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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018972
Receipt No. R000021948
Scientific Title Development of an exercise program to improve the drinking effect of fortified milk: focusing on the muscle mass and muscle strength in older adults
Date of disclosure of the study information 2015/09/10
Last modified on 2016/03/13

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Basic information
Public title Development of an exercise program to improve the drinking effect of fortified milk: focusing on the muscle mass and muscle strength in older adults
Acronym Development of an exercise and nutritional program to improve muscle function in older adults
Scientific Title Development of an exercise program to improve the drinking effect of fortified milk: focusing on the muscle mass and muscle strength in older adults
Scientific Title:Acronym Development of an exercise and nutritional program to improve muscle function in older adults
Region
Japan

Condition
Condition Decrease muscle mass and decline muscle strength
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To develop an exercise program to improve drinking effect of fortified milk on muscle mass and muscle strength
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Muscle mass
Key secondary outcomes 1. Muscle strength
2. Physical performance
3. VO2 peak
4. Nutritional status
5. Biochemical blood test
6. Arterial compliance

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Food Other
Interventions/Control_1 3-month intervention
1. Resistance training and aerobic training for twice per week.
2. Drinking fortified milk (200 ml) in everyday
Interventions/Control_2 3-month intervention
1. Resistance training for twice per week.
2. Drinking fortified milk (200 ml) in everyday
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
65 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1. Not restricted by a doctor from exercising
2. Not doing moderate-vigorous-intensity resistance training and aerobic training
3. Not participate in another clinical trial in one year
4. Not have lactose intolerance
5. Can agree with contents of study
6. Not take medication of diabetes

Key exclusion criteria 1. Care-dependent or support-dependent on a Japanese long-term care insurance system
2. Have severe heart disease, cerebrovascular disease, and renal dysfunction
3. Medical doctor can not agree with participation in study
4. Have too much habitual-milk intake
5. Feel knee pain in ecercise
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyoji Tanaka
Organization University of Tsukuba
Division name Faculty of Health and Sport Sciences
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8577, Japan
TEL +81-29-853-5600(8365)
Email tanaka@taiiku.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Jung Songee
Organization University of Tsukuba
Division name Faculty of Health and Sport Sciences
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8577, Japan
TEL +81-29-853-5600(8365)
Homepage URL
Email songeejung@hotmail.com

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization J-milk (Japan Dairy Association)
Organization
Division
Category of Funding Organization Non profit foundation
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 筑波大学総合研究棟D

Other administrative information
Date of disclosure of the study information
2015 Year 09 Month 10 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
2015 Year 07 Month 02 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 21 Day
Last follow-up date
2015 Year 12 Month 04 Day
Date of closure to data entry
2016 Year 02 Month 29 Day
Date trial data considered complete
2016 Year 03 Month 25 Day
Date analysis concluded
2016 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 09 Month 10 Day
Last modified on
2016 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021948

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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