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Somato® (Phytomelatonin) Versus Synthetic Melatonin and Placebo on Sleep Quality
Sponsor: Nutraland USA, Inc.
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.
Official title: Sleep Solutions in Focus: A Randomized Comparison of Phytomelatonin (Somato®), Synthetic Melatonin, and Placebo
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
244
Start Date
2026-01-13
Completion Date
2026-04-17
Last Updated
2026-06-25
Healthy Volunteers
Yes
Conditions
Interventions
Plant-based melatonin
2mg Phytomelatonin (plant-based melatonin from tomatoes) capsule
Melatonin
10mg Synthetic Melatonin capsule
Placebo
Placebo capsule
Locations (1)
N/A Decentralized Trial - address for CRO headquarters, not the study location
Wilmington, Delaware, United States