UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059725 |
|---|---|
| Receipt number | R000068171 |
| Scientific Title | Verification of dietary improvement and behavioral change among workplace employees through self-monitoring of urine analysis using a nutrition monitoring service |
| Date of disclosure of the study information | 2025/11/10 |
| Last modified on | 2025/10/30 18:48:36 |
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Basic information
Public title
Verification of dietary improvement and behavioral change among workplace employees through self-monitoring of urine analysis using a nutrition monitoring service
Acronym
Verification of dietary improvement and behavioral change among workplace employees through self-monitoring of urine analysis using a nutrition monitoring service
Scientific Title
Verification of dietary improvement and behavioral change among workplace employees through self-monitoring of urine analysis using a nutrition monitoring service
Scientific Title:Acronym
Verification of dietary improvement and behavioral change among workplace employees through self-monitoring of urine analysis using a nutrition monitoring service
Region
| Japan |
Condition
Condition
No specific disease
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the effects of a nutrition monitoring service that enables employees to self-measure urinary biomarkers (such as Na/K ratio, pH, specific gravity, hydration, vitamin C, magnesium, calcium, uric acid, and ketone bodies) on dietary improvement and behavior change among workplace employees.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change from baseline in dietary behavior and behavior modification level, as assessed by a food frequency questionnaire (FFQ) and a behavioral change stage questionnaire.
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Possess and can operate a smartphone
Able to understand the study explanation and provide informed consent
Approximately 160 participants are planned to be enrolled
Key exclusion criteria
Currently pregnant
Individuals with severe underlying diseases such as chronic kidney disease that may affect urinary components and require ongoing treatment
Individuals following strict therapeutic dietary restrictions
Individuals judged by the investigators to be unsuitable for study participation
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Michiyo |
| Middle name | |
| Last name | Kimura |
Organization
Takasaki University of Health and Welfare
Division name
Faculty of Health and Welfare
Zip code
370-0033
Address
37-1 Nakaorui-machi, Takasaki-shi, Gunma, Japan
TEL
027-352-1290
kimura@takasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Kinuko |
| Middle name | |
| Last name | Abe |
Organization
Japan Nutrition Practical Science Strategy Organization
Division name
Executive Office
Zip code
105-0004
Address
7th Floor, Shimbashi MCV Building, 5-13-5 Shimbashi, Minato-ku, Tokyo, 105-0004, Japan
TEL
03-3578-7700
Homepage URL
abe@dietitian.or.jp
Sponsor or person
Institute
Japan Nutrition Practical Science Strategy Organization
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd.
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
Takasaki University of Health and Welfare
Address
37-1 Nakaorui-machi, Takasaki-shi, Gunma, Japan
Tel
027-352-1290
mune
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
| 2025 | Year | 11 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2026 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 09 | Month | 30 | Day |
Other
Other related information
A urine analysis-based nutrition monitoring service is used to assess changes in dietary indicators and behavioral modification. Observation items include a food frequency questionnaire (FFQ), a behavioral change stage questionnaire, and nutrition scores derived from urine analysis. The intervention is designed for health promotion with minimal participant burden or invasiveness.
Management information
Registered date
| 2025 | Year | 11 | Month | 10 | Day |
Last modified on
| 2025 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068171
