UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050889 |
|---|---|
| Receipt number | R000057999 |
| Scientific Title | Elucidating the relationship between blood biomarker levels and deterioration in Health Status -The prospective cohort study of Kagome employees- |
| Date of disclosure of the study information | 2023/04/21 |
| Last modified on | 2023/12/13 17:40:21 |
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Basic information
Public title
Elucidating the relationship between blood biomarker levels and deterioration in Health Status
-The prospective cohort study of Kagome employees-
Acronym
Elucidating the relationship between blood biomarker levels and deterioration in Health Status
-The prospective cohort study of Kagome employees-
Scientific Title
Elucidating the relationship between blood biomarker levels and deterioration in Health Status
-The prospective cohort study of Kagome employees-
Scientific Title:Acronym
Elucidating the relationship between blood biomarker levels and deterioration in Health Status
-The prospective cohort study of Kagome employees-
Region
| Japan |
Condition
Condition
Medicine in general
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the relationship between blood biomarker levels and changes in each health-related indicator. Evaluate the correlation between blood biomarker levels and each health-related indicator annually.
Basic objectives2
Others
Basic objectives -Others
The evaluation is whether blood biomarker levels can be a predictive marker for risk of future disease.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The relationship between blood biomarker levels in the first year and changes in each health-related indicator during the study period
Key secondary outcomes
Relationship between changes in blood biomarker levels during the study period and changes in each health-related indicator during the study period and the correlation between blood biomarker levels and each health-related indicator
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Male and Female between the ages of 20 and 60
Key exclusion criteria
1)Persons whose health may be endangered by blood sampling and who have not had blood sampled during regular periodic health examinations.
2)Those who are unable to participate in the study for more than two years at the time of study entry due to age or other reasons.
3)Those who are considered inappropriate by principal investigator.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Ushida |
Organization
KAGOME CO., LTD.
Division name
Innovatiou Division, Diet & Well-being Research Department
Zip code
3292762
Address
17, Nishitomiyama, Nasushiobara-shi, Tochigi
TEL
0287362935
Yusuke_Ushida@kagome.co.jp
Public contact
Name of contact person
| 1st name | Haruka |
| Middle name | |
| Last name | Yoshida |
Organization
KAGOME Co., LTD
Division name
Innovatiou Division, Diet & Well-being Research Department
Zip code
3292762
Address
17, Nishitomiyama, Nasushiobara-shi, Tochigi
TEL
0287362935
Homepage URL
Haruka_Yoshida@kagome.co.jp
Sponsor or person
Institute
KAGOME Co., LTD
Institute
Department
Personal name
Funding Source
Organization
KAGOME CO., LTD.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagome Co.,LTD. Research Ethics Review Committee
Address
3-21-1 Nihonbashihamacho. chuo-ku, Tokyo
Tel
0356238501
Toshika_Okuni@kagome.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2023-R03
Org. issuing International ID_1
Kagome Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
カゴメ株式会社総合研究所(栃木県)、カゴメ株式会社那須工場（栃木県）、カゴメ株式会社茨城工場（茨城県）、カゴメ株式会社富士見工場（長野県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 21 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 02 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 24 | Day |
Last follow-up date
| 2032 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluate the relationship between blood biomarker levels and changes in each health-related indicator.
Evaluate the correlation between blood biomarker levels and each health-related indicator annually.
Management information
Registered date
| 2023 | Year | 04 | Month | 19 | Day |
Last modified on
| 2023 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057999
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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