Effect Of A Novel Melatonin Supplement On Sleep Quality

Not Applicable

Active, not recruiting

• Conditions: Sleep
• Interventions: Dietary Supplement: Placebo supplement; Dietary Supplement: Melatonin

• Registration Number: NCT06215573
• Lead Sponsor: University of Exeter

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-04
• Study First Submitted: 2024-01-10
• Study First Submitted QC: 2024-01-10
• Study First Posted: 2024-01-22
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-20
• Last Update Posted: 2024-02-22
• Primary Completion: 2024-09-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo supplementation	Placebo supplement	Placebo supplement from Ritual Inc.
Melatonin supplementation	Melatonin	5mg melatonin supplement from Ritual Inc's BioSeries

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic	10 hours	Serum melatonin concentration area under curve
Sleep efficiency	2 weeks	Sleep efficiency, as total time asleep as percentage of time in bed

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sport & Health Sciences University of Exeter; 🇬🇧 Exeter, Devon, United Kingdom