UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022358 |
|---|---|
| Receipt number | R000025776 |
| Scientific Title | A study on the effect of combining genetic test and plasma amino acid test on promoting health care actions. |
| Date of disclosure of the study information | 2016/05/20 |
| Last modified on | 2018/05/23 15:32:09 |
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Basic information
Public title
A study on the effect of combining genetic test and plasma amino acid test on promoting health care actions.
Acronym
A study on the effect of combining genetic test and plasma amino acid test on promoting health care actions.
Scientific Title
A study on the effect of combining genetic test and plasma amino acid test on promoting health care actions.
Scientific Title:Acronym
A study on the effect of combining genetic test and plasma amino acid test on promoting health care actions.
Region
| Japan |
Condition
Condition
Metabolic syndrome and cancer
Classification by specialty
| Endocrinology and Metabolism | Hematology and clinical oncology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the hypothesis that combining genetic test and plasma amino acid test raises health consciousness and promotes taking health care actions.
Basic objectives2
Others
Basic objectives -Others
survey
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Analysis on the promoting effect of either single test or combination of genetic test and plasma amino acid test on taking health care actions by questionnaire survey before and 1 month after either test.
Key secondary outcomes
Analysis on the promoting effect of the results of genetic and plasma amino acid test on taking health care actions by questionnaire survey before and 1 month after either test.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Questionaire survey -> sampling of 5ml blood for amino acid measurement -> Questionnaire survey -> Sampling of saliva for SNP analysis -> Questionnaire survey
Interventions/Control_2
Questionnaire survey -> sampling of saliva for SNP analysis -> Questionnaire survey -> Sampling of 5ml blood for amino acid measurement -> Questionnaire survey
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
| 25 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Persons who have submitted written informed consent
Key exclusion criteria
1)Those who are pregnant, or breast feeding
2)Those who have congenital metabolic disorders
3)Those who are undergoing dialysis
4)Those who are participating in another clinical study
5)Those who have mental diseases or disorders and for whom doctors judged difficult to participate in the study.
6)Those for whom the doctor judged inappropriate to participate in the study.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Maiko Mori |
Organization
Ajinomoto Co., INC.
Division name
Institute for Innovation
Zip code
Address
1-1 Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa, Japan
TEL
044-210-5828
maiko_mori@ajinomoto.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nahoko Shikata |
Organization
Ajinomoto Co. INC.
Division name
Institute for Innovation
Zip code
Address
1-1 Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa, Japan
TEL
044-210-5828
Homepage URL
nahoko_shikata01@ajinomoto.com
Sponsor or person
Institute
Ajinomoto Co., INC.
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Ajinomoto Co., INC.
DeNA Life Science, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
神奈川県予防医学協会（神奈川県）
味の素株式会社（神奈川県）
株式会社DeNAライフサイエンス（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.pref.kanagawa.jp/docs/mv4/cnt/f536433/documents/880014.pdf
Number of participants that the trial has enrolled
Results
Combining the genetic testing "MYCODE" and "AminoIndexTM" screening test, based on plasma amino acid profile, raised health consciousness in mind and action compared to having either one of the tests.
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
| 2015 | Year | 10 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 19 | Day |
Last modified on
| 2018 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025776
