UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018587 |
|---|---|
| Receipt number | R000021444 |
| Scientific Title | The clinical study of the effect of peptide ingestion in addition to strength training on the muscle strength of middle-aged and elderly people. |
| Date of disclosure of the study information | 2015/08/07 |
| Last modified on | 2015/08/06 19:00:51 |
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Basic information
Public title
The clinical study of the effect of peptide ingestion in addition to strength training on the muscle strength of middle-aged and elderly people.
Acronym
The clinical study of the effect of peptide ingestion in addition to strength training on the muscle strength of middle-aged and elderly people.
Scientific Title
The clinical study of the effect of peptide ingestion in addition to strength training on the muscle strength of middle-aged and elderly people.
Scientific Title:Acronym
The clinical study of the effect of peptide ingestion in addition to strength training on the muscle strength of middle-aged and elderly people.
Region
| Japan |
Condition
Condition
sarcopenia
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of peptide ingestion in addition to strength training on the muscle strength and muscle mass of middle-aged and elderly people for whom the maintenance of muscle is important to prevent sarcopenia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
muscle mass
Key secondary outcomes
muscle strength, IGF-1, and IL-6
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
placebo food
Interventions/Control_2
test 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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Participants in Jukunen Taiikudaigaku Project in Matsumoto
2) Over 40 years old
Key exclusion criteria
1) Subjects who were subject to the restriction of exercise within 3 month.
2) Subjects who are subject to the restriction of protein ingestion due to kidney disorder etc.
3) Subjects who ingest foods fortified with protein, peptide or amino acid regularly.
4) Subjects who have milk allergy.
5) Subjects who have a history of sever disorders in liver, kidney, heart, lung, gastro-intestine, blood, endocrine system, or metabolic system etc.
6) Subject who are judged inappropriate to this study by the investigator.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Oh Tae-Woong |
Organization
Matsumoto University
Division name
Health Science
Zip code
Address
2095-1, Niimura, Matsumoto-shi, Nagano, JAPAN
TEL
0263-48-7351
ohtw-72@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Oh Tae-Woong |
Organization
Matsumoto University
Division name
Health Science
Zip code
Address
2095-1, Niimura, Matsumoto-shi, Nagano, JAPAN
TEL
0263-48-7351
Homepage URL
ohtw-72@umin.ac.jp
Sponsor or person
Institute
Matsumoto University
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry Co., Ltd.
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 07 | 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
| 2015 | Year | 07 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 08 | 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
| 2015 | Year | 08 | Month | 07 | Day |
Last modified on
| 2015 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021444
