This is a parallel group, randomized, double-blind, placebo-controlled clinical study assessing the safety and effects of a novel nutritional product on self-reported cognitive function and health in adults that reside in the USA. Participants will take their assigned study product (active or placebo) for 8 weeks and answer validated electronic surveys assessing cognitive function delivered to them through a text message (SMS) link or through email.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
650
Novel Nutritional Product targeting Cognition
Identical placebo product
Radicle Science, Inc Office
Encinitas, California, United States
Cognitive function
Change in cognitive function score as assessed by PROMIS Cognitive Function 8A (scale 8-40; where higher scores correspond to better cognitive function)
Time frame: 8 weeks
Fatigue
Change in fatigue score as assessed by Patient Reported Outcome Measurement System (PROMIS) Fatigue 4A (scale 4-20; where higher scores correspond to worse fatigue)
Time frame: 8 weeks
Sleep-related impairment
Change in sleep score as assessed by PROMIS Sleep-Related Impairment 4a (scale 4-20; where the higher scores correspond to worse sleep)
Time frame: 8 weeks
Cognitive abilities
Change in Cognitive Abilities score as assessed by PROMIS Cognitive Function - Abilities 8a (scale 8-40; where the higher scores correspond to better cognitive abilities)
Time frame: 8 weeks
Cognitive function (brain health) via smartphone application assessments
Change in cognitive function evaluated with DANA Brain Vital app
Time frame: 8 weeks
Minimal clinically important difference (MCID) in cognitive function
Likelihood of achieving minimal clinically important difference in cognitive function score as assessed by PROMIS Cognitive Function 8A (scale 8-40; where higher scores correspond to better cognitive function)
Time frame: 8 weeks
Minimal clinically important difference (MCID) in fatigue
Likelihood of achieving minimal clinically important difference in fatigue score as assessed by PROMIS Fatigue 4A (scale 4-20; where higher scores correspond to worse fatigue)
Time frame: 8 weeks
Minimal clinically important difference (MCID) in sleep
Likelihood of achieving minimal clinically important difference in sleep score, as measured by PROMIS Sleep-Related Impairment 4a (scale 4-20; where the higher scores correspond to worse sleep)
Time frame: 8 weeks
Minimal clinically important difference (MCID) in cognitive abilities
Likelihood of achieving 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)
Time frame: 8 weeks
Adverse Events
Time frame: 8 weeks
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