UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018972 |
|---|---|
| Receipt number | 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 11:19:12 |
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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)
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
songeejung@hotmail.com
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021948
