UMIN-CTR Clinical Trial

Basic information
Public title	The examination of the effect of wearing cloth with insulation function for muscle hypertrophy
Acronym	The examination of the effect of insulation function for muscle hypertrophy
Scientific Title	The examination of the effect of wearing cloth with insulation function for muscle hypertrophy
Scientific Title:Acronym	The examination of the effect of wearing cloth with insulation function for muscle hypertrophy
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effect of wearing cloth with insulation function for maintaining muscle temperature and muscle hypertrophy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Lower limb muscle thickness
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	Wearing cloth with insulation function
Interventions/Control_2	Wearing cloth without insulation function
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	20 years-old <=
Age-upper limit	40 years-old >=
Gender	Male
Key inclusion criteria	1) Healthy men whose age 20 to 40 years old with exercise habits(exercise more than walking above 30 minutes per week within three month past) 2) Individuals who understand the purpose and contents of the study, have ability to provide written consent, and give the written informed consent form
Key exclusion criteria	1) Who have severe or progressive disorder 2) Who have been banned exercise 3) Who have arrhythmia 4) Constant use of medicine 5) Who are judged as unsuitable for the study by the principal investigator for other reasons
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Yoshinari Middle name Last name Uehara
Organization	Fukuoka University
Division name	Faculty of Sports and Health Science
Zip code	814-0180
Address	8-19-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka
TEL	092-871-6631(6732)
Email	ueharay@fukuoka-u.ac.jp

Public contact
Name of contact person	1st name Shihoko Middle name Last name Nakashima
Organization	Fukuoka University
Division name	Faculty of Sports and Health Science
Zip code	814-0180
Address	8-19-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka
TEL	092-871-6631
Homepage URL
Email	shihoko@fukuoka-u.ac.jp

Sponsor
Institute	Fukuoka University
Institute
Department

Funding Source
Organization	Mizuno Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Fukuoka University Institutional Review Board
Address	8-19-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka
Tel	092-871-6631 (2813)
Email	suisin@adm.fukuoka-u.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	2022 Year 09 Month 20 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	18
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	2021 Year 06 Month 06 Day
Date of IRB	2021 Year 07 Month 16 Day
Anticipated trial start date	2021 Year 07 Month 01 Day
Last follow-up date	2021 Year 11 Month 16 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 09 Month 19 Day
Last modified on	2022 Year 09 Month 19 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053379