UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of the Effect of Walking with the Test Product (Shoes) on Muscle Activity.
Title of the study (Brief title)	Investigation of the Effect of Walking with the Test Product (Shoes) on Muscle Activity.
Region	Japan

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

Objectives
Narrative objectives1	The objective of this study was to investigate the effect of walking test products (shoes) on muscle activity in healthy Japanese women aged 30 years or older and younger than 55 years.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Electromyography
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
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	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	2-minute use of the test product Wash out 2-minute use of the placebo product
Interventions/Control_2	2-minute use of the placebo product Wash out 2-minute use of the test product
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	30 years-old <=
Age-upper limit	55 years-old >
Gender	Female
Key inclusion criteria	1)Age: 30 years or older, less than 55 years of age 2)Gender: Japanese women 3)Foot Size: 22.5 cm to 23.5 cm
Key exclusion criteria	1)Persons currently receiving any medication or outpatient treatment 2)History of liver disease or serious renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, metabolic disease 3)Persons with a history of drug or food allergy 4)Persons with a history of injury or surgery affecting gait 5)Individuals with extreme predation 6)Extremely irregular lifestyle, such as eating or sleeping 7)Persons with sleep disorders 8)Persons with a current or past history of psychiatric disorders (e.g., depression) 9)Persons with a current or past history of alcoholism 10)Those who are currently participating in other clinical studies or have participated in other clinical studies within the past 3 months 11)Pregnant, lactating women, or women who wish to become pregnant during the study 12)Persons with irregular working hours, such as night shifts 13)Other subjects who are considered inappropriate for inclusion in the study by the investigator
Target sample size	6

Research contact person
Name of lead principal investigator	Ochitani Daisuke
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Address	Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	81-3-3431-1260
Email	ochitani@huma-c.co.jp

Public contact
Name of contact person	Ochitani Daisuke
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Address	Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	81-3-3431-1260
Homepage URL
Email	ochitani@huma-c.co.jp

Sponsor
Institute	HUMA R&D CORP
Institute
Department

Funding Source
Organization	ASICS Trading Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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	2018 Year 05 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 04 Month 13 Day
Anticipated trial start date	2018 Year 05 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 05 Month 08 Day
Last modified on	2018 Year 07 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037084