UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033932 |
|---|---|
| Receipt number | R000038701 |
| Scientific Title | Effect of combination of milk derived component and exercise on neuromuscular function |
| Date of disclosure of the study information | 2018/09/01 |
| Last modified on | 2020/03/10 07:29:43 |
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Basic information
Public title
Effect of combination of milk derived component and exercise on neuromuscular function
Acronym
Milk derived component and neuromuscular function
Scientific Title
Effect of combination of milk derived component and exercise on neuromuscular function
Scientific Title:Acronym
Milk derived component and neuromuscular function
Region
| Japan |
Condition
Condition
Healthy older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify effect of combination of milk derived component and exercise on neuromuscular function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-Maximal strength of knee extensor
-Cross sectional area of quadriceps femoris
-Electromyography and motor unit activation pattern of quadriceps femoris in knee extensor
-Questionnaires
Key secondary outcomes
-Electromyography and motor unit activation pattern of quadriceps femoris in knee extensor
-Questionnaires
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Isometric knee extension training with active food
Interventions/Control_2
Isometric knee extension training with placebo food
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Who volunteered to this trial in response to a letter of recruitment from the lead principal investigator
Key exclusion criteria
Who restricted exercise by medical doctors, has milk allergy
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kohei Watanabe |
Organization
Chukyo University
Division name
School of International Liberal Studies
Zip code
Address
101-2 Yagotohonmachi, Showa-ku, Nagoya, Aichi
TEL
0528357941
wkohei@lets.chukyo-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | HIROAKI MIYOSHI |
Organization
Chukyo University
Division name
Research support office
Zip code
Address
101-2
TEL
0528357941
Homepage URL
kenkyurinri@mng.chukyo-u.ac.jp
Sponsor or person
Institute
Chukyo University
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
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
中京大学（愛知県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 01 | 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
| 2018 | Year | 08 | Month | 09 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 07 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 29 | Day |
Last modified on
| 2020 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038701
