UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024544 |
|---|---|
| Receipt number | 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 17:48:08 |
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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
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
nosehir@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 | 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028248
