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

NCT07781332 | Completed

• 1 other identifier: 20373
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep Disturbance; Poor Sleep Quality; Insomnia (Self-reported, Non-diagnosed)

Outcome Measures

Primary Outcomes (8)

• Change in Sleep Quality Score (SQS

  Change from baseline in sleep quality score as assessed using the validated Sleep Quality Scale (SQS) self-reported questionnaire.

  Baseline, Day 1, and Day 7

• Change in Fitbit Sleep Score

  Change from baseline in sleep score measured using the Fitbit Inspire 3 sleep tracker.

  Baseline, Day 1, and Day 7

• Change in Sleep Onset Latency

  Change from baseline in sleep onset latency, measured using the Fitbit Inspire 3 sleep tracker and reported in minutes.

  Baseline, Day 1, and Day 7

• Change in Quantity of Deep Sleep

  Assessed via Fitbit Inspire 3 sleep tracker data

  Baseline, Day 1, and Day 7

• Change in Quantity of REM Sleep

  Assessed via Fitbit Inspire 3 sleep tracker data

  Baseline, Day 1, and Day 7

• Change in Sleep Quantity

  Assessed via Fitbit Inspire 3 sleep tracker data and self-reported questionnaire using the Sleep Quality Scale (SQS)

  Baseline, Day 1, and Day 7

• Change in Frequency of Waking Up in the Night

  Assessed via Fitbit Inspire 3 sleep tracker data

  Baseline, Day 1, and Day 7

• Change in Heart Rate Variability (HRV)

  Assessed via Fitbit Inspire 3 sleep tracker data

  Baseline, Day 1, and Day 7

Secondary Outcomes (4)

• Perceived Effectiveness of Product at Improving Sleep

  Day 1 and Day 7

• Perceived Effectiveness of Product at Improving Energy Levels

  Day 1 and Day 7

• Perceived Effects of Product Compared to Previous Sleep Products

  Day 1 and Day 7

• Enjoyment of the Product

  Day 1 and Day 7

Study Arms (1)

Sleep Gummy Intervention

EXPERIMENTAL

Dietary Supplement: Sleep Gummy Intervention

Interventions

Sleep Gummy Intervention DIETARY_SUPPLEMENT

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.

Sleep Gummy Intervention

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• DTBE, LLC dba FlavCity: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Las Vegas, Nevada, 89101, United States

Location

MeSH Terms

Conditions

Parasomnias; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 24, 2026
• Study Start: September 1, 2023
• Primary Completion: September 10, 2023
• Study Completion: September 10, 2023
• Last Updated: August 24, 2026

Record last verified: 2026-08

Locations

US (1)