SleepNCT04505800
Tryptophan Supplementation to Improve Night Shift Workers' Health
A study testing Tryptophan supplement and Maltose in people with Sleep and Mood, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- What is being tested?
- Tryptophan supplement and Maltose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chrononutrition of Using L-tryptophan Supplementation to Alleviate the Impacts of Night Shift Rotation on Circadian Hormones and Health Outcomes
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.
Read the 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
- Being tested
- Tryptophan supplement, Maltose
- Keywords
- tryptophan, shift work, randomized trial, melatonin, cortisol
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tryptophan supplementDietary supplement
- Pure L-tryptophan in capsules (500mg/capsule)
- 3g tryptophan per day (2 capsules, t.i.d.), at 8AM, 4PM, and 0AM (± 1 hour)
MaltoseDietary supplement
Maltose
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Dietary Supplement: Maltose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Melatonin level in the morning
Morning (8AM) saliva melatonin level change in the phase
Measured: 3 weeks
Melatonin level in the afternoon
Afternoon (4PM) saliva melatonin level change in the phase
Measured: 3 weeks
Melatonin level at midnight
Midnight (0AM) saliva melatonin level change in the phase
Measured: 3 weeks
Cortisol level in the morning
Morning (8AM) saliva cortisol level change in the phase
Measured: 3 weeks
Cortisol level in the afternoon
Afternoon (4PM) saliva cortisol level change in the phase
Measured: 3 weeks
Cortisol level at midnight
Midnight (0AM) saliva cortisol level change in the phase
Measured: 3 weeks
Secondary outcomes (4)
Sleep quality
Pittsburg Sleep Quality Score (range: 0-21) at the end of the phase. The higher score indicates worse sleep quality
Measured: 3 weeks
Mood states, depression
Depression, Anxiety, Stress Scales. Depression score (range 0-42) changes in the phase. The higher score, the more depressed.
Measured: 3 weeks
Mood states, anxiety
Depression, Anxiety, Stress Scales. Anxiety score (range 0-42) changes in the phase. The higher score, the more anxious.
Measured: 3 weeks
Mood states, stress
Depression, Anxiety, Stress Scales. Stress score (range 0-42) changes in the phase. The higher score, the more stressful.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start1 Sep 2019
- Primary completion1 Sep 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsin-Jen Chen, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04505800
- Sponsor's protocol ID
- YM106114F
- Status last verified
- Mar 2021
- First submitted
- 23 Jun 2020
- Last updated
- 22 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The participants did not provide agreement to the researchers.
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chrononutrition of Using L-tryptophan Supplementation to Alleviate the Impacts of Night Shift Rotation on Circadian Hormones and Health Outcomes
- ClinicalTrials.gov ID
- NCT04505800
- Acronym / sponsor ID
- YM106114F
- Conditions
- Sleep, Mood, Burnout, Melatonin Deficiency, Cortisol Deficiency
- Keywords
- tryptophan, shift work, randomized trial, melatonin, cortisol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 10 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tryptophan supplement | Experimental | 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 | Placebo comparator | Dietary Supplement: 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) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
| MaltoseMaltose | Dietary supplement | Maltose |
Primary outcome
Melatonin level in the morning
Time frame: 3 weeks
Morning (8AM) saliva melatonin level change in the phase
Melatonin level in the afternoon
Time frame: 3 weeks
Afternoon (4PM) saliva melatonin level change in the phase
Melatonin level at midnight
Time frame: 3 weeks
Midnight (0AM) saliva melatonin level change in the phase
Cortisol level in the morning
Time frame: 3 weeks
Morning (8AM) saliva cortisol level change in the phase
Cortisol level in the afternoon
Time frame: 3 weeks
Afternoon (4PM) saliva cortisol level change in the phase
Cortisol level at midnight
Time frame: 3 weeks
Midnight (0AM) saliva cortisol level change in the phase
4 secondary outcomes
Sleep quality
Time frame: 3 weeks
Mood states, depression
Time frame: 3 weeks
Mood states, anxiety
Time frame: 3 weeks
Mood states, stress
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- Individual participant dataSharing planned: No. The participants did not provide agreement to the researchers.
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Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tryptophan supplement and Maltose in people with Sleep and Mood, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Melatonin level in the morning (time frame: 3 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021.