UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062663 |
|---|---|
| Receipt number | R000071734 |
| Scientific Title | Taste Perception, Oral Function, and Body Composition among Manufacturing Workers Engaged in Night-Shift Work: A Prospective Observational Study |
| Date of disclosure of the study information | 2026/08/24 |
| Last modified on | 2026/08/24 11:01:51 |
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Basic information
Public title
Taste Perception, Oral Function, and Body Composition among Manufacturing Workers Engaged in Night-Shift Work: A Prospective Observational Study
Acronym
Study of Taste, Oral Function, and Body Composition in Manufacturing Workers Who Work Night Shifts
Scientific Title
Taste Perception, Oral Function, and Body Composition among Manufacturing Workers Engaged in Night-Shift Work: A Prospective Observational Study
Scientific Title:Acronym
Night-Shift Worker Taste and Oral Function Study
Region
| Japan |
Condition
Condition
Not applicable (healthy adults)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate taste sensitivity, body composition, bone density, and oral function, and to clarify the associations between taste sensitivity and these health-related factors.
Basic objectives2
Others
Basic objectives -Others
Among manufacturing workers including those engaged in night-shift work, umami and sweet taste recognition thresholds, oral function parameters (masticatory performance, maximum tongue pressure, and chewing behavior), body composition parameters (skeletal muscle mass, body fat percentage, and skeletal muscle mass index [SMI]), and bone density will be assessed. Associations among these parameters, as well as their relationships with age, sex, smoking, alcohol consumption, and work patterns, will be explored. Differences in these parameters according to the presence or absence of night-shift work or work patterns will also be examined.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Umami and sweet taste recognition thresholds, and their associations with oral function parameters (masticatory performance, maximum tongue pressure, and chewing behavior), body composition parameters (skeletal muscle mass, body fat percentage, and skeletal muscle mass index [SMI]), and bone density.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adult employees working at an automotive parts manufacturing company in Usa, Oita Prefecture, who provide informed consent to participate in the study after receiving an explanation of the study.
Key exclusion criteria
Individuals who do not provide consent to participate in the study, and those who report dental or oral discomfort, such as pain, at the time of measurement.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Atsuko |
| Middle name | |
| Last name | Nakamichi |
Organization
Kyushu Dental University
Division name
Department of Biochemistry, Division of Life Sciences
Zip code
803-8580
Address
2-6-1 Manazuru, Kokurakita-ku, Kitakyushu, Fukuoka 803-8580, Japan
TEL
093-285-3073
j25nakamichi@fa.kyu-dent.ac.jp
Public contact
Name of contact person
| 1st name | Atsuko |
| Middle name | |
| Last name | Nakamichi |
Organization
Kyushu Dental University
Division name
Department of Biochemistry, Division of Life Sciences
Zip code
803-8580
Address
2-6-1 Manazuru, Kokurakita-ku, Kitakyushu, Fukuoka 803-8580, Japan
TEL
093-285-3073
Homepage URL
j25nakamichi@fa.kyu-dent.ac.jp
Sponsor or person
Institute
Kyushu Dental University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS), KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu Dental University Research Ethics Committee
Address
2-6-1 Manazuru, Kokurakita-ku, Kitakyushu, Fukuoka 803-8580, Japan
Tel
093-285-3011
gakusei@kyu-dent.ac.jp
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
| 2026 | Year | 08 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2028 | Year | 08 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2026 | Year | 08 | Month | 24 | Day |
Last modified on
| 2026 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071734
