Radicle Women's HealthTM: A randomized, double-blind, placebo- controlled direct-to-consumer study assessing the impact of health and wellness products on fatigue and related health outcomes among women experiencing menopausal symptoms.
Adults, 35-60 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities
Assigned sex at birth is female
Experience at least two menopausal symptoms
Resides in the United States
None
Parallel
Fatigue Product Placebo Control
Dietary supplementParticipants will use their Fatigue Product Placebo Control as directed for a period of 6 weeks.
Fatigue Active Product 1
Dietary supplementParticipants will use their Fatigue Active Product 1 as directed for a period of 6 weeks.
Chang 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 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)
Change in menopausal quality of life
Change in menopausal quality of life: Difference between rates of change over time in menopausal quality of life score as assessed by Menopause-specific Quality of Life Questionnaire (scale 1-8; where the higher scores correspond to worse menopausal quality of life)
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 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)
Minimal clinically important difference (MCID) in menopausal quality of life
Minimal clinically important difference (MCID) in menopausal quality of life: Likelihood of experiencing minimal clinically important difference in menopausal quality of life score as assessed by Menopause-specific Quality of Life Questionnaire (scale 1-8; where the higher scores correspond to worse menopausal quality of life)
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