UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061913 |
|---|---|
| Receipt number | R000070844 |
| Scientific Title | Research on development of nutritional status estimation logic using urine tests and questionnaires and its applicability to specific health guidance |
| Date of disclosure of the study information | 2026/06/20 |
| Last modified on | 2026/06/15 15:03:53 |
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Basic information
Public title
Evaluative study on nutritional status estimation and specific health guidance program using urine tests and questionnaires
Acronym
Urine & Questionnaire Nutrition Guidance Study
Scientific Title
Research on development of nutritional status estimation logic using urine tests and questionnaires and its applicability to specific health guidance
Scientific Title:Acronym
Nutritional Estimation and Guidance Study
Region
| Japan |
Condition
Condition
To evaluatively assess the validity of a nutrient dietary intake estimation logic combining instant urine test data and questionnaire responses, and to exploratorily evaluate the efficacy of an individualized dietary guidance program utilizing the logic.
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy, Feasibility
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Validity of the dietary intake estimation logic (consistency and correlation between estimated nutrient intake and nutrient intake calculated from dietary photo records).
2. Feasibility of the specific health guidance program (changes from baseline to 3 months in urine test scores, weight, waist circumference, and BMI).
Key secondary outcomes
Changes in estimated dietary intake, changes in questionnaire scores related to dietary and lifestyle habits, and adherence status of dietary photo records
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
During the 3-month study period, a total of 3 urine tests using the Yuurea app, dietary photo/weight/waist circumference recording on the eat+ app, 3 questionnaire responses, and a total of 3 individualized dietary guidance sessions by registered dietitians will be conducted.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Individuals who understand the purpose of this study and voluntarily consent to participate.
2. Employees of the research sponsor (including those eligible for specific health guidance) or general public participants aged 20 and over.
Key exclusion criteria
1. Individuals taking diabetes medications (GLP-1 receptor agonists, insulin preparations, SGLT2 inhibitors, etc.).
2. Individuals taking antihypertensive drugs (ACE inhibitors, ARBs, diuretics, etc.).
3. Individuals with renal dysfunction or serious illness who are under dietary restrictions by a physician.
4. Individuals who find it difficult to operate smartphones, or who are expected to have difficulty continuing due to long-term business trips, etc.
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Takezawa |
Organization
Toyoda Gosei Co., Ltd.
Division name
New Value Creation Dept.
Zip code
452-8564
Address
1 Haruhi-nagahata, Kiyosu-shi, Aichi
TEL
052-400-1151
info@yuurea.co.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Takezawa |
Organization
Toyoda Gosei Co., Ltd.
Division name
New Value Creation Dept.
Zip code
452-8564
Address
1 Haruhi-nagahata, Kiyosu-shi, Aichi
TEL
052-400-1151
Homepage URL
info@yuurea.co.jp
Sponsor or person
Institute
Toyoda Gosei Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Toyoda Gosei 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
Research Ethics Committee of Yuurea Co., Ltd.
Address
3F Nagono Campus, 2-14-1 Nagono, Nishi-ku, Nagoya-shi, Aichi
Tel
-
-
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 | 06 | Month | 20 | 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
| 2026 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 15 | Day |
Last modified on
| 2026 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070844
