UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044174 |
|---|---|
| Receipt number | R000050446 |
| Scientific Title | Elucidation of the relationship between food intake or blood levels of antioxidants and health condition (various disease markers and exercise functions) |
| Date of disclosure of the study information | 2021/05/20 |
| Last modified on | 2021/05/11 15:42:30 |
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Basic information
Public title
Elucidation of the relationship between food intake or blood levels of antioxidants and health condition (various disease markers and exercise functions)
Acronym
Elucidation of the relationship between food intake and levels of various health diagnostic markers
Scientific Title
Elucidation of the relationship between food intake or blood levels of antioxidants and health condition (various disease markers and exercise functions)
Scientific Title:Acronym
Elucidation of the relationship between food intake and levels of various health diagnostic markers
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the relationship between food intake or blood levels of antioxidants and health condition (various disease markers and exercise functions).
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationships between dietary intake determined by a food frequency questionnaire and internal levels of food ingredients and levels of measurements and biomarkers (e.g., lipopolysaccharide-binding protein (LBP)) related to health condition. (The data obtained at an annual health check-up between 2015 to 2021 for local residents will be analyzed.)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)20 years of age or older, living in the Iwaki area of Hirosaki City, Aomori Prefecture, Japan.
(2) Those who have fully understood the purpose and content of this study and have agreed to participate in.
Key exclusion criteria
None
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Shigeyuki |
| Middle name | |
| Last name | Nakaji |
Organization
Hirosaki University
Division name
Innovation Center for Health Promotion
Zip code
036-8562
Address
5 Zaifu-cho Hirosaki, Aomori 036-8562, Japan
TEL
0172-39-5041
nakaji@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Suganuma |
Organization
KAGOME CO., LTD.
Division name
Innovation Division
Zip code
329-2762
Address
17 Nishitomiyama Nasushiobara, Tochigi 329-2762, Japan
TEL
0287-36-2935
Homepage URL
Hiroyuki_Suganuma@kagome.co.jp
Sponsor or person
Institute
KAGOME CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Hirosaki University
Name of secondary funder(s)
Hirosaki University
IRB Contact (For public release)
Organization
Ethics committee of Hirosaki University Grauate School of Medicine
Address
5 Zaifu-cho Hirosaki, Aomori 036-8562, Japan
Tel
0172-39-5043
rinri@hirosaki-u.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
弘前大学院医学研究科附属健康未来イノベーションセンター（青森県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 09 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The data obtained at an annual health check-up between 2015 to 2021 for the residents of Iwaki area of Hirosaki city, Aomori prefecture will be analyzed to clarify the relationships between food intakes and health conditions.
Management information
Registered date
| 2021 | Year | 05 | Month | 11 | Day |
Last modified on
| 2021 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050446
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
