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Tryptophan Supplementation to Improve Night Shift Workers' Health

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ClinicalTrials.gov Identifier: NCT04505800
Recruitment Status : Completed
First Posted : August 10, 2020
Last Update Posted : March 22, 2021
Sponsor:
Information provided by (Responsible Party):
Hsin-Jen Chen, National Yang Ming University

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.

Condition or disease Intervention/treatment Phase
Sleep Mood Burnout Melatonin Deficiency Cortisol Deficiency Dietary Supplement: Tryptophan supplement Dietary Supplement: Maltose Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Chrononutrition of Using L-tryptophan Supplementation to Alleviate the Impacts of Night Shift Rotation on Circadian Hormones and Health Outcomes
Actual Study Start Date : September 1, 2019
Actual Primary Completion Date : September 1, 2020
Actual Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Tryptophan

Arm Intervention/treatment
Experimental: 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)
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)

Placebo Comparator: 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)
Dietary Supplement: Maltose
Maltose




Primary Outcome Measures :
  1. Melatonin level in the morning [ Time Frame: 3 weeks ]
    Morning (8AM) saliva melatonin level change in the phase

  2. Melatonin level in the afternoon [ Time Frame: 3 weeks ]
    Afternoon (4PM) saliva melatonin level change in the phase

  3. Melatonin level at midnight [ Time Frame: 3 weeks ]
    Midnight (0AM) saliva melatonin level change in the phase

  4. Cortisol level in the morning [ Time Frame: 3 weeks ]
    Morning (8AM) saliva cortisol level change in the phase

  5. Cortisol level in the afternoon [ Time Frame: 3 weeks ]
    Afternoon (4PM) saliva cortisol level change in the phase

  6. Cortisol level at midnight [ Time Frame: 3 weeks ]
    Midnight (0AM) saliva cortisol level change in the phase


Secondary Outcome Measures :
  1. Sleep quality [ Time Frame: 3 weeks ]
    Pittsburg Sleep Quality Score (range: 0-21) at the end of the phase. The higher score indicates worse sleep quality

  2. Mood states, depression [ Time Frame: 3 weeks ]
    Depression, Anxiety, Stress Scales. Depression score (range 0-42) changes in the phase. The higher score, the more depressed.

  3. Mood states, anxiety [ Time Frame: 3 weeks ]
    Depression, Anxiety, Stress Scales. Anxiety score (range 0-42) changes in the phase. The higher score, the more anxious.

  4. Mood states, stress [ Time Frame: 3 weeks ]
    Depression, Anxiety, Stress Scales. Stress score (range 0-42) changes in the phase. The higher score, the more stressful.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04505800


Locations
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Taiwan
National Yang-Ming University
Taipei, Taiwan, 112
Sponsors and Collaborators
National Yang Ming University
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Responsible Party: Hsin-Jen Chen, Associate Professor, National Yang Ming University
ClinicalTrials.gov Identifier: NCT04505800    
Other Study ID Numbers: YM106114F
First Posted: August 10, 2020    Key Record Dates
Last Update Posted: March 22, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The participants did not provide agreement to the researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hsin-Jen Chen, National Yang Ming University:
tryptophan
shift work
randomized trial
melatonin
cortisol
Additional relevant MeSH terms:
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Burnout, Psychological
Stress, Psychological
Behavioral Symptoms
Tryptophan
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs