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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000024544
Receipt No. R000028248
Scientific Title Effects of milk product intake on improvements of QOL and physical fitness in elderly people
Date of disclosure of the study information 2016/10/24
Last modified on 2016/10/24

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Basic information
Public title Effects of milk product intake on improvements of QOL and physical fitness in elderly people
Acronym Effects of milk product intake in elderly people
Scientific Title Effects of milk product intake on improvements of QOL and physical fitness in elderly people
Scientific Title:Acronym Effects of milk product intake in elderly people
Region
Japan

Condition
Condition Age-associated diseases
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To examine the effects of exercise training + milk product intake on the improvements of physical fitness, glucose tolerance, body temperature regulation, and the symptons of lifstyle-related diseases together with the epigenetic effects of inflammatory genes in elderly people.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes physical fitness, glucose tolerance, body temperature regulation, the symptons of lifestyle-related diseases, and the methylation of inflammatory genes
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Interval walking training + no milk product intake. Subjects perform interval walking training; repeating more than 5 sets of fast walking, equivalent to more than 70% of peak aerobic capacity, and slow walking, equivalent to ~40% peak aerobic capacity, for 3 min each per day, for more than 4 days/week, for 5 months.
Interventions/Control_2 Interval walking training + low dose of milk product intake. Subjects consume milk product containing 4.1g milk protein immediately after interval walking training.
Interventions/Control_3 Interval walking training + high dose of milk product intake. Subjects consume milk product containing 12.3g milk protein immediately after interval walking training.
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
50 years-old <=
Age-upper limit
75 years-old >=
Gender Female
Key inclusion criteria 1) Middle-aged older women who have performed interval walking training more than 6 month.
2) Those whose sustolic/diastolic blood pressures are less than 159/99 mmHg
3) Those who have no difficalty in performing interval walking training
4) Those who attend the study as subjects voluntarily.
Key exclusion criteria 1) Those who have habit of smoking
2) Those whom the chie investigator judged as inappropriate to participate in the study for some reasons.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Nose
Organization Shinshu University Garduate School of Medicine
Division name DEpartment of Sports Medical Sciences
Zip code
Address 3-1-1 Asahi Matsumoto 390-8621
TEL 0263-37-2681
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 Department of Sports Medical Sciences
Zip code
Address 3-1-1 Asahi Matsumoto 390-8621
TEL 0263-37-2681
Homepage URL
Email nosehir@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 10 Month 24 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
2012 Year 01 Month 20 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 20 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 10 Month 24 Day
Last modified on
2016 Year 10 Month 24 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028248

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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