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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000018587
Receipt No. 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

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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
Email 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
Email ohtw-72@umin.ac.jp

Sponsor
Institute Matsumoto University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021444

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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