Tryptophan Supplementation to Improve Night Shift Workers' Health
Primary Purpose
Sleep, Mood, Burnout
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Tryptophan supplement
Maltose
Sponsored by
About this trial
This is an interventional prevention trial for Sleep focused on measuring tryptophan, shift work, randomized trial, melatonin, cortisol
Eligibility Criteria
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
Sites / Locations
- National Yang-Ming University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tryptophan supplement
Maltose
Arm Description
Pure L-tryptophan in capsules (500mg/capsule) 3g tryptophan per day (2 capsules, t.i.d.), at 8AM, 4PM, and 0AM (± 1 hour)
Placebo is maltose powder capsule (500mg/capsule) 3g maltose powder per day (2 capsules, t.i.d.), at 8AM, 4PM, and 0AM (± 1 hour)
Outcomes
Primary Outcome Measures
Melatonin level in the morning
Morning (8AM) saliva melatonin level change in the phase
Melatonin level in the afternoon
Afternoon (4PM) saliva melatonin level change in the phase
Melatonin level at midnight
Midnight (0AM) saliva melatonin level change in the phase
Cortisol level in the morning
Morning (8AM) saliva cortisol level change in the phase
Cortisol level in the afternoon
Afternoon (4PM) saliva cortisol level change in the phase
Cortisol level at midnight
Midnight (0AM) saliva cortisol level change in the phase
Secondary Outcome Measures
Sleep quality
Pittsburg Sleep Quality Score (range: 0-21) at the end of the phase. The higher score indicates worse sleep quality
Mood states, depression
Depression, Anxiety, Stress Scales. Depression score (range 0-42) changes in the phase. The higher score, the more depressed.
Mood states, anxiety
Depression, Anxiety, Stress Scales. Anxiety score (range 0-42) changes in the phase. The higher score, the more anxious.
Mood states, stress
Depression, Anxiety, Stress Scales. Stress score (range 0-42) changes in the phase. The higher score, the more stressful.
Full Information
NCT ID
NCT04505800
First Posted
June 23, 2020
Last Updated
March 19, 2021
Sponsor
National Yang Ming University
1. Study Identification
Unique Protocol Identification Number
NCT04505800
Brief Title
Tryptophan Supplementation to Improve Night Shift Workers' Health
Official Title
Chrononutrition of Using L-tryptophan Supplementation to Alleviate the Impacts of Night Shift Rotation on Circadian Hormones and Health Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Yang Ming University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep, Mood, Burnout, Melatonin Deficiency, Cortisol Deficiency
Keywords
tryptophan, shift work, randomized trial, melatonin, cortisol
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tryptophan supplement
Arm Type
Experimental
Arm Description
Pure L-tryptophan in capsules (500mg/capsule)
3g tryptophan per day (2 capsules, t.i.d.), at 8AM, 4PM, and 0AM (± 1 hour)
Arm Title
Maltose
Arm Type
Placebo Comparator
Arm Description
Placebo is maltose powder capsule (500mg/capsule)
3g maltose powder per day (2 capsules, t.i.d.), at 8AM, 4PM, and 0AM (± 1 hour)
Intervention Type
Dietary Supplement
Intervention Name(s)
Tryptophan supplement
Intervention Description
Pure L-tryptophan in capsules (500mg/capsule)
3g tryptophan per day (2 capsules, t.i.d.), at 8AM, 4PM, and 0AM (± 1 hour)
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltose
Intervention Description
Maltose
Primary Outcome Measure Information:
Title
Melatonin level in the morning
Description
Morning (8AM) saliva melatonin level change in the phase
Time Frame
3 weeks
Title
Melatonin level in the afternoon
Description
Afternoon (4PM) saliva melatonin level change in the phase
Time Frame
3 weeks
Title
Melatonin level at midnight
Description
Midnight (0AM) saliva melatonin level change in the phase
Time Frame
3 weeks
Title
Cortisol level in the morning
Description
Morning (8AM) saliva cortisol level change in the phase
Time Frame
3 weeks
Title
Cortisol level in the afternoon
Description
Afternoon (4PM) saliva cortisol level change in the phase
Time Frame
3 weeks
Title
Cortisol level at midnight
Description
Midnight (0AM) saliva cortisol level change in the phase
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Sleep quality
Description
Pittsburg Sleep Quality Score (range: 0-21) at the end of the phase. The higher score indicates worse sleep quality
Time Frame
3 weeks
Title
Mood states, depression
Description
Depression, Anxiety, Stress Scales. Depression score (range 0-42) changes in the phase. The higher score, the more depressed.
Time Frame
3 weeks
Title
Mood states, anxiety
Description
Depression, Anxiety, Stress Scales. Anxiety score (range 0-42) changes in the phase. The higher score, the more anxious.
Time Frame
3 weeks
Title
Mood states, stress
Description
Depression, Anxiety, Stress Scales. Stress score (range 0-42) changes in the phase. The higher score, the more stressful.
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
National Yang-Ming University
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The participants did not provide agreement to the researchers.
Learn more about this trial
Tryptophan Supplementation to Improve Night Shift Workers' Health
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