Impairment: Baseline, 15min, 30min, 60min post-drinking Hangover: Next morning via text message Safety Measures: GRAS ingredients Lab testing of formulations Medical screening Adverse effect questionnaires Pregnancy tests BAC \<0.08% before leaving Key Features: Paired measurements: active vs. placebo for mini-drink and capsule formulations Uber transportation provided Strict inclusion/exclusion criteria Data Analysis: Electronic data entry Blinded submission for statistical analysis Paired comparisons and multiple statistical tests This study aims to provide robust data on the efficacy in mitigating alcohol's effects, potentially offering a new tool for reducing alcohol-related impairment and hangover symptoms. The design prioritizes safety, consistency, and scientific rigor to ensure reliable results.
Description
Study Title: Nutraceutical Safety and Efficacy Study Introduction: The nutraceutical Safety and Efficacy Study is a comprehensive clinical trial designed to evaluate a novel formulation aimed at rapidly decreasing blood alcohol concentration (BAC), alcohol-induced impairment, and veisalgia (hangover) symptoms following excessive alcohol consumption. This study addresses a significant public health concern by potentially offering a method to mitigate the negative effects of alcohol overconsumption. Study Design: This is a triple-blinded, randomized, placebo-controlled clinical trial. The tr…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Over age 21 * Provide signed Informed Consent form electronically in advance of the first study date. * Provided signed Acknowledgement Form of what is required as part of the study, including use of Uber for transportation to and from each session. * Not taking certain prescription medications to be listed. * No history of alcohol or substance abuse issues or alcohol-related medical conditions. * No history of liver disease. * No history of significant violent behavior. * Uses alcohol socially on a regular basis. * Not naïve to consuming more than 4 drinks at one time.…
Interventions
- Dietary SupplementSupplement
Contains ingredients believed to reduce Blood Alcohol Concentration and symptoms of alcohol impairment.
- Dietary SupplementPlacebo
Placebo
Location
- The Warehouse St. PeteSt. Petersburg, Florida