UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052023 |
|---|---|
| Receipt number | R000059366 |
| Scientific Title | Study on the genetic background of blood and skin carotenoid levels |
| Date of disclosure of the study information | 2023/08/31 |
| Last modified on | 2024/09/02 10:09:47 |
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Basic information
Public title
Study on the genetic background of blood and skin carotenoid levels
Acronym
Study on the genetic background of blood and skin carotenoid levels
Scientific Title
Study on the genetic background of blood and skin carotenoid levels
Scientific Title:Acronym
Study on the genetic background of blood and skin carotenoid levels
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To assess the effect of genetic background on the blood and skin carotenoid levels.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Total blood carotenoid level
Skin carotenoid level
Key secondary outcomes
Individual blood carotenoid and vitamin levels (lutein, zeaxanthin, beta-cryptoxanthin, alpha-carotene, beta-carotene, lycopene, alpha-tocopherol, retinol, vitamin C)
Total vegetable intake
Individual vegetable intake
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
Participants whose genomic information is available from the Iwaki Health Promotion Project in 2015-2020.
Key exclusion criteria
1. Participants with missing data used in the study
2. Participants deviated from Japanese genomic information
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Itoh |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Vegetable Life Science
Zip code
036-8562
Address
5 Zaifu-cho, Hirosaki, Aomori 036-8562, Japan
TEL
0172-39-5512
itohk@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Itoh |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Vegetable Life Science
Zip code
036-8562
Address
5 Zaifu-cho, Hirosaki, Aomori 036-8562, Japan
TEL
0172-39-5512
Homepage URL
itohk@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
KAGOME CO., LTD.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Hirosaki University Graduate School of Medicine
Address
5 Zaifu-cho Hirosaki, Aomori 036-8562, Japan
Tel
0172-39-5044
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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 31 | 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
2081
Results
We found some variants correlated to serum carotenoid concentration. The genes in which some of these variants are located were reported to regulate mitochondrial function or high-density lipoprotein cholesterol amount, suggesting the mechanism of controlling serum carotenoid concentrations.
Results date posted
| 2024 | Year | 09 | Month | 02 | Day |
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
| 2023 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 08 | Month | 31 | Day |
Other
Other related information
This study aims to clarify the effect of genetic background on blood and skin carotenoid levels in the residents of Iwaki area of Hirosaki city, Aomori prefecture.
Management information
Registered date
| 2023 | Year | 08 | Month | 28 | Day |
Last modified on
| 2024 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059366
