Abstract

Andrzej Chruscinski* and Eric Hoskins

ABSTRACT

A novel dietary supplement was developed to help accelerate alcohol metabolism, enhance cognition, reduce hangover symptoms, and provide nutritional support in intoxicated individuals. Here, we report the results from a clinical trial using FSD-F2R6 on blood alcohol concentration (BAC) and measures of impairment in healthy participants in a state of acute alcohol intoxication. A randomized double-blind placebo-controlled crossover clinical trial was conducted with healthy participants (n=26). Each participant consumed a calibrated amount of alcohol (1 g/kg) in each session, achieving a peak BAC in the range of 0.07-0.11%. Participants consumed either a single dose of FSD-F2R6 or placebo. BAC and various visual analog scales, hemodynamic parameters, cognitive tests, and hangover assessments were conducted post-treatment. Compared with placebo, FSD-F2R6 significantly reduced BAC levels post-treatment. Additionally, 70.8% (17/24) of rapidly responding participants had an average 40% greater BAC decrease with FSD-F2R6 at 30 min than with placebo. FSD-F2R6 also attenuated alcohol-induced increases in heart rate and decreases in blood pressure. Treatment with FSD-F2R6 significantly improved cognition, mental clarity, energy, alertness and clear-headedness, and the symptoms of alcohol intoxication, as early as 30 min post-treatment. FSD-F2R6 significantly reduced hangover symptoms, with a three-fold reduction in headache at 4 hours and a four-fold reduction in headache at 8 hours. There were no serious adverse events. FSD-F2R6 is a safe and effective dietary supplement to mitigate the immediate effects of excess alcohol consumption efficiently by reducing BAC, improving cognition, reducing the signs and symptoms of alcohol intoxication, and reducing hangover effects.