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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024912
Receipt No. R000028659
Scientific Title The combined efects of exercise and nutrititional supplements on prevention of life-style related diseases: studies to investigate epigenetic effects from DNA methylation in blood cells.
Date of disclosure of the study information 2016/11/20
Last modified on 2016/11/20

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Basic information
Public title The combined efects of exercise and nutrititional supplements on prevention of life-style related diseases: studies to investigate epigenetic effects from DNA methylation in blood cells.
Acronym Epigenetic effects by exercise and nutritional supplements
Scientific Title The combined efects of exercise and nutrititional supplements on prevention of life-style related diseases: studies to investigate epigenetic effects from DNA methylation in blood cells.
Scientific Title:Acronym Epigenetic effects by exercise and nutritional supplements
Region
Japan

Condition
Condition Pre-lifestyle related disease state
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To investigate the epigenetic effects by exercise and nutritional suppment intake.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Methylation of inflammatory genes
Key secondary outcomes physical fitness, lifestyle-related disease score (blood pressure, BMI, blood sugar concentratin, blood lipid concentrations)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Exercise + supplements for examination intake
An intervention period: several months
Frequency: 1-2 times/ day, 3-4 days/week
Dose: varies according to supplements
Interventions/Control_2 Exercise + placebo intake or no supplement intake
An intervention period: several months
Frequency: 1-2 times/ day, 3-4 days/week
Dose: varies according to supplements
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
40 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Middle-aged and older peple who will or have performed interval walking training.
Key exclusion criteria Middle-aged and older peple who will not or have not performed interval walking training.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shun-ichiro Taniguchi
Organization Shinshu University
Division name Graduate School of Medicine
Zip code
Address 3-1-1 Asahi Matsumoto
TEL 0263-37-2682
Email stangch@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shizue Masuki
Organization Shinshu University
Division name Graduate School of Medicine
Zip code
Address 3-1-1 Asahi Matsumoto
TEL 0263-37-2682
Homepage URL
Email masuki@shinshu-u.ac.jp

Sponsor
Institute Shinshu University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 20 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Completed
Date of protocol fixation
2011 Year 09 Month 06 Day
Date of IRB
Anticipated trial start date
2011 Year 09 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 19 Day
Last modified on
2016 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028659

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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