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COMPLETED
NCT07669766
NA

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

Sponsor: Nutraland USA, Inc.

View on ClinicalTrials.gov

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

DIETARY_SUPPLEMENT

Plant-based melatonin

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

DIETARY_SUPPLEMENT

Melatonin

10mg Synthetic Melatonin capsule

DIETARY_SUPPLEMENT

Placebo

Placebo capsule

Locations (1)

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

Wilmington, Delaware, United States