Tryptophan Supplementation to Improve Night Shift Workers' Health

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04505800
• Other study ID #: YM106114F
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2021
• Source: National Yang Ming University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Burnout
• Burnout, Psychological
• Cortisol Deficiency
• Melatonin Deficiency
• Mood
• Sleep

Intervention

Dietary Supplement:
• 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)
• Maltose
Maltose

Locations

Country	Name	City	State
Taiwan	National Yang-Ming University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

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