Radicle Energy VBMTM: A randomized, double-blind, placebo- controlled direct-to-consumer study assessing the impact of health and wellness products on fatigue and related health outcomes.
Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities
Assigned sex at birth will determine sex-specific recruitment and PROs (male vs female) employed, when needed
Resides in the United States
Has the opportunity for at least 30% improvement in their primary health outcome
None
Parallel
Energy Product Placebo Control
Dietary supplementParticipants will use their Energy Product Placebo Control as directed for a period of 6 weeks.
Energy Active Product 1
Dietary supplementParticipants will use their Energy Active Product 1 as directed for a period of 6 weeks.
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)
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)
Change in Global Mental Health
Change in Global Mental Health: Difference in rates of change over time in cognitive function score as assessed by PROMIS Global Mental Health 4A (scale 4-20; where lower scores correspond to worse cognitive function)
Change in sleep
Change in sleep: Difference in rates of change over time in sleep score as assessed by PROMIS Sleep Disturbance 8A (scale 8-40; where higher scores correspond to higher levels of sleep disturbance)
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)
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 Global Mental Health
Minimal clinically important difference (MCID) in Global Mental Health: Likelihood of experiencing minimal clinically important difference in cognitive function score as assessed by PROMIS Global Mental Health (scale 4-20; where lower scores correspond to worse cognitive function)
Minimal clinically important difference (MCID) in sleep
Minimal clinically important difference (MCID) in sleep: Likelihood of experiencing minimal clinically important difference in sleep score as assessed by PROMIS Sleep Disturbance 8A (scale 8-40; where higher scores correspond to higher levels of sleep disturbance)
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This trial is not recruiting at the moment. You can still explore other options:
