A randomized, double-blind, placebo-controlled direct-to-consumer study assessing the impact of health and wellness products on fatigue and related health outcomes
This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States. Eligible participants will (1) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, and (2) express acceptance in taking a product and not knowing its formulation until the end of the study. Participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded. Self-reported data are collected electronically from eligible participants for 7 weeks. Participant reports of health indicators will be collected at baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
1,000
Participants will use their Energy Placebo Control as directed for a period of 6 weeks.
Participants will use their Energy Active Product 1 as directed for a period of 6 weeks.
Participants will use their Energy Active Product 2 as directed for a period of 6 weeks.
Radicle Science, Inc
Del Mar, California, United States
Change in fatigue
Difference between rates of change over time in Fatigue score as assessed by the PROMIS Fatigue 8a (scale 8-40; where the higher scores correspond to worse fatigue)
Time frame: 7 weeks
Change in cognitive function
Difference between rates of change over time in Cognitive Function score as assessed by the PROMIS Cognitive Function 4a (scale 4-20; where the higher scores correspond to better cognitive function)
Time frame: 7 weeks
Change in sleep disturbance
Difference between rates of change over time in Sleep disturbance score as assessed by the PROMIS Sleep Disturbance 4a (scale 4-20; where the higher scores correspond to worse sleep)
Time frame: 7 weeks
Change in mood
Difference between rates of change over time in Mood score as assessed by the PROMIS Depression 4a (scale 4-20; where the higher scores correspond to worse mood)
Time frame: 7 weeks
Minimal clinical importance difference (MCID) in fatigue
Likelihood of achieving a MCID in fatigue, as measured by PROMIS Fatigue 8a (scale 8-40; where the higher scores correspond to worse fatigue)
Time frame: 7 weeks
Minimal clinical importance difference (MCID) in cognitive function
Likelihood of achieving a MCID in cognitive function, as measured by PROMIS Cognitive Function 4a (scale 4-20; where the higher scores correspond to better cognitive function)
Time frame: 7 weeks
Minimal clinical importance difference (MCID) in sleep disturbance
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Participants will use their Energy Active Product 3 as directed for a period of 6 weeks.
Likelihood of achieving a MCID in sleep disturbance, as measured by PROMIS Sleep Disturbance 4a (scale 4-20; where the higher scores correspond to worse sleep)
Time frame: 7 weeks
Minimal clinical importance difference (MCID) in mood
Likelihood of achieving a MCID in mood, as measured by PROMIS Depression 4a (scale 4-20; where the higher scores correspond to worse mood)
Time frame: 7 weeks