About this trial
Radicle Clarity CNM™: A randomized, double-blind, placebo-controlled direct-to-consumer study assessing the impact of health and wellness products on cognitive function and related health outcomes among E-Gamers.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults, aged 21 - 45 years at the time of electronic consent, inclusive of all ethnicities, races, and gender identities
Assigned sex at birth will determine sex-specific recruitment and surveys (male vs female) employed, when needed
Identifies as a young professional (working 30+ hrs/week)
May identify as an E-gamer (playing video games 5+hrs/week for the past year)
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Clarity Product Placebo Control
Dietary supplementParticipants will use their Clarity Product Placebo Control as directed for a period of 8 weeks
Clarity Active Product
Dietary supplementParticipants will use their Clarity Active Product as directed for a period of 8 weeks
Treatment groups
Trial outcomes
Primary outcomes
Change in cognitive function
Change in cognitive function: Difference in rates of change over time in cognitive function score as assessed by PROMIS Cognitive Function 8A (scale 8-40; where lower scores correspond to worse cognitive function)
Secondary outcomes
Change in cognitive abilities
Change in cognitive abilities: Difference between rates of change over time in Cognitive Abilities score as assessed by PROMIS Cognitive Function - Abilities 8a (scale 8-40; where the higher scores correspond to better cognitive abilities)
Change in fatigue
Change in fatigue: Difference in rates of change over time in fatigue score as assessed by Patient Reported Outcome Measurement System (PROMIS) Fatigue 8A (scale 8-40; where higher scores correspond to more severe fatigue)
Other outcomes
Minimal clinically important difference (MCID) in cognitive function
Minimal clinically important difference (MCID) in cognitive function: Likelihood of experiencing minimal clinically important difference in cognitive function score as assessed by PROMIS Cognitive Function 8A (scale 8-40; where lower scores correspond to worse cognitive function)
Minimal clinically important difference (MCID) in cognitive abilities
Minimal clinically important difference (MCID) in cognitive abilities: Likelihood of experiencing minimal clinically important difference in cognitive abilities score as assessed by PROMIS Cognitive Function - Abilities 8a (scale 8-40; where the higher scores correspond to better cognitive abilities)
Minimal clinically important difference (MCID) in fatigue
Minimal clinically important difference (MCID) in fatigue: Likelihood of experiencing minimal clinically important difference in fatigue score as assessed by PROMIS Fatigue 8A (scale 8-40; where higher scores correspond to more severe fatigue)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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