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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name