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OpenTrials
Completed

NCT Number: NCT07781332

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.

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Las Vegas, Nevada, 89101, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Sleep Quality Score (SQS

    Time frame: Baseline, Day 1, and Day 7

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

  2. Change in Fitbit Sleep Score

    Time frame: Baseline, Day 1, and Day 7

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

  3. Change in Sleep Onset Latency

    Time frame: Baseline, Day 1, and Day 7

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

  4. Change in Quantity of Deep Sleep

    Time frame: Baseline, Day 1, and Day 7

    Assessed via Fitbit Inspire 3 sleep tracker data

  5. Change in Quantity of REM Sleep

    Time frame: Baseline, Day 1, and Day 7

    Assessed via Fitbit Inspire 3 sleep tracker data

  6. Change in Sleep Quantity

    Time frame: Baseline, Day 1, and Day 7

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

  7. Change in Frequency of Waking Up in the Night

    Time frame: Baseline, Day 1, and Day 7

    Assessed via Fitbit Inspire 3 sleep tracker data

  8. Change in Heart Rate Variability (HRV)

    Time frame: Baseline, Day 1, and Day 7

    Assessed via Fitbit Inspire 3 sleep tracker data

Secondary outcomes

  1. Perceived Effectiveness of Product at Improving Sleep

    Time frame: Day 1 and Day 7

    Assessed via self-reported product perception questionnaire

  2. Perceived Effectiveness of Product at Improving Energy Levels

    Time frame: Day 1 and Day 7

    Assessed via self-reported product perception questionnaire

  3. Perceived Effects of Product Compared to Previous Sleep Products

    Time frame: Day 1 and Day 7

    Assessed via self-reported product perception questionnaire

  4. Enjoyment of the Product

    Time frame: Day 1 and Day 7

    Assessed via self-reported product perception questionnaire

Sponsors and collaborators

Lead sponsor

DTBE, LLC dba FlavCity

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 24, 2026
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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