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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020650
Receipt No. R000023834
Scientific Title Effects of AMF-101, CU-101 on muscle function in older adults - a randomized controlled trial.
Date of disclosure of the study information 2016/01/20
Last modified on 2016/01/20

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Basic information
Public title Effects of AMF-101, CU-101 on muscle function in older adults - a randomized controlled trial.
Acronym Effects of AMF-101, CU-101 on muscle function in older adults - a randomized controlled trial.
Scientific Title Effects of AMF-101, CU-101 on muscle function in older adults - a randomized controlled trial.
Scientific Title:Acronym Effects of AMF-101, CU-101 on muscle function in older adults - a randomized controlled trial.
Region
Asia(except Japan)

Condition
Condition Community based participatory
Classification by specialty
Medicine in general Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of the this study was to determine that the effects of AMF-101 and CU-101 on muscle function in older adults.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improved body composition, muscle function, physical fitness
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Educational,Counseling,Training
Type of intervention
Medicine
Interventions/Control_1 2 time per week 30 min - AMF-101
Interventions/Control_2 2 time per week 30 min - CU-101
Interventions/Control_3 Control - no treatment
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
60 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria over 60 years old
gait speed 1.3m/s
BMI 18.5-30.0
Key exclusion criteria creatinine 1.2 mg/dl
AST or ALT 60 lU/L
Fasting glucose >125 mg/dL
Target sample size 57

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Myung-Jun Shin
Organization Pusan National University School of Medicine
Division name Department of Rehabilitation Medicine
Zip code
Address 179 Gudeok-Ro Seo-Gu, Busan 602-739, Korea
TEL 82-51-240-7485
Email drshinmj@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Jong-Hwan, Park
Organization Dong-A University
Division name Institute of Convergence Bio-Health
Zip code
Address 32, Daeshingongwon-Ro, Seo-Gu, Busan, 602-715
TEL +82-51-240-2763
Homepage URL
Email jpark@dau.ac.kr

Sponsor
Institute Foretek Microsystem Co., Ltd
Institute
Department

Funding Source
Organization Ministry of Trade, Industry and Energy.
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
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
2016 Year 01 Month 20 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
2015 Year 03 Month 23 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 01 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 01 Month 20 Day
Last modified on
2016 Year 01 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023834

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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