UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052568 |
|---|---|
| Receipt number | R000059963 |
| Scientific Title | Effect of timing of protein intake on the effect of muscle hypertrophy in humans |
| Date of disclosure of the study information | 2024/01/01 |
| Last modified on | 2023/10/19 22:13:27 |
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Basic information
Public title
Effect of timing of protein intake on the effect of muscle hypertrophy in humans
Acronym
Effect of timing of protein intake on the effect of muscle hypertrophy in humans
Scientific Title
Effect of timing of protein intake on the effect of muscle hypertrophy in humans
Scientific Title:Acronym
Effect of timing of protein intake on the effect of muscle hypertrophy in humans
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effect of different timing of protein intake on the effect of muscle hypertrophy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
muscle mass
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Consume a placebo in the morning for 4 weeks.
Interventions/Control_2
Consume a placebo in the evening for 4 weeks.
Interventions/Control_3
Consume a protein in the morning for 4 weeks.
Interventions/Control_4
Consume a protein in the evening for 4 weeks.
Interventions/Control_5
Consume a hot protein in the morning for 4 weeks.
Interventions/Control_6
Consume a hot protein in the evening for 4 weeks.
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
18 years-old <=, 50 years-old >=
Obtained written informed consent from the participant before participation
Key exclusion criteria
None
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Takahashi |
Organization
Tokyo Institute of Technology
Division name
Institute for Liberal Arts
Zip code
152-8550
Address
2-12-1, Ookayama Meguro, Tokyo
TEL
03-5734-2904
takahashi.m.bp@m.titech.ac.jp
Public contact
Name of contact person
| 1st name | Kyoko |
| Middle name | |
| Last name | Fujihira |
Organization
Tokyo Institute of Technology
Division name
Institute for Liberal Arts
Zip code
152-8550
Address
2-12-1, Ookayama Meguro, Tokyo
TEL
03-5734-2904
Homepage URL
fujihira.k.ac@m.titech.ac.jp
Sponsor or person
Institute
Tokyo Institute of Technology
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
Administrative office of Human Subjects Research Ethics Review Committee c/o: Research Safety Management Group, Research Planning Division, Research Promotion Department, Tokyo Institute of Technology
Address
2-12-1 Ookayama, Meguro, Tokyo
Tel
03-5734-3808
hitorinri@jim.titech.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
| 2024 | Year | 01 | Month | 01 | 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
60
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 12 | 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 | 21 | Day |
Last modified on
| 2023 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059963
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
