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

Part of paid clinical trials in Wilmington, Delaware.

Sponsor
Nutraland USA, Inc.
Study ID
NCT07669766
Status
Completed

Conditions

  • Sleep

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Plant-based melatonin — DIETARY_SUPPLEMENT
    2mg Phytomelatonin (plant-based melatonin from tomatoes) capsule
  • Melatonin — DIETARY_SUPPLEMENT
    10mg Synthetic Melatonin capsule
  • Placebo — DIETARY_SUPPLEMENT
    Placebo capsule

Study Details

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.

Key Dates

Start date
Jan 13, 2026
Status verified
Jun 2026
Primary completion
Apr 17, 2026
Completion
Apr 17, 2026

Study Design

Enrollment
244 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Somato®
    Somato® Phytomelatonin 2mg
  • Active Comparator: Synthetic Melatonin
    Synthetic Melatonin - 10mg
  • Placebo Comparator: Placebo
    Placebo

Primary Outcome Measure

Change from Baseline Pittsburgh Sleep Quality Index (PSQI) Global Score at Day 28 [ Time Frame: Baseline (Day 0) and Day 28 ]

Locations (1)

FacilityCityStateZIPSite coordinators
N/A Decentralized Trial - address for CRO headquarters, not the study locationWilmingtonDelaware19808-

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

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