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.
Edge+Ease
Lead sponsor
Citruslabs
Collaborator