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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000012274
Receipt No. R000014355
Scientific Title The impact of milk intake during exercise training on health promotion in middle-aged and older people
Date of disclosure of the study information 2013/11/12
Last modified on 2013/12/12

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Basic information
Public title The impact of milk intake during exercise training on health promotion in middle-aged and older people
Acronym Combined effects of exercise and milk intake
Scientific Title The impact of milk intake during exercise training on health promotion in middle-aged and older people
Scientific Title:Acronym Combined effects of exercise and milk intake
Region
Japan

Condition
Condition life-style related diseases
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To test combined effects od exercise and milk intake.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Methylation of inflammatrory genes
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food Behavior,custom
Interventions/Control_1 Interval walking training
Interventions/Control_2 Milk intake
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
70 years-old >=
Gender Male
Key inclusion criteria 1) Those who had performed interval walking for 6 months but now do not.
2) Those who did not suffer any damage from interval walking training.
Key exclusion criteria 1) Those who did not have any intolerance to lactose or any allergy aginst milk.
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Nose
Organization Shinshu University, Graduate School of Medicine.
Division name Sports Medical Sciences
Zip code
Address 3-1-1 Asahi Matsumoto
TEL 0363-37-2681
Email nosehir@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Nose
Organization Shinshu University Graduate School of Medicine
Division name Sports Medical Sciences
Zip code
Address 3-1-1 Asahi Matsumoto
TEL 0263-37-2681
Homepage URL
Email nosehir@shinshu-u.ac.jp

Sponsor
Institute Shinshu University
Institute
Department

Funding Source
Organization MEXT(Japan)
Organization
Division
Category of Funding Organization
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
2013 Year 11 Month 12 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 Preinitiation
Date of protocol fixation
2013 Year 11 Month 05 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 15 Day
Last follow-up date
2019 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
2013 Year 11 Month 12 Day
Last modified on
2013 Year 12 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014355

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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