Tryptophan Supplementation to Improve Night Shift Workers' Health

NCT ID: NCT04505800

Last Updated: 2021-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2020-12-31

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.

Conditions

Sleep; Mood; Burnout; Melatonin Deficiency; Cortisol Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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)

Group Type: EXPERIMENTAL

Tryptophan supplement

Intervention Type: DIETARY_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

• Placebo is maltose powder capsule (500mg/capsule)
• 3g maltose powder per day (2 capsules, t.i.d.), at 8AM, 4PM, and 0AM (± 1 hour)

Group Type: PLACEBO_COMPARATOR

Maltose

Intervention Type: DIETARY_SUPPLEMENT

Maltose

Interventions

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)

Intervention Type: DIETARY_SUPPLEMENT

Maltose

Maltose

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Yang Ming Chiao Tung University

OTHER

Sponsor Role: lead

Responsible Party

Hsin-Jen Chen

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Yang-Ming University

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

YM106114F

Identifier Type: -

Identifier Source: org_study_id