Rapid BAC Reduction with Nutraceutical Blend Study

Part of paid clinical trials in St. Petersburg, Florida.

Sponsor
Medical Life Care Planners, LLC
Study ID
NCT06722898
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Alcohol
  • Alcohol Consumption
  • Hangover Symptoms, NAC
  • Veisalgia

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Supplement — DIETARY_SUPPLEMENT
    Contains ingredients believed to reduce Blood Alcohol Concentration and symptoms of alcohol impairment.
  • Placebo — DIETARY_SUPPLEMENT
    Placebo

Study Details

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.

Key Dates

Start date
Dec 1, 2024
Status verified
Dec 2024
Primary completion
Feb 1, 2025
Completion
Feb 7, 2025

Study Design

Enrollment
35 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
  • Active Comparator: Liquid

Primary Outcome Measure

Blood Alcohol Concentration [ Time Frame: 90 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Warehouse St. PeteSt. PetersburgFlorida33712
Rachel Borch

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The Warehouse St. Pete· St. Petersburg, FL

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