UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035075 |
|---|---|
| Receipt number | R000039989 |
| Scientific Title | Total energy expenditure and body composition in athletes |
| Date of disclosure of the study information | 2018/11/30 |
| Last modified on | 2022/03/22 20:06:12 |
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Basic information
Public title
Total energy expenditure and body composition in athletes
Acronym
Total energy expenditure and body composition in athletes
Scientific Title
Total energy expenditure and body composition in athletes
Scientific Title:Acronym
Total energy expenditure and body composition in athletes
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate a total energy expenditure and body composition in athletes
Basic objectives2
Others
Basic objectives -Others
This study also evaluate to validity of doubly labeled water and body composition evaluation method
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
Total energy expenditure, fat mass, Fat free mass, %fat
Key secondary outcomes
Accuracy and precession of body composition measurement, Multi-component model, Water turn over
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The individuals who regularly exercise more than 4 days in a week as athletes
The individuals who unregularly exercise less than 2 days in a week as non-athletes
Key exclusion criteria
Metabolic disorders
Rehabilitant
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Sagayama |
Organization
University of Tsukuba
Division name
Faculty of Health and Sport Sciences
Zip code
305-8574
Address
1-1-1 Tennodai, Tsukuba, Ibaraki 3058574 Japan
TEL
029-853-3963
sagayama.h@gmail.com
Public contact
Name of contact person
| 1st name | Sagayama |
| Middle name | |
| Last name | Hiroyuki |
Organization
University of Tsukuba
Division name
Faculty of Health and Sport Sciences
Zip code
305-8574
Address
1-1-1 Tennodai, Tsukuba, Ibaraki 3058574 Japan
TEL
029-853-3963
Homepage URL
sagayama.h@gmail.com
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Japan Society For The Promotion Of Science
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba
Address
Faculty of Health and Sport Sciences
Tel
03-5963-0231
sagayama.h@gmail.com
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
福岡大学
国立スポーツ科学センター
筑波大学
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/sms.14017
Number of participants that the trial has enrolled
31
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 07 | Month | 06 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2018 | Year | 11 | Month | 30 | Day |
Last modified on
| 2022 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039989
