Effect of a Novel Melatonin Supplement on Sleep Quality (I-MASQ)

March 25, 2025 updated by: University of Exeter

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Devon
      • Exeter, Devon, United Kingdom, EX1 2LU
        • Sport & Health Sciences University of Exeter

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy
  • Aged 18-40
  • Sometimes have trouble sleeping (Pittsburgh sleep quality index score >5)

Exclusion Criteria:

  • Routinely taking melatonin supplements or other drugs known to affect sleep
  • A diagnosed sleep disorder
  • Major psychiatric illness
  • Current physical injury
  • Known or suspected hypersensitivity to melatonin
  • Presence of major sleep disruptors at home (e.g. new born baby)
  • Night shift/rotational-shift work
  • Receiving non-pharmacological treatment for sleep disorder (e.g. cognitive behavioral therapy)
  • Substance use disorder
  • Recent (<1 month) increase in daily caffeinated drink consumption
  • Consuming >14 standard alcoholic drinks per week
  • Pregnant or lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Melatonin supplementation
5mg melatonin supplement from Ritual Inc's BioSeries
Dietary supplement: Melatonin
5mg melatonin supplement, once daily, from Ritual BioSeries
Placebo Comparator: Placebo supplementation
Placebo supplement from Ritual Inc.
Dietary supplement: Placebo supplement
Placebo supplement, once daily, from Ritual BioSeries

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic
Time Frame: 10 hours
Serum melatonin concentration area under curve
10 hours
Sleep efficiency
Time Frame: 2 weeks
Sleep efficiency, as total time asleep as percentage of time in bed
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep diary
Time Frame: 2 weeks
Sleep diary recorded daily via 'consensus sleep diary - core'
2 weeks
Recovery and well being
Time Frame: 2 weeks
Recovery and well being recorded via recovery stress questionnaire (REST-Q)
2 weeks
Sleep quality
Time Frame: 2 weeks
Sleep quality determined via 'Pittsburgh Sleep Quality Index survey'
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Exeter

Collaborators

Ritual Inc.

Investigators

  • Principal Investigator: Francis B Stephens, PhD, University of Exeter

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2023

Primary Completion (Actual)

April 18, 2024

Study Completion (Actual)

April 18, 2024

Study Registration Dates

First Submitted

January 10, 2024

First Submitted That Met QC Criteria

January 10, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 30, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WT4634027_I-MASQ v2.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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