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

NCT07669766 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 244

Last updated 2026-06-30

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Melatonin

10mg Synthetic Melatonin capsule

DIETARY_SUPPLEMENT

Placebo

Placebo capsule

DIETARY_SUPPLEMENT

Plant-based melatonin

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

Sponsors & Collaborators

  • Reputable Health

    collaborator OTHER

  • Nutraland USA, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-13
Primary Completion
2026-04-17
Completion
2026-04-17

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07669766 on ClinicalTrials.gov