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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000043794
Receipt No. R000049994
Scientific Title Effects of resistance exercise and whey protein intake in the treatment of sarcopenia
Date of disclosure of the study information 2021/04/01
Last modified on 2021/03/31

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Basic information
Public title Effects of resistance exercise and whey protein intake in the treatment of sarcopenia
Acronym Treatment of sarcopenia, exercise, whey protein
Scientific Title Effects of resistance exercise and whey protein intake in the treatment of sarcopenia
Scientific Title:Acronym Treatment of sarcopenia, exercise, whey protein
Region
Japan

Condition
Condition sarcopenia
Classification by specialty
Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effectiveness of a 24-week nutritional supplementation program involving whey protein intake after resistance exercise in treatment of sarcopenia among older people with sarcopenia,
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes sarcopenia
Key secondary outcomes Skeletal muscle mass index, grip strength, gait speed, QOL

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food Behavior,custom
Interventions/Control_1 Resistance exercise and whey protein intake
Interventions/Control_2 Whey protein intake
Interventions/Control_3 Resistance exercise
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
65 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Older people with sarcopenia
Key exclusion criteria Patients with diabetes, chronic kidney disease, severe dementia, dysphagia, and joint disorders
Target sample size 81

Research contact person
Name of lead principal investigator
1st name Hiroyasu
Middle name
Last name Mori
Organization Tokushima University
Division name Institute of Advanced Medical Sciences
Zip code 7708503
Address 3-18-15, Kuramoto-cho, Tokushima, 770-8503
TEL 0886337587
Email mori.hiroyasu@tokushima-u.ac.jp

Public contact
Name of contact person
1st name Hiroyasu
Middle name
Last name Mori
Organization Tokushima University
Division name Institute of Advanced Medical Sciences
Zip code 7708503
Address 3-18-15, Kuramoto-cho, Tokushima, 770-8503
TEL 0886337587
Homepage URL
Email mori.hiroyasu@tokushima-u.ac.jp

Sponsor
Institute Tokushima University
Institute
Department

Funding Source
Organization J-Milk
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 University Hospital of Tokushima Clinica
Address 2-50-1, Kuramoto-cho, Tokushima
Tel 0886339294
Email awachiken@tokushima-u.ac.jp

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
2021 Year 04 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 81
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 No longer recruiting
Date of protocol fixation
2019 Year 04 Month 01 Day
Date of IRB
2019 Year 04 Month 22 Day
Anticipated trial start date
2019 Year 05 Month 01 Day
Last follow-up date
2021 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 03 Month 31 Day
Last modified on
2021 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049994

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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