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

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

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.

Inclusion Criteria:

• Male or female
• 20-50 years old
• Self-reported issues with sleep
• Willing to discontinue any over-the-counter medications, prescription medications, and herbal supplements used to assist with sleep
• Willing to maintain their standard sleep pattern and activity level for the duration of the study
• Be generally healthy and not living with any uncontrolled chronic disease

Exclusion Criteria:

• Diagnosed with any chronic sleep condition including insomnia, narcolepsy, or sleep apnea
• Vegan participants (as this product contains beeswax which is not suitable for participants on a vegan diet)
• Women who are pregnant, breastfeeding, or trying to conceive (TTC)
• Anyone unwilling or unable to follow the study protocol
• Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
• Has undergone in the last three weeks, is currently undergoing, or planning to undergo any significant medical procedures in the next three weeks
• A history of severe allergic reactions including but not limited to any of the product's ingredients
• Anyone who is a heavy drinker (a woman who drinks 8 or more alcoholic drinks per week or a man who drinks 15 or more alcoholic drinks per week)
• Individuals taking prescription or over-the-counter medication that affects sleep
• Use of any herbal remedies which can affect sleep
• Has a job that disrupts nighttime sleep (e.g., third shift or night shift work)
• Anyone who is using illicit drugs