Effect Of A Novel Melatonin Supplement On Sleep Quality

Sleep Clinical Trial

— I-MASQ  

Official title:

Effect Of A Novel Melatonin Supplement On Sleep Quality

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06215573
• Other study ID #: WT4634027_I-MASQ v2.0
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 4, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: February 2024
• Source: University of Exeter
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: December 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep

Intervention

Dietary Supplement:
• Melatonin
5mg melatonin supplement, once daily, from Ritual BioSeries
• Placebo supplement
Placebo supplement, once daily, from Ritual BioSeries

Locations

Country	Name	City	State
United Kingdom	Sport & Health Sciences University of Exeter	Exeter	Devon

Sponsors (2)

Lead Sponsor	Collaborator
University of Exeter	Ritual Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic	Serum melatonin concentration area under curve	10 hours
Primary	Sleep efficiency	Sleep efficiency, as total time asleep as percentage of time in bed	2 weeks
Secondary	Sleep diary	Sleep diary recorded daily via 'consensus sleep diary - core'	2 weeks
Secondary	Recovery and well being	Recovery and well being recorded via recovery stress questionnaire (REST-Q)	2 weeks
Secondary	Sleep quality	Sleep quality determined via 'Pittsburgh Sleep Quality Index survey'	2 weeks