UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054240 |
|---|---|
| Receipt number | R000061932 |
| Scientific Title | Effects of oral intake of liposomal lactoferrin on jet lag and sleep quality of JTB group tour conductors |
| Date of disclosure of the study information | 2024/12/01 |
| Last modified on | 2024/05/07 19:08:51 |
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Basic information
Public title
The effect of Kenko Dojo lactoferrin on jet lag and travel fatigue symptoms of tour conductors: Preliminary survey
Acronym
The effect of lactoferrin on jet lag and travel fatigue symptoms of tour conductors: Preliminary survey
Scientific Title
Effects of oral intake of liposomal lactoferrin on jet lag and sleep quality of JTB group tour conductors
Scientific Title:Acronym
Effects of oral intake of liposomal lactoferrin on jet lag and sleep quality of JTB group tour conductors
Region
| Japan |
Condition
Condition
JETLAG
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Tour conductors often travel abroad and suffer from jet lag symptoms (poor sleep, gastrointestinal problems, poor performance, etc.) and travel fatigue. This study aimed to determine whether orally administration of lactoferrin, which has anti-inflammatory properties, can alleviate jet lag symptoms and sleep quality in tour operators.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Actigraphic assessment (Sleep Latency, Total Counts, Sleep Efficiency, Total Minutes in Bed, Total Sleep Time, Wake After Sleep Onset, Number of Awakenings, Average Awakening Length)
Key secondary outcomes
Liverpool Jetlag Questionnaire, Oguri-Shirakawa-Azumi Sleep Inventory, Middle-Aged version (OSA-MA)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
administration of liposomal lactoferrin (270 mg lactoferrin/day) for 21 days
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Persons accompanying overseas travelers more than once during the survey period
Persons who have experienced jet lag or travel fatigue and show these symptoms relatively frequently
Key exclusion criteria
Those who consumed food/supplements containing at least 100 mg of lactoferrin within 2 weeks before the start of the study.
Those who have a history of allergic reactions to the test foods (milk, soybeans)
Persons who are unable to follow the procedures of various surveys conducted during the survey period (e.g. filling out various survey forms, wearing an Actigraph, etc.)
Persons judged to be unsuitable as monitors based on the answers to the preliminary questionnaire
Those who are participating in other clinical studies at the start of this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Suwa |
Organization
Sunstar Inc.
Division name
R&D Department
Zip code
569-1195
Address
3-1 Asahicho, Takatsuki City, Osaka Prefecture
TEL
+81-72-682-5570
makoto.suwa@jp.sunstar.com
Public contact
Name of contact person
| 1st name | Shoko |
| Middle name | |
| Last name | Uesaki |
Organization
Sunstar Inc.
Division name
R&D Department
Zip code
569-1195
Address
3-1 Asahicho, Takatsuki City, Osaka Prefecture
TEL
+81-72-682-5570
Homepage URL
syoko.uesaki@jp.sunstar.com
Sponsor or person
Institute
Sunstar Inc.
Institute
Department
Personal name
Funding Source
Organization
Sunstar Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Validity Assessment Committee for Clinical Research
Address
1-17 Koyochonaka, Higshinadaku, Kobe City, Hyogo Prefecture
Tel
+81-80-8335-9125
takeshi.kanamori@jp.sunstar.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
14
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
We are currently preparing the paper for submission.
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 09 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 23 | Day |
Last modified on
| 2024 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061932
