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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005728
Receipt No. R000006771
Scientific Title Association of Japanese-specific anxiety related traits with a polymorphism in the serotonin transporter gene in physical activity and sport: open-label, non-randomaized, single group assignment, time series designed trial.
Date of disclosure of the study information 2011/06/06
Last modified on 2019/06/12

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Basic information
Public title Association of Japanese-specific anxiety related traits with a polymorphism in the serotonin transporter gene in physical activity and sport: open-label, non-randomaized, single group assignment, time series designed trial.
Acronym Association of Japanese-specific anxiety related traits with a polymorphism in the serotonin transporter gene.
Scientific Title Association of Japanese-specific anxiety related traits with a polymorphism in the serotonin transporter gene in physical activity and sport: open-label, non-randomaized, single group assignment, time series designed trial.
Scientific Title:Acronym Association of Japanese-specific anxiety related traits with a polymorphism in the serotonin transporter gene.
Region
Japan

Condition
Condition Healthy general population in physical activity and sport.
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To investigate the effects of the serotonin transporter polymorphism associated with the stressful events under pressure and risk of depression in physical activity and sport.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 1)Polymorphism in the serotonin transporter gene
2)Other genetic polymorphisms involved in emotion (comprehensively research)
Key secondary outcomes 2)State and Trait Anxiety Inventory(STAI)
3)Profile of Mood scale(BRUMS)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Gene Behavior,custom
Interventions/Control_1 We research psychological questionnaires of participants at the normal exercise day and the stressful events under pressure day. After that, we investigated thier types of serotonin transporter gene.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Healthy population in physical activity and sport.
2) Adults over 20 years of age, when we gather the mucous membrane in the mouth for DNA.
Key exclusion criteria 1)Person without medical history such as bronchial asthma, diabetes, heart troubles, the thyreoid disease.
2)Person that it was stopped participation by a doctor.
Target sample size 45

Research contact person
Name of lead principal investigator
1st name Kanaka
Middle name
Last name Yatabe
Organization St. Marianna University School of Medicine
Division name Department of Sports Medicine
Zip code 216-8511
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan
TEL +81-44-977-8111
Email kanaka@marianna-u.ac.jp

Public contact
Name of contact person
1st name Kanaka
Middle name
Last name Yatabe
Organization St. Marianna University School of Medicine
Division name Department of Sports Medicine
Zip code 216-8511
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan
TEL +81-44-977-8111
Homepage URL
Email kanaka@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research from Ministry of Education, Culture, Sports, Science and Technology (MEXT) in Japan.
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization St. Marianna University School of Medicine
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki
Tel 0449778111
Email kanaka@marianna-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 聖マリアンナ医科大学スポーツ医学講座(神奈川県)

Other administrative information
Date of disclosure of the study information
2011 Year 06 Month 06 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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 Open public recruiting
Date of protocol fixation
2011 Year 04 Month 01 Day
Date of IRB
2011 Year 04 Month 28 Day
Anticipated trial start date
2011 Year 04 Month 28 Day
Last follow-up date
2030 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 06 Month 06 Day
Last modified on
2019 Year 06 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006771

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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