Effect of a Novel Melatonin Supplement on Sleep Quality

NCT06215573 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-03-30

No results posted yet for this study

Summary

Melatonin is a hormone naturally found in our body that increases in our blood at night and controls how we sleep. Melatonin can also be taken as a pill and numerous clinical trials have documented improved sleep quality following melatonin supplementation before bed. However, it is not known whether such supplements actually increase blood melatonin above normal levels, particularly at night.

The aims of this study are to investigate whether a novel melatonin supplement (Ritual Sleep BioSeriesTM Melatonin) can increase blood melatonin in human participants at night, and to determine if taking the supplement before bed for two-weeks can improve sleep quality.

Conditions

  • Sleep

Interventions

DIETARY_SUPPLEMENT

Melatonin

5mg melatonin supplement, once daily, from Ritual BioSeries

DIETARY_SUPPLEMENT

Placebo supplement

Placebo supplement, once daily, from Ritual BioSeries

Sponsors & Collaborators

  • Ritual Inc.

    collaborator UNKNOWN
  • University of Exeter

    lead OTHER

Principal Investigators

  • Francis B Stephens, PhD · University of Exeter

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2023-12-04
Primary Completion
2024-04-18
Completion
2024-04-18

Countries

  • United Kingdom

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 NCT06215573 on ClinicalTrials.gov