Sleep
Conditions
Keywords
melatonin, pharmacokinetics, sleep quality
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.
Interventions
DIETARY_SUPPLEMENTMelatonin
5mg melatonin supplement, once daily, from Ritual BioSeries
DIETARY_SUPPLEMENTPlacebo supplement
Placebo supplement, once daily, from Ritual BioSeries
Sponsors
Ritual Inc.
University of Exeter
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Coded, known only to manufacturer / collaborator
Intervention model description
Randomised cross over trial counterbalanced for trial order
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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' |
Countries
United Kingdom
Outcome results
None listed