UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023358 |
|---|---|
| Receipt number | R000026871 |
| Scientific Title | A study of the effects of leucine intake in standing up training |
| Date of disclosure of the study information | 2016/07/31 |
| Last modified on | 2016/07/27 16:17:01 |
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Basic information
Public title
A study of the effects of leucine intake in standing up training
Acronym
A study of the effects of leucine intake in standing up training
Scientific Title
A study of the effects of leucine intake in standing up training
Scientific Title:Acronym
A study of the effects of leucine intake in standing up training
Region
| Japan |
Condition
Condition
rehabilitation patients
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to examine the effect of leucine intake in standing up training, which has main role in muscle protein synthesis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
changes of the muscle mass in 6 months
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
standing up training plus leucine intake
Interventions/Control_2
standing up traning alone
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
adult
Key exclusion criteria
over 1.1mg/dL in male, and over 0.7mg/dL in female for Cre
under 60 for eGFR
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Tada |
Organization
Shimonoseki Rehabilitation Hospital
Division name
rehabilitation
Zip code
Address
Imauracho 9-6, Shimonoseki, Yamaguchi, Japan
TEL
0832325811
Kmttada@aol.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Tada |
Organization
Shimonoseki Rehabilitation Hospital
Division name
rehabilitation
Zip code
Address
Imauracho 9-6, Shimonoseki, Yamaguchi, Japan
TEL
0832325811
Homepage URL
Kmttada@aol.com
Sponsor or person
Institute
Shimonoseki Rehabilitation Hospital
Institute
Department
Personal name
Funding Source
Organization
Shimonoseki Rehabilitation Hospital
Organization
Division
Category of Funding Organization
Other
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 | 07 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 27 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2017 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 27 | Day |
Last modified on
| 2016 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026871
