Effect of a Novel Melatonin Supplement on Sleep Quality
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Pharmacokinetic
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Coded, known only to manufacturer / collaborator
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18-40
- •Sometimes have trouble sleeping (Pittsburgh sleep quality index score >5)
排除标准
- •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
结局指标
主要结局
Pharmacokinetic
时间窗: 10 hours
Serum melatonin concentration area under curve
Sleep efficiency
时间窗: 2 weeks
Sleep efficiency, as total time asleep as percentage of time in bed
次要结局
- Sleep diary(2 weeks)
- Recovery and well being(2 weeks)
- Sleep quality(2 weeks)