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A Trial to Examine the Efficacy of a Supplement Gummy to Improve Sleep Quality and Quantity
Sponsor: DTBE, LLC dba FlavCity
Summary
This single-group trial evaluates the efficacy of FlavCity's Sleep Gummy supplement on sleep health in adults aged 20-50 who self-report issues with sleep. Forty participants will take one sleep gummy nightly (30 minutes before bed) for 7 days while wearing a Fitbit Inspire 3 sleep tracker to monitor objective sleep metrics. Participants will complete study-specific questionnaires and report sleep tracker data at Baseline, Day 1 (the day after first use), and Day 7. The study is conducted entirely virtually. Primary outcomes focus on sleep quality and quantity (including time to fall asleep, deep sleep, REM sleep, and grogginess upon waking), assessed via the validated Sleep Quality Scale (SQS) and sleep tracking biomarkers. Secondary outcomes assess participant perceptions of the product.
Key Details
Gender
All
Age Range
20 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2023-09-01
Completion Date
2023-09-10
Last Updated
2026-08-24
Healthy Volunteers
No
Interventions
Sleep Gummy Intervention
All enrolled participants receive FlavCity Sleep Gummy, one gummy taken orally 30 minutes before bedtime (at least one hour after the evening meal) daily for 7 consecutive days.
Locations (1)
Citruslabs
Las Vegas, Nevada, United States