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

NCT07669766 | Completed

• 1 other identifier: BB2512MD-154
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change from Baseline Objective Sleep Efficiency at Day 28

  Baseline (Day 0) and Day 28

• Change from Baseline Objective Total Sleep Time at Day 28

  Baseline (Day 0) and Day 28

• Change from Baseline Objective Sleep Latency at Day 28

  Baseline (Day 0) and Day 28

• Change from Baseline Objective REM Sleep Duration at Day 28

  Baseline (Day 0) and Day 28

• Change from Baseline Objective Deep Sleep Duration at Day 28

  Baseline (Day 0) and Day 28

Other Outcomes (3)

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

  Baseline (Day 0) and Day 28

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

  Baseline (Day 0) and Day 28

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

  Baseline (Day 0) to Day 28

Study Arms (3)

Somato®

EXPERIMENTAL

Somato® Phytomelatonin 2mg

Dietary Supplement: Plant-based melatonin

Synthetic Melatonin

ACTIVE COMPARATOR

Synthetic Melatonin - 10mg

Dietary Supplement: Melatonin

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

Plant-based melatonin DIETARY_SUPPLEMENT

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

Also known as: Somato®, Phytomelatonin

Somato®

Melatonin DIETARY_SUPPLEMENT

10mg Synthetic Melatonin capsule

Also known as: Synthetic melatonin

Synthetic Melatonin

Placebo DIETARY_SUPPLEMENT

Placebo capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nutraland USA, Inc.: lead
• Reputable Health: collaborator

Study Sites (1)

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

Wilmington, Delaware, 19808, United States

Location

MeSH Terms

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: June 25, 2026
• Study Start: January 13, 2026
• Primary Completion: April 17, 2026
• Study Completion: April 17, 2026
• Last Updated: June 30, 2026

Record last verified: 2026-06

Locations

US (1)