Effect of a Novel Melatonin Supplement on Sleep Quality

NCT06215573 | Completed

• 1 other identifier: WT4634027_I-MASQ v2.0
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

melatonin; pharmacokinetics; sleep quality

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetic

  Serum melatonin concentration area under curve

  10 hours

• Sleep efficiency

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

  2 weeks

Secondary Outcomes (3)

• Sleep diary

  2 weeks

• Recovery and well being

  2 weeks

• Sleep quality

  2 weeks

Study Arms (2)

Melatonin supplementation

EXPERIMENTAL

5mg melatonin supplement from Ritual Inc's BioSeries

Dietary Supplement: Melatonin

Placebo supplementation

PLACEBO COMPARATOR

Placebo supplement from Ritual Inc.

Dietary Supplement: Placebo supplement

Interventions

Melatonin DIETARY_SUPPLEMENT

5mg melatonin supplement, once daily, from Ritual BioSeries

Melatonin supplementation

Placebo supplement DIETARY_SUPPLEMENT

Placebo supplement, once daily, from Ritual BioSeries

Placebo supplementation

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Exeter: lead
• Ritual Inc.: collaborator

Study Sites (1)

Sport & Health Sciences University of Exeter

Exeter, Devon, EX1 2LU, United Kingdom

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Francis B Stephens, PhD

  University of Exeter

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Coded, known only to manufacturer / collaborator
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised cross over trial counterbalanced for trial order

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 22, 2024
• Study Start: December 4, 2023
• Primary Completion: April 18, 2024
• Study Completion: April 18, 2024
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)