UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043794 |
|---|---|
| Receipt number | 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 | 2022/10/25 15:00:12 |
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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
The purpose of this study was to examine the 24-weeks follow-up of combined de-training effects after intervention of a leucine-enriched whey protein and resistance training on the skeletal muscle mass, strength, and sarcopenia status in older adults with sarcopenia using a randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of skeletal muscle mass index.
Baseline, end of intervention, at 12 weeks of de-training, at 24 weeks of de-training
Key secondary outcomes
remission of sarcopenia. Change of grip strength, knee extension strength, gait speed.
Baseline, end of intervention, at 12 weeks of de-training, at 24 weeks of de-training
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 adults with sarcopenia
Key exclusion criteria
Nutritional therapies for conditions such as type 2 diabetes and chronic kidney disease. Severe dementia, dysphagia, and joint disorders.
Resistance training has been conducted twice a week for the past year.
Non-sarcopenia.
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
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
mori.hiroyasu@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Japan Dairy Association
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
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
https://link.springer.com/article/10.1007/s12603-022-1853-1
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s12603-022-1853-1
Number of participants that the trial has enrolled
81
Results
Compared to baseline, ASMI and HGS increased significantly at the end of the intervention period in the RT+PRO group; however, there were no significant differences in change of ASMI and change of HGS between each group. At 24 weeks of the de-training period, change of ASMI and change of HGS were higher in the RT + PRO group than in the RT group.
Results date posted
| 2022 | Year | 10 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study included older adults aged >65 years who were screened for sarcopenia.
Participant flow
The participants were randomly allocated to one of three groups: whey protein supplementation after resistance training (RT + PRO; n = 27), resistance training only (RT; n = 27), and whey protein supplementation only (PRO; n = 27).
Adverse events
None
Outcome measures
Primary outcome is mean change of appendicular skeletal muscle mass index.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 2022 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049994
