UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045416 |
|---|---|
| Receipt number | R000051854 |
| Scientific Title | Development and verification of a new dietary instruction using two biomarkers |
| Date of disclosure of the study information | 2021/09/10 |
| Last modified on | 2023/03/10 13:09:35 |
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Basic information
Public title
Development and verification of a new dietary instruction using two biomarkers
Acronym
Development and verification of a new dietary instruction using two biomarkers
Scientific Title
Development and verification of a new dietary instruction using two biomarkers
Scientific Title:Acronym
Development and verification of a new dietary instruction using two biomarkers
Region
| Japan |
Condition
Condition
Healthy subject
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify a new dietary instruction besed on two biomarkers by comparing measured levels of biomarkers with dietary survey results
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measured levels of biomarker A and B
Dietary suvey results
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Subjects who agree to participate in this study with a written informed consent
Key exclusion criteria
Subjects with fever of 37.5C or higher on the day of the examination
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Ushida |
Organization
KAGOME CO., LTD.
Division name
Innovation Division
Zip code
329-2762
Address
17 Nishitomiyama, Nasushiobara-shi, Tochigi
TEL
0287-36-2935
Yusuke_Ushida@kagome.co.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Ushida |
Organization
KAGOME CO., LTD.
Division name
Innovation Division
Zip code
329-2762
Address
17 Nishitomiyama, Nasushiobara-shi, Tochigi
TEL
0287-36-2935
Homepage URL
Yusuke_Ushida@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
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagome Ethics Committee
Address
3-21-1 Nihombashihamacho, Chuo-ku, Tokyo
Tel
03-5623-8501
Takuji_Hayakawa@kagome.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2021-R09
Org. issuing International ID_1
Kagome Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
カゴメ株式会社イノベーション本部、那須工場（栃木県）、北海道支店（北海道）、東北支店（宮城県）、東京本社、水天宮ビル（東京都）、本社、名古屋支店（愛知県）、大阪支店（大阪府）、中四国支店（広島県）、九州支店（福岡県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | 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
240
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
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 02 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Two biomarker levels and dietary survey results
Management information
Registered date
| 2021 | Year | 09 | Month | 07 | Day |
Last modified on
| 2023 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051854
