Tryptophan Supplementation to Improve Night Shift Workers' Health

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Chrononutrition of Using L-tryptophan Supplementation to Alleviate the Impacts of Night Shift Rotation on Circadian Hormones and Health Outcomes

Conditions
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Sleep, Mood, Burnout, Melatonin Deficiency, Cortisol Deficiency

Intervention / Treatment
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* Dietary Supplement: Tryptophan supplement
* Dietary Supplement: Maltose


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 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 Exclusion criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tryptophan supplement<br>Pure L-tryptophan in capsules (500mg/capsule) 3g tryptophan per day (2 capsules, t.i.d.), at 8AM, 4PM, and 0AM (± 1 hour) | Dietary Supplement: Tryptophan supplement<br>* Pure L-tryptophan in capsules (500mg/capsule) 3g tryptophan per day (2 capsules, t.i.d.), at 8AM, 4PM, and 0AM (± 1 hour)<br>|
| Placebo Comparator: Maltose<br>Placebo is maltose powder capsule (500mg/capsule) 3g maltose powder per day (2 capsules, t.i.d.), at 8AM, 4PM, and 0AM (± 1 hour) | Dietary Supplement: Maltose<br>* Maltose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Melatonin level in the morning | Morning (8AM) saliva melatonin level change in the phase | 3 weeks | 
| Melatonin level in the afternoon | Afternoon (4PM) saliva melatonin level change in the phase | 3 weeks | 
| Melatonin level at midnight | Midnight (0AM) saliva melatonin level change in the phase | 3 weeks | 
| Cortisol level in the morning | Morning (8AM) saliva cortisol level change in the phase | 3 weeks | 
| Cortisol level in the afternoon | Afternoon (4PM) saliva cortisol level change in the phase | 3 weeks | 
| Cortisol level at midnight | Midnight (0AM) saliva cortisol level change in the phase | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep quality | Pittsburg Sleep Quality Score (range: 0-21) at the end of the phase. The higher score indicates worse sleep quality | 3 weeks | 
| Mood states, depression | Depression, Anxiety, Stress Scales. Depression score (range 0-42) changes in the phase. The higher score, the more depressed. | 3 weeks | 
| Mood states, anxiety | Depression, Anxiety, Stress Scales. Anxiety score (range 0-42) changes in the phase. The higher score, the more anxious. | 3 weeks | 
| Mood states, stress | Depression, Anxiety, Stress Scales. Stress score (range 0-42) changes in the phase. The higher score, the more stressful. | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tryptophan, shift work, randomized trial, melatonin, cortisol