UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048999 |
|---|---|
| Receipt number | R000055803 |
| Scientific Title | The relationship between skin carotenoid concentrations and genetic background |
| Date of disclosure of the study information | 2022/10/14 |
| Last modified on | 2024/03/05 13:54:53 |
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Basic information
Public title
The relationship between skin carotenoid concentrations and genetic background
Acronym
The relationship between skin carotenoid concentrations and genetic background
Scientific Title
The relationship between skin carotenoid concentrations and genetic background
Scientific Title:Acronym
The relationship between skin carotenoid concentrations and genetic background
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 association between skin carotenoid concentrations and genetic background in Japanese population.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Skin carotenoid concentration
Key secondary outcomes
Vegetable preference
Vegetable consumption
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. Men and women who are 20 years of age or older at the time of obtaining consent to participate in the study
2. Participants who have already given written informed consent to participate in the MYCODE study
3. Participants who have already obtained MYCODE test results
4. Participants who are able to attend and participate in the study on the study day
5. Participants who have fully explained the purpose and contents of this study, have the capacity to consent, understand these well, participate voluntarily, and are able to consent to participation in this study
Key exclusion criteria
Not applicable
Target sample size
550
Research contact person
Name of lead principal investigator
| 1st name | Shigenori |
| Middle name | |
| Last name | Suzuki |
Organization
KAGOME CO., LTD.
Division name
Innovation Division
Zip code
329-2762
Address
17 Nishitomiyama, Nasushiobara-shi, Tochigi
TEL
080-1573-5837
shigenori_suzuki@kagome.co.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Matsuda |
Organization
DeNA Life Science, Inc.
Division name
MYCODE service division
Zip code
150-0002
Address
Shibuya Scramble Square 2 Chome-24-12 Shibuya, Shibuya City, Tokyo
TEL
03-6811-0877
Homepage URL
research@mycode.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
Other related organizations
Co-sponsor
DeNA Life Science, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee of DLS Inc.
Address
Shibuya Scramble Square 2 Chome-24-12 Shibuya, Shibuya City, Tokyo
Tel
03-6811-0877
IRB_dls@dena.com
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
DeNA横浜オフィス（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 14 | Day |
Related information
URL releasing protocol
NA
Publication of results
Unpublished
Result
URL related to results and publications
NA
Number of participants that the trial has enrolled
507
Results
While the study did not identify any gene regions associated with skin carotenoid concentrations, five loci were identified that met the suggestive significance level.
Results date posted
| 2024 | Year | 03 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Members of the genetic testing service MYCODE who have given consent for research to be conducted using samples and information obtained through MYCODE
Participant flow
Among the members of the genetic testing service MYCODE, those who have given their consent to the research to be conducted using the samples and information obtained through MYCODE will be invited to participate in the study through web and email notifications. Members will review the explanatory content of the study, including the consent explanatory document, on the web and, if they fully understand the content and are willing to participate voluntarily, they will express their consent on the web. This consent is carried out on a webpage displayed exclusively for members, where they can log in by entering their MYCODE registered email address, password and secret question, and where only they can view the webpage. There will also be a contact point for any questions regarding the study. If you do not consent to participate, you will not be disadvantaged because of this. After obtaining consent for the study, participants will be asked to complete an application questionnaire on a subsequent webpage concerning items related to vegetable preferences and the selection criteria for the test to measure skin carotenoid concentrations, as well as the possible test dates for participation. A target of 550 research subjects will be selected who meet the selection criteria and who have been judged by Kagome and DLS (business unit) to have no problems participating in the study. The research subjects will be notified by email from the DLS (business unit) and invited to visit the study site. Those who are not selected as research subjects will also be informed by the DLS (business unit), at which point their participation in the study will be terminated. Study subjects will have their skin carotenoid levels measured at the study site using Vegicheck. Study subjects will also be notified in advance by email about the web-based Food Frequency of Intake Survey (FFQ NEXT detailed version) provided by Kenpakusha Co Ltd (hereafter referred to as Kenpakusha) on its servers and asked to respond to the survey. If responses to the web-based FFQ cannot be confirmed by the day of the visit, participants may be asked to respond at the site on the day of the study. Research subjects who have participated in the study to the end will be sent an acknowledgement Amazon gift certificate worth 5,000 yen by email from the DLS (Business Unit) at a later date.
Adverse events
NA
Outcome measures
Skin carotenoid levels
Vegetable preferences
Food intake
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Among the members of "MYCODE," a genetic testing service conducted by the DeNA Life Science, Inc., participants who have agreed to participate in a comprehensive study will be invited to participate in this study through web and e-mail notifications. After obtaining informed consent for this study, participants will be asked to complete a questionnaire at the time of application regarding items related to vegetable preferences, selection criteria for this study to measure skin carotenoid concentrations, and available study dates for participation. Participants will be measured for their skin carotenoid levels measured at the study site. In addition, participants will be notified in advance through e-mail of a web-based version of the food frequency questionnaire (FFQ) and asked to complete it. Statistical analysis will be conducted by KAGOME CO., LTD. A search for genes associated with skin carotenoid concentration, vegetable preference, and vegetable consumption will be conducted using characteristics information such as age and gender, questionnaire data at the time of application, skin carotenoid concentration data, FFQ data obtained in this study, and SNPs data already obtained in the MYCODE study.
Management information
Registered date
| 2022 | Year | 09 | Month | 22 | Day |
Last modified on
| 2024 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055803
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
