UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study on the effect of combining genetic test and plasma amino acid test on promoting health care actions.
Title of the study (Brief title)	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	Maiko Mori
Organization	Ajinomoto Co., INC.
Division name	Institute for Innovation
Address	1-1 Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa, Japan
TEL	044-210-5828
Email	maiko_mori@ajinomoto.com

Public contact
Name of contact person	Nahoko Shikata
Organization	Ajinomoto Co. INC.
Division name	Institute for Innovation
Address	1-1 Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa, Japan
TEL	044-210-5828
Homepage URL
Email	nahoko_shikata01@ajinomoto.com

Sponsor
Institute	Ajinomoto Co., INC.
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.pref.kanagawa.jp/docs/mv4/cnt/f536433/documents/880014.pdf
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025776