This will be a (2 visit) double-blind, randomized, placebo crossover design clinical study to assess the potential benefits of FSD-F2R6-A-CP versus a placebo by assessing its impact on side effect profiles as well as cognitive abilities, motor abilities, and breath alcohol concentration following ingestion of alcohol followed by the dietary supplement or placebo. This study will enroll healthy men and women.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
26
FSD-F2R6-A-CP is a unique dietary supplement with natural ingredients, vitamins and minerals that potentially enhances cognition, replenishes cofactors needed for alcohol metabolism and may accelerate alcohol metabolism in the body.
Placebo drink designed to match FSD-F2R6-A-CP in color and taste.
Applied Science and Performance Institute
Tampa, Florida, United States
Intoxication
Intoxication will be measured using a 0-100 mm VAS scale, with left (0 mm) and right (100 mm) anchors designated 'not at all' and 'very much' to assess subjects' subjective experience of intoxication.
Time frame: Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment
Impairment
Impairment will be measured using a 0-100 mm VAS scale, with left (0 mm) and right (100 mm) anchors designated 'not at all' and 'very much' to assess subjects' subjective experience of impairment.
Time frame: Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment
Mental Fatigue
Mental fatigue will be measured using a 0-100 mm VAS scale, with left (0 mm) and right (100 mm) anchors designated 'not at all' and 'very much' to assess subjects' subjective experience of mental fatigue.
Time frame: Change in pre-treatment score to 0.5, 1, 2 and4 hours post-treatment
Clearheaded-Muzzy
Clearheaded-Muzzy will be measured by a 100 mm visual analog scale (VAS) representing bipolar adjective pairs for the assessment of both alerting and sedating CNS drug effects.
Time frame: Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment
Clumsy-Well Coordinated
Clumsy-Well Coordinated will be measured by a 100 mm visual analog scale (VAS) representing bipolar adjective pairs for the assessment of both alerting and sedating CNS drug effects.
Time frame: Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment
Energetic-Lethargic
Energetic-Lethargic will be measured by a 100 mm visual analog scale (VAS) representing bipolar adjective pairs for the assessment of both alerting and sedating CNS drug effects.
Time frame: Change in pre-treatment score to 0.5, 1, 2 an 4 hours post-treatment
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Drowsy-Alert
Drowsy-Alert will be measured by a 100 mm visual analog scale (VAS) representing bipolar adjective pairs for the assessment of both alerting and sedating CNS drug effects.
Time frame: Change in pre-treatment score to 0.5, 1, 2 an 4 hours post-treatment
Mentally Slow-Quick Witted
Mentally Slow-Quick Witted will be measured by a 100 mm visual analog scale (VAS) representing bipolar adjective pairs for the assessment of both alerting and sedating CNS drug effects.
Time frame: Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment
Headache
Headache will be measured on a 100 mm VAS. The subject will indicate the severity of any headache by drawing a vertical line on the horizontally positioned VAS. The left end (0 mm) of the VAS will designate 'no pain' and the right end (100mm) will designate 'most severe pain imaginable' with no intermediate divisions or descriptive terms.
Time frame: Change in pre-treatment score to 0.5, 1, 2, 4 and 8 hours post-treatment
Druid App Test
This is a peer-reviewed, phone app with 4 different tests that test for cognitive and motor impairments.
Time frame: Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment
Digital Symbol Substitution Task (DSST)
This is a computerized test that will be used to assess the subject's cognitive functioning. This will test processing speed, working memory, visuospatial processing and attention.
Time frame: Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment
Trail Making Test (TMT)
This is a neuropsychological test of visual attention and task switching. Subjects will connect a set of 25 dots in order as quickly and accurately as possible. This will provide visual search speed, scanning, speed of processing, mental flexibility, and executive functioning. This test will be completed on a computer.
Time frame: Change in pre-treatment score to 0.5, 1, 2 and 4 hours post-treatment
Breath Alcohol Concentration
To quantify the participants' level of intoxication through objective measures, breath alcohol concentrations will be measured with a breathalyzer.
Time frame: Change in pre-treatment score to 0.5, 1, 1.5, 2, 3 and 4 hours post-treatment
Acute Hangover Severity Scale (AHSS)
This is a 12-item questionnaire that rates the severity of a hangover from 0 to 120 with higher scores indicating worse hangover symptoms.
Time frame: Measured at 8 and 24 hours after treatment
Single Item Hangover Severity Score
This is a single item outcome measure that rates the severity of a hangover from 0 to 10 with higher scores indicating worse hangover symptoms.
Time frame: Measured at 8 and 24 hours after treatment
Systolic blood pressure
Systolic blood pressure measured in mmHg.
Time frame: Measured at baseline (before alcohol), pre-treatment and 0.5, 1, 2 and 4 hours post-treatment
Diastolic blood pressure
Diastolic blood pressure measured in mmHg
Time frame: Measured at baseline (before alcohol), pre-treatment and 0.5, 1, 2 and 4 hours post-treatment
Heart rate
Heart rate measured in beats per minute
Time frame: Measured at baseline (before alcohol), pre-treatment and 0.5, 1, 2 and 4 hours post-treatment
Respiratory rate
Respiratory rate measured in respirations per minute
Time frame: Measured at baseline (before alcohol), pre-treatment and 0.5, 1, 2 and 4 hours post-treatment
Temperature
Temperature measured in degrees fahrenheit with an infrared thermometer
Time frame: Measured at baseline (before alcohol), pre-treatment and 0.5, 1, 2 and 4 hours post-treatment