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OpenTrials
Completed

NCT Number: NCT07669766

Somato® (Phytomelatonin) Versus Synthetic Melatonin and Placebo on Sleep Quality

This study examines the effects of a plant-based phytomelatonin supplement compared to synthetic melatonin and placebo in adults with suboptimal sleep quality. The research uses a randomized, double-blind, placebo-controlled, three-arm clinical trial design. The primary aim is to determine whether phytomelatonin improves sleep outcomes compared to placebo and whether it matches or exceeds synthetic melatonin. Participants will be randomly assigned to receive 2 mg phytomelatonin, 10 mg synthetic melatonin, or an inactive placebo. Each participant will take one capsule nightly for 28 days. Objective sleep metrics will be captured continuously using the Oura Ring wearable device. Subjective outcomes will be measured at baseline and post-intervention using validated surveys such as the Pittsburgh Sleep Quality Index and the SF-36. Weekly visual analog scales will assess morning grogginess. Safety, tolerability, and user experience differences between groups will also be evaluated.

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Key information

Conditions

Sleep

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

N/A Decentralized Trial - address for CRO headquarters, not the study location

Wilmington, Delaware, 19808, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Device Compliance: Willingness to consistently wear an Oura Ring Gen3 and maintain an active membership throughout the study duration.
  • Baseline Sleep Score: A baseline Oura sleep score of less than 75, indicating sub-optimal sleep quality.
  • Oura Ring Usage History: Demonstrated at least 80% adherence to Oura Ring use during the 30 days prior to enrollment.
  • Health and Supplement Stability: No significant changes in dietary supplement use or medical history within the past 30 days, to ensure stability in baseline physiological and health conditions.

Exclusion criteria

  • Current or recent use (within the past 30 days) of any sleep-promoting dietary supplement.
  • Current or recent use (within the past 30 days) of any sleep-promoting medications, whether prescription or over-the-counter.
  • Pregnant or breastfeeding women will be excluded from the study.
  • Substance Use Disorder: Individuals with a history of drug or alcohol dependency who have not maintained sobriety for a minimum of the past 12 months.
  • Severe Medical Conditions: Presence of severe or unstable medical conditions that may interfere with study participation or outcomes.
  • Use of Mood-Affecting Medications: Use of any medications known to significantly influence mood, circadian rhythms, or melatonin pathways.
  • Sensitivity to Nightshades: Known sensitivity or allergy to nightshade plants, including tomatoes, due to the nature of the study intervention.

Treatment and study plan

Plant-based melatonin

Dietary Supplement

2mg Phytomelatonin (plant-based melatonin from tomatoes) capsule

Other names: Somato®, Phytomelatonin

melatonin

Dietary Supplement

10mg Synthetic Melatonin capsule

Other names: Synthetic melatonin

Placebo

Dietary Supplement

Placebo capsule

Primary outcomes

  1. Change from Baseline Pittsburgh Sleep Quality Index (PSQI) Global Score at Day 28

    Time frame: Baseline (Day 0) and Day 28

    The PSQI is a self-administered questionnaire used to measure sleep quality and disturbances over a 1-month time interval. The questionnaire consists of 19 individual items, creating 7 component scores that are summed to yield one global score. The total score ranges from 0 to 21, where lower scores denote better sleep quality.

Secondary outcomes

  1. Change from Baseline Objective Sleep Efficiency at Day 28

    Time frame: Baseline (Day 0) and Day 28

    Sleep efficiency percentage as measured continuously via the Oura Ring 3.0 wearable device. Calculated as the percentage of time in bed spent asleep.

  2. Change from Baseline Objective Total Sleep Time at Day 28

    Time frame: Baseline (Day 0) and Day 28

    Total accumulated sleep duration in minutes per night, measured continuously via the Oura Ring 3.0 wearable device.

  3. Change from Baseline Objective Sleep Latency at Day 28

    Time frame: Baseline (Day 0) and Day 28

    The time taken to transition from full wakefulness to sleep in minutes, measured continuously via the Oura Ring 3.0 wearable device.

  4. Change from Baseline Objective REM Sleep Duration at Day 28

    Time frame: Baseline (Day 0) and Day 28

    Total duration of Rapid Eye Movement (REM) sleep in minutes per night, measured continuously via the Oura Ring 3.0 wearable device.

  5. Change from Baseline Objective Deep Sleep Duration at Day 28

    Time frame: Baseline (Day 0) and Day 28

    Total duration of Deep (slow-wave) sleep in minutes per night, measured continuously via the Oura Ring 3.0 wearable device.

  6. Change from Baseline Objective Light Sleep Duration at Day 28

    Time frame: Baseline (Day 0) and Day 28

    Total duration of Light sleep in minutes per night, measured continuously via the Oura Ring 3.0 wearable device.

  7. Change from Baseline Nocturnal Resting Heart Rate at Day 28

    Time frame: Baseline (Day 0) and Day 28

    Average overnight resting heart rate in beats per minute (bpm), measured continuously via the Oura Ring 3.0 wearable device.

  8. Change from Baseline Nocturnal Heart Rate Variability (HRV) at Day 28

    Time frame: Baseline (Day 0) and Day 28

    Overnight Heart Rate Variability (HRV) in milliseconds (ms) using the rMSSD (Root Mean Square of Successive Differences) method, measured continuously via the Oura Ring 3.0 wearable device.

Other outcomes

  1. Change from Baseline 36-Item Short-Form Health Survey (SF-36) Score at Day 28

    Time frame: Baseline (Day 0) and Day 28

    The SF-36 is a multi-purpose, short-form health survey. Scored from 0 to 100, where higher scores mean better health outcomes.

  2. Change from Baseline Morning Functioning Visual Analogue Scale (VAS) Composite Score at Day 28

    Time frame: Baseline (Day 0) and Day 28

    Morning functioning assessed via a 6-item questionnaire utilizing a Visual Analogue Scale. Items measure dimensions such as grogginess, sleepiness, difficulty concentrating, alertness, feeling refreshed, and readiness for the day. Individual items are directionally aligned and averaged to create a composite score ranging from 1 to 10, where higher scores represent better morning functioning.

  3. Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Sub-component Scores at Day 28

    Time frame: Baseline (Day 0) to Day 28

    The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-reported questionnaire that evaluates subjective sleep quality changes from baseline. Each component is scored on a Likert scale ranging from 0 to 3, where higher scores reflect a greater severity of sleep difficulties within that specific domain.

Sponsors and collaborators

Lead sponsor

Nutraland USA, Inc.

Industry

Collaborators

  • Reputable Health

Registry information

Official study title

Sleep Solutions in Focus: A Randomized Comparison of Phytomelatonin (Somato®), Synthetic Melatonin, and Placebo

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 25, 2026
Registry last updated
Jun 30, 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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