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OpenTrials
Completed

NCT Number: NCT06215573

Effect of a Novel Melatonin Supplement on Sleep Quality

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.

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Key information

Conditions

Sleep Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sport & Health Sciences University of Exeter

Exeter, Devon, EX1 2LU, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

melatonin

Dietary Supplement

5mg melatonin supplement, once daily, from Ritual BioSeries

Placebo supplement

Dietary Supplement

Placebo supplement, once daily, from Ritual BioSeries

Primary outcomes

  1. Pharmacokinetic

    Time frame: 10 hours

    Serum melatonin concentration area under curve

  2. Sleep efficiency

    Time frame: 2 weeks

    Sleep efficiency, as total time asleep as percentage of time in bed

Secondary outcomes

  1. Sleep diary

    Time frame: 2 weeks

    Sleep diary recorded daily via 'consensus sleep diary - core'

  2. Recovery and well being

    Time frame: 2 weeks

    Recovery and well being recorded via recovery stress questionnaire (REST-Q)

  3. Sleep quality

    Time frame: 2 weeks

    Sleep quality determined via 'Pittsburgh Sleep Quality Index survey'

Sponsors and collaborators

Lead sponsor

University of Exeter

Other

Collaborators

  • Ritual Inc.

Registry information

Acronym: I-MASQ

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 22, 2024
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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