Chrononutrition of Using L-tryptophan Supplementation to Alleviate the Impacts of Night Shift Rotation on Circadian Hormones and Health Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Melatonin level in the morning
研究概览
简要总结
This randomized cross-over double-blinded trial aims to investigate the health effect of oral l-tryptophan supplementation on workers who rotate night shift work, and to examine the influences of different frequencies and timings of supplementation on the health effects.
详细描述
This study aims to investigate the health effect of oral l-tryptophan supplementation on workers who rotate night shift work, and to examine the influences of different frequencies and timings of supplementation on the health effects. Night shift work affects melatonin and cortisol variation, insomnia, mood issues, and metabolic syndrome. Short-term tryptophan supplementation was shown to improve melatonin, sleep quality, and cortisol response to acute stress. Little is known whether a longer term of longer-term tryptophan supplementation would alleviate the health impacts of night shift work. Nevertheless, melatonin and cortisol have their normal circadian patterns. Nothing is known about what temporal structure of tryptophan supplement would maximize its health effects on night shift workers melatonin and cortisol levels. We will conduct a double-blind cross-over randomized controlled trial to examine the benefits of oral tryptophan administration (3g/day, t.i.d.) on night shift workers' health outcomes: melatonin and cortisol levels, sleep quality, moods and work performance. We expect to reveal the health effect of tryptophan supplementation in night shift workers by using sophisticated study design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: adults >=20 y/o
- •Adults who had night shift schedule >1 month before enrollment, and will have similar night shift schedule in the following 2 months. (Eligible night shift schedule: >1 day of evening or night shift in a week)
- •People who will not have plans to travel to another time zone in the following 2-3 months
- •People who will plan to stay in the same job position for the following 3 months
- •People who have no experience in taking tryptophan or melatonin supplement in the past month
- •Body weight >= 50kg and <=80kg
- •Non-pregnant, non-breastfeeding, not taking contraceptives
- •Not under treatment of steroids, not taking sleeping pills
排除标准
- •diagnosis of renal or liver diseases
- •diagnosis of Cushing's Disease, Addison's disease
- •psychiatric diagnosis, such as depression and anxiety disorders
- •neurological diseases such as dementia, epilepsy, Parkinson's disease
研究组 & 干预措施
Tryptophan supplement
- Pure L-tryptophan in capsules (500mg/capsule)
- 3g tryptophan per day (2 capsules, t.i.d.), at 8AM, 4PM, and 0AM (± 1 hour)
干预措施: Tryptophan supplement (Dietary Supplement)
Maltose
- Placebo is maltose powder capsule (500mg/capsule)
- 3g maltose powder per day (2 capsules, t.i.d.), at 8AM, 4PM, and 0AM (± 1 hour)
干预措施: Maltose (Dietary Supplement)
结局指标
主要结局
Melatonin level in the morning
时间窗: 3 weeks
Morning (8AM) saliva melatonin level change in the phase
Melatonin level in the afternoon
时间窗: 3 weeks
Afternoon (4PM) saliva melatonin level change in the phase
Melatonin level at midnight
时间窗: 3 weeks
Midnight (0AM) saliva melatonin level change in the phase
Cortisol level in the morning
时间窗: 3 weeks
Morning (8AM) saliva cortisol level change in the phase
Cortisol level in the afternoon
时间窗: 3 weeks
Afternoon (4PM) saliva cortisol level change in the phase
Cortisol level at midnight
时间窗: 3 weeks
Midnight (0AM) saliva cortisol level change in the phase
次要结局
- Mood states, stress(3 weeks)
- Sleep quality(3 weeks)
- Mood states, depression(3 weeks)
- Mood states, anxiety(3 weeks)
研究者
Hsin-Jen Chen
Associate Professor
National Yang Ming Chiao Tung University