UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024912 |
|---|---|
| Receipt number | 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 11:23:02 |
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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
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
masuki@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028659
