This is a decentralized, single-arm, open-label clinical trial evaluating the effects of the Edge+Ease PM+AM dietary supplement system on sleep quality, mood, mental clarity, focus, and digestive comfort in 35 generally healthy adults aged 18-65 years over 12 weeks of daily use.
Participants will take the Edge+Ease PM product (one serving of powder mixed in approximately 150-250 mL water) in the evening approximately 60-90 minutes before bedtime, and the Edge+Ease AM product (two capsules) in the morning with food. All study activities are conducted remotely via the Citruslabs platform. Participants will complete questionnaires at Baseline, Week 4, Week 8, and Week 12, and will wear a Fitbit continuously beginning 7 days before product use through the end of the 12-week intervention period to provide objective sleep data.
Male and female adults aged 18 to 65 years.
Self-reports difficulty falling asleep, staying asleep, or having poor sleep quality overall, in the last 4 weeks.
Self-reports seeking support in at least one of the following domains: Difficulty switching off, perceived stress load, mental overload, next-day mental fatigue, reduced mental clarity or reduced cognitive readiness.
Generally healthy.
Known allergy or hypersensitivity to any ingredient in the test product.
Currently pregnant, breastfeeding, or trying to conceive, or will be during the study period.
Currently undergoing treatment for cancer, or have had a serious illness requiring hospitalization in the last 3 months.
Diagnosed severe psychiatric disorder (e.g., bipolar disorder, schizophrenia, major depressive disorder requiring active treatment adjustment) that, in the judgment of the Investigator, would compromise participation or interpretation of results.
Single group
Edge+ease PM
Dietary supplementAll enrolled participants receive the Edge+Ease PM+AM system daily for 12 weeks. The PM product (powder) is taken as one serving mixed in approximately 150-250 mL water, around 60-90 minutes before intended bedtime, ideally after dinner.
Change in Fitbit-measured sleep quality score
Mean change in Fitbit sleep quality score from baseline, based on the average of three days per time point
Change in Fitbit-measured time asleep
Mean change in total time asleep from baseline, measured via Fitbit, based on the average of three days per time point
Change in Fitbit-measured time awake
Mean change in time awake from baseline, measured via Fitbit, based on the average of three days per time point
Change in Fitbit-measured deep sleep
Mean change in deep sleep duration from baseline, measured via Fitbit, based on the average of three days per time point
Change in self-reported mood
Mean change in self-reported mood assessed via questionnaire administered through the study platform
Change in self-reported calm
Mean change in self-reported calm assessed via questionnaire administered through the study platform
Change in self-reported evening wind-down
Mean change in self-reported evening wind-down assessed via questionnaire administered through the study platform
Change in self-reported emotional steadiness
Mean change in self-reported emotional steadiness assessed via questionnaire administered through the study platform
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Edge+Ease
Lead sponsor
Citruslabs
Collaborator
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