Radicle Revive™: A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on menopausal-related health issues associated health outcomes.
Adults, at least 40 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
Resides in the United States
Has the opportunity for at least 30% improvement in their primary health outcome
None
Parallel
Revive Product Placebo Control
Dietary supplementParticipants will use their Control as directed for a period of 12 weeks.
Revive Active Product 1
Dietary supplementParticipants will use their Active product as directed for a period of 12 weeks.
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 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 feelings of anxiety
Change in feelings of anxiety: Difference between rates of change over time in feelings of anxiety score as assessed by PROMIS Anxiety 8A (scale 8-40; with higher scores corresponding to more severe anxiety)
Hot Flash Interference over 12 weeks
Hot Flash interference assessed by a single self report item. Indicating hot flash interference in the previous 24 hours. Scale 1-7 with higher scores indication greater interference.
Hot Flash Frequency
Hot Flash frequency assessed by a single self-report item. Indicating hot flash frequency in the previous 24 hours. Options ranged from 0 to 6. With higher scores indicating greater frequency of hot flashes.
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 feelings of anxiety
Minimal clinically important difference (MCID) in feelings of anxiety: Likelihood of experiencing minimal clinically important difference in feelings of anxiety score as assessed by PROMIS Anxiety 8A (scale 8-40; with higher scores corresponding to more severe anxiety)
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