Tryptophan Supplementation to Improve Night Shift Workers' Health

NCT04505800 | Completed

• 1 other identifier: YM106114F
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep; Mood; Burnout; Melatonin Deficiency; Cortisol Deficiency

Keywords

tryptophan; shift work; randomized trial; melatonin; cortisol

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• Sleep quality

  3 weeks

• Mood states, depression

  3 weeks

• Mood states, anxiety

  3 weeks

• Mood states, stress

  3 weeks

Study Arms (2)

Tryptophan supplement

EXPERIMENTAL

* 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

Maltose

PLACEBO COMPARATOR

* 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

Interventions

Tryptophan supplement 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)

Tryptophan supplement

Maltose DIETARY_SUPPLEMENT

Maltose

Maltose

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

National Yang-Ming University

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Burnout, Psychological

Interventions

Maltose

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Glucans; Polysaccharides; Carbohydrates; Disaccharides; Oligosaccharides; Sugars

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: August 10, 2020
• Study Start: September 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: December 31, 2020
• Last Updated: March 22, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)