UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052432 |
|---|---|
| Receipt number | R000059327 |
| Scientific Title | Effects of energy surplus with 12 weeks resistance training on changes in body composition and muscle strength |
| Date of disclosure of the study information | 2023/10/10 |
| Last modified on | 2023/10/06 11:05:04 |
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Basic information
Public title
Effects of energy surplus with 12 weeks resistance training on changes in body composition and muscle strength
Acronym
Effects of energy surplus with 12 weeks resistance training on changes in body composition and muscle strength
Scientific Title
Effects of energy surplus with 12 weeks resistance training on changes in body composition and muscle strength
Scientific Title:Acronym
Effects of energy surplus with 12 weeks resistance training on changes in body composition and muscle strength
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Revealing the effects of energy surplus with 12 weeks resistance training on changes in body composition and muscle strength
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body composition from baseline to after 12 weeks of resistance training
Key secondary outcomes
muscle strength
physical activity level
dietary survey
bioelectrical properties
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
| Other |
Interventions/Control_1
Subjects perform resistance training and consume moderate-energy snacks and drinks for 12 weeks.
Interventions/Control_2
Subjects perform resistance training and consume high-energy snacks and drinks for 12 weeks.
Interventions/Control_3
Subjects perform resistance training for 12 weeks without dietary manipulation.
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
| 18 | years-old | <= |
Age-upper limit
| 22 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Individuals who are adults at the time of consent acquisition.
2. Individuals who do not have any specific medical conditions and can be deemed healthy.
3. Individuals who have not engaged in resistance training for more than 6 months.
4. Individuals who, after receiving adequate explanation regarding participation in this study and with full comprehension, have provided written consent voluntarily.
Key exclusion criteria
1. Individuals who have been advised by a physician to refrain from physical activity due to injuries or other medical conditions.
2. Individuals currently participating in other trials during the study period or those who express an intention to participate.
3. Individuals who regularly use medications or supplements that could potentially affect the study.
4. Individuals deemed unsuitable as study participants by the principal investigator.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Shiose |
Organization
University of Miyazaki
Division name
Faculty of Education
Zip code
889-2192
Address
1-1 Gakuen Kibanadai-nishi, Miyazaki
TEL
0985-58-7111
kshiose@cc.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Shiose |
Organization
University of Miyazaki
Division name
Faculty of Education
Zip code
889-2192
Address
1-1 Gakuenkibanadai-nishi, Miyazaki
TEL
0985-58-7111
Homepage URL
kshiose@cc.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Keisuke Shiose
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Institute of Fitness and Sports in KANOYA
Name of secondary funder(s)
Meiji Co., Ltd.
IRB Contact (For public release)
Organization
The Faculty of Education Research Ethics Committee in University of Miyazaki
Address
1-1 Gakuenkibanadai-nishi, Miyazaki
Tel
0985-58-7773
edusoumu@of.miyazaki-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2023-12-E-829
Org. issuing International ID_1
The Faculty of Education Research Ethics Committee in University of Miyazaki
Study ID_2
23-1-33
Org. issuing International ID_2
The ethics committee of the National Institute of Fitness and Sports in Kanoya
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 10 | 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
| 2023 | Year | 07 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2028 | 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
| 2023 | Year | 10 | Month | 06 | Day |
Last modified on
| 2023 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059327
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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