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COMPLETED
NCT07781332
NA

A Trial to Examine the Efficacy of a Supplement Gummy to Improve Sleep Quality and Quantity

Sponsor: DTBE, LLC dba FlavCity

View on ClinicalTrials.gov

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

DIETARY_SUPPLEMENT

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