UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049099 |
|---|---|
| Receipt number | R000055933 |
| Scientific Title | Research on weight gain and energy metabolism in collegiate athletes |
| Date of disclosure of the study information | 2022/10/07 |
| Last modified on | 2023/10/04 10:52:16 |
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Basic information
Public title
Research on weight gain and energy metabolism in collegiate athletes
Acronym
Research on weight gain and energy metabolism in athletes
Scientific Title
Research on weight gain and energy metabolism in collegiate athletes
Scientific Title:Acronym
Research on weight gain and energy metabolism in athletes
Region
| Japan |
Condition
Condition
Healthy individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the change in energy metabolism with weight gain in collegiate athletes
Basic objectives2
Others
Basic objectives -Others
Observation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Resting energy expenditure
Diet-induced thermogenesis
Key secondary outcomes
Body composition
Organ mass
Energy intake
Energy expenditure
Blood parameters
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Provide meals so that total energy intake is 500-1,000 kcal/day higher than energy intake for weight maintenance.
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
| 25 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Male athletes who are aged 18-25 years old
2. Participants who wish to gain their body weight
3. Participants who obtained consent to the study
Key exclusion criteria
1. Participants who take medicines of metabolism and hormone
2. Participants who are smokers
3. Participants who are judges inappropriate by a physician
4. Participants who refrain from daily training due to injury or illness
5. Participants with electrically, magnetically, or mechanically activated implants in the body
6. Participants who have food allergies and are unable to consume the provided meals
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Motoko |
| Middle name | |
| Last name | Taguchi |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15, Mikajima, Tokorozawa, Saitama, Japan
TEL
04-2947-6778
mtaguchi@waseda.jp
Public contact
Name of contact person
| 1st name | Motoko |
| Middle name | |
| Last name | Taguchi |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15, Mikajima, Tokorozawa, Saitama, Japan
TEL
04-2947-6778
Homepage URL
mtaguchi@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Waseda University
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
Ethics Review Committee on Research with Human Subjects, Waseda University
Address
1-104, Totsuka-cho, Shinjuku-ku, Tokyo
Tel
03-5272-1639
rinri@list.waseda.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
| 2022 | Year | 10 | Month | 07 | 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
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 09 | Day |
Last follow-up date
| 2024 | 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
| 2022 | Year | 10 | Month | 03 | Day |
Last modified on
| 2023 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055933
