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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04505800
Other study ID # YM106114F
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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