UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056477 |
|---|---|
| Receipt number | R000064540 |
| Scientific Title | The Effects of Regular Protein Intake and Squats on Body Temperature |
| Date of disclosure of the study information | 2024/12/17 |
| Last modified on | 2025/12/17 17:29:43 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The Effects of Protein Intake and Squats on Body Temperature
Acronym
The Effects of Protein and Squats on Body Temperature
Scientific Title
The Effects of Regular Protein Intake and Squats on Body Temperature
Scientific Title:Acronym
The Effects of Protein Intake and Squats on Body Temperature
Region
| Japan |
Condition
Condition
Healthy Male Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of squats and protein intake during the squat period on body temperature, and to propose protein intake as a method of infection prevention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
body temperature
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
40 squats per day for 4 weeks and daily intake of 28g of protein.
Interventions/Control_2
40 squats per day for 4 weeks.
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
| 22 | years-old | >= |
Gender
Male
Key inclusion criteria
Men who are capable of demonstrating their free will with sufficient understanding and who do not have a regular exercise routine.
Key exclusion criteria
Individuals with dairy allergies,swallowing disorder,muscle or joint pain.
Female.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | KUBO |
| Middle name | |
| Last name | Takaaki |
Organization
Kumamoto Health Science University
Division name
Faculty of Health Sciences
Zip code
8615598
Address
325 Izumi-machi, kiyta-ku, kumamoto
TEL
096-275-2111
kubo@kumamoto-hsu.ac.jp
Public contact
Name of contact person
| 1st name | KUBO |
| Middle name | |
| Last name | Takaaki |
Organization
Kumamoto Health Science University
Division name
Faculty of Health Sciences
Zip code
8615598
Address
325 Izumi-machi, kiyta-ku, kumamoto
TEL
096-275-2111
Homepage URL
kubo@kumamoto-hsu.ac.jp
Sponsor or person
Institute
Kumamoto Health Science University
Institute
Department
Personal name
Funding Source
Organization
Kumamoto Health Science 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
LS Ethics Review Committee Secretariat
Address
325 Izumi-machi, kiyta-ku, kumamoto
Tel
096-275-2112
kikaku@kumamoto-hsu.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 | 12 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
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
| 2024 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 06 | 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
| 2024 | Year | 12 | Month | 17 | Day |
Last modified on
| 2025 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064540
