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

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

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.

Study Overview

• Status: Completed
• Conditions: Sleep
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Plant-based melatonin; Dietary supplement: Melatonin

• Study Type: Interventional
• Enrollment (Actual): 244
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Wilmington, Delaware, United States, 19808
      • N/A Decentralized Trial - address for CRO headquarters, not the study location

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; Placebo capsule
Active Comparator: Synthetic Melatonin; Synthetic Melatonin - 10mg	Dietary supplement: Melatonin; 10mg Synthetic Melatonin capsule; Other Names: Synthetic melatonin
Experimental: Somato®; Somato® Phytomelatonin 2mg	Dietary supplement: Plant-based melatonin; 2mg Phytomelatonin (plant-based melatonin from tomatoes) capsule; Other Names: Somato®; Phytomelatonin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Pittsburgh Sleep Quality Index (PSQI) Global Score at 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.	Baseline (Day 0) and Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Objective Sleep Efficiency at 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.	Baseline (Day 0) and Day 28
Change from Baseline Objective Total Sleep Time at Day 28	Total accumulated sleep duration in minutes per night, measured continuously via the Oura Ring 3.0 wearable device.	Baseline (Day 0) and Day 28
Change from Baseline Objective Sleep Latency at Day 28	The time taken to transition from full wakefulness to sleep in minutes, measured continuously via the Oura Ring 3.0 wearable device.	Baseline (Day 0) and Day 28
Change from Baseline Objective REM Sleep Duration at Day 28	Total duration of Rapid Eye Movement (REM) sleep in minutes per night, measured continuously via the Oura Ring 3.0 wearable device.	Baseline (Day 0) and Day 28
Change from Baseline Objective Deep Sleep Duration at Day 28	Total duration of Deep (slow-wave) sleep in minutes per night, measured continuously via the Oura Ring 3.0 wearable device.	Baseline (Day 0) and Day 28
Change from Baseline Objective Light Sleep Duration at Day 28	Total duration of Light sleep in minutes per night, measured continuously via the Oura Ring 3.0 wearable device.	Baseline (Day 0) and Day 28
Change from Baseline Nocturnal Resting Heart Rate at Day 28	Average overnight resting heart rate in beats per minute (bpm), measured continuously via the Oura Ring 3.0 wearable device.	Baseline (Day 0) and Day 28
Change from Baseline Nocturnal Heart Rate Variability (HRV) at 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.	Baseline (Day 0) and Day 28

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline 36-Item Short-Form Health Survey (SF-36) Score at 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.	Baseline (Day 0) and Day 28
Change from Baseline Morning Functioning Visual Analogue Scale (VAS) Composite Score at 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.	Baseline (Day 0) and Day 28
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Sub-component Scores at 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.	Baseline (Day 0) to Day 28

Collaborators and Investigators

• Sponsor: Nutraland USA, Inc.
• Collaborators: Reputable Health

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2026
• Primary Completion (Actual): April 17, 2026
• Study Completion (Actual): April 17, 2026

Study Registration Dates

• First Submitted: February 3, 2026
• First Submitted That Met QC Criteria: June 22, 2026
• First Posted (Actual): June 25, 2026

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles; Tryptamines; Melatonin
• Other Study ID Numbers: BB2512MD-154

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No