Sleep Clinical Trial
Official title:
Chrononutrition of Using L-tryptophan Supplementation to Alleviate the Impacts of Night Shift Rotation on Circadian Hormones and Health Outcomes
Verified date | March 2021 |
Source | National Yang Ming University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | December 31, 2020 |
Est. primary completion date | September 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | National Yang-Ming University | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Yang Ming University |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Melatonin level in the morning | Morning (8AM) saliva melatonin level change in the phase | 3 weeks | |
Primary | Melatonin level in the afternoon | Afternoon (4PM) saliva melatonin level change in the phase | 3 weeks | |
Primary | Melatonin level at midnight | Midnight (0AM) saliva melatonin level change in the phase | 3 weeks | |
Primary | Cortisol level in the morning | Morning (8AM) saliva cortisol level change in the phase | 3 weeks | |
Primary | Cortisol level in the afternoon | Afternoon (4PM) saliva cortisol level change in the phase | 3 weeks | |
Primary | Cortisol level at midnight | Midnight (0AM) saliva cortisol level change in the phase | 3 weeks | |
Secondary | Sleep quality | Pittsburg Sleep Quality Score (range: 0-21) at the end of the phase. The higher score indicates worse sleep quality | 3 weeks | |
Secondary | Mood states, depression | Depression, Anxiety, Stress Scales. Depression score (range 0-42) changes in the phase. The higher score, the more depressed. | 3 weeks | |
Secondary | Mood states, anxiety | Depression, Anxiety, Stress Scales. Anxiety score (range 0-42) changes in the phase. The higher score, the more anxious. | 3 weeks | |
Secondary | Mood states, stress | Depression, Anxiety, Stress Scales. Stress score (range 0-42) changes in the phase. The higher score, the more stressful. | 3 weeks |
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