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| Name | Class |
|---|---|
| Ritual Inc. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin supplementation | Experimental | 5mg melatonin supplement from Ritual Inc's BioSeries |
|
| Placebo supplementation | Placebo Comparator | Placebo supplement from Ritual Inc. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin | Dietary Supplement | 5mg melatonin supplement, once daily, from Ritual BioSeries |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep diary | Sleep diary recorded daily via 'consensus sleep diary - core' | 2 weeks |
| Recovery and well being | Recovery and well being recorded via recovery stress questionnaire (REST-Q) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francis B Stephens, PhD | University of Exeter | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sport & Health Sciences University of Exeter | Exeter | Devon | EX1 2LU | United Kingdom |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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Randomised cross over trial counterbalanced for trial order
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Coded, known only to manufacturer / collaborator
| Placebo supplement | Dietary Supplement | Placebo supplement, once daily, from Ritual BioSeries |
|
| 2 weeks |
| Sleep quality | Sleep quality determined via 'Pittsburgh Sleep Quality Index survey' | 2 weeks |
| D001523 |
| Mental Disorders |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |