UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058726 |
|---|---|
| Receipt number | R000067150 |
| Scientific Title | The effect of supplemental (total protein) intake after a specialized exercise program on body composition in middle-aged and elderly people: a randomized, parallel-group controlled trial |
| Date of disclosure of the study information | 2025/08/15 |
| Last modified on | 2025/08/20 15:05:32 |
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Basic information
Public title
The effects of combined exercise and nutritional therapy on body composition in middle-aged and elderly people
Acronym
Effects of combined therapy on body composition in middle-aged and elderly people
Scientific Title
The effect of supplemental (total protein) intake after a specialized exercise program on body composition in middle-aged and elderly people: a randomized, parallel-group controlled trial
Scientific Title:Acronym
The effect of supplemental (total protein) intake after a specialized exercise program on body composition in middle-aged and elderly people
Region
| Japan |
Condition
Condition
Community-dwelling elderly people
Classification by specialty
| Geriatrics | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the possible effects of combined resistance exercise and total protein intake on muscle hypertrophy and physical performance in community-dwelling middle-aged and elderly people compared to resistance exercise alone.
Basic objectives2
Others
Basic objectives -Others
Feasibility
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body composition
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Exercise + nutritional therapy (supplement intake)
Interventions/Control_2
Only exercise
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
| 60 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Participants must be able to take the supplement daily (only once after exercise or dinner).
2. Participants must own a smartphone or tablet and have sufficient IT literacy to watch YouTube videos freely (regardless of location or time).
3. Participants must be able to watch approximately 15 minutes of YouTube videos per day for 24 weeks (a data plan or Wi-Fi connection is required).
Key exclusion criteria
1. Individuals who are unable to walk independently and whose activities of daily living have been restricted by a doctor
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Suzuki |
Organization
Jichi Medical University
Division name
Department of Internal Medicine, Division of Endocrinology and Metabolism
Zip code
3290498
Address
3311-1 Yakushiji, Shimotsuke City, Tochigi Prefecture
TEL
0285-58-7355
nyahagi-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Suzuki |
Organization
University of Tsukuba
Division name
Systems and Information Engineering
Zip code
3058573
Address
1-1-1 Amakubo, Tsukuba City, Ibaraki Prefecture
TEL
0298536181
Homepage URL
minaminagasaki2007@yahoo.co.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
university of tsukuba
Address
3311-1 Yakushiji, Shimotsuke City, Tochigi Prefecture, 329-0498
Tel
0285-58-7355
yasuhiro@ai.iit.tsukuba.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
| 2025 | Year | 08 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 07 | Day |
Last modified on
| 2025 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067150
