Effect of a Novel Melatonin Supplement on Sleep Quality
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Exeter
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Sleep efficiency
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Coded, known only to manufacturer / collaborator
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Arms & Interventions
Placebo supplementation
Placebo supplement from Ritual Inc.
Intervention: Placebo supplement (Dietary Supplement)
Melatonin supplementation
5mg melatonin supplement from Ritual Inc's BioSeries
Intervention: Melatonin (Dietary Supplement)
Outcomes
Primary Outcomes
Sleep efficiency
Time Frame: 2 weeks
Sleep efficiency, as total time asleep as percentage of time in bed
Pharmacokinetic
Time Frame: 10 hours
Serum melatonin concentration area under curve
Secondary Outcomes
- Sleep quality(2 weeks)
- Sleep diary(2 weeks)
- Recovery and well being(2 weeks)