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.

NCT Number	NCT07669766
Lead Sponsor	Nutraland USA, Inc. Collaborators: Reputable Health
Conditions	Sleep
Enrollment	244 participants
Start Date	2026-01-13
Primary Completion	2026-04-17 (estimated)
Study Completion	2026-04-17 (estimated)
Updated on ClinicalTrials.gov	2026-06-30