UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study to verify the effect of walking with a specially processed insole
Title of the study (Brief title)	Study to verify the effect of walking with a specially processed insole
Region	Japan

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

Objectives
Narrative objectives1	While walking is good, the muscle load is imposed on the sandy beach walking training image, stimulation of Growth hormone (GH) secretion promotion, effects such as lowering of Glucose and Triglyceride is to be brought about by special processing insole.We hope to promote the health of the people through walking, and aim for LOCOMO countermeasures.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Growth hormone before and after walking
Key secondary outcomes	Cortisol, Triglyceride, Glucose, Insulin before and after walking

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Wear the test item and conduct walking (30 minutes) about 3 METS (normal walking degree).
Interventions/Control_2	Wear a control item and perform walking (about 30 minutes) about 3 METS (normal walking degree).
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	25 years-old <=
Age-upper limit	40 years-old >=
Gender	Female
Key inclusion criteria	Individuals who belong to or are related to Kanazawa Urata Clinic and who do not conflict with exclusion criteria
Key exclusion criteria	[1]Individuals using medical products [2]Individuals with serious medical history / current medical history [3]Individuals with serious anemia [4]Individuals who are pregnant or are posslibly, or are lactating
Target sample size	12

Research contact person
Name of lead principal investigator	Yoshikazu Yonei
Organization	Faculty of Life and Medical Sciences,Doshisha University
Division name	Anti-Aging Medical Research Center
Address	1-3 Tatara Miyakodani,Kyotanabe City,Kyoto
TEL	0774-65-6394
Email	yyonei@mail.doshisha.ac.jp

Public contact
Name of contact person	Seigo Isozaki
Organization	Faculty of Life and Medical Sciences,Doshisha University
Division name	Anti-Aging Medical Research Center
Address	1-3 Tatara Miyakodani,Kyotanabe City,Kyoto
TEL	0774-65-6394
Homepage URL
Email	isozaki@yonei-labo.com

Sponsor
Institute	Doshisha University
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	金沢浦田クリニック（石川県）

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 01 Month 31 Day
Anticipated trial start date	2018 Year 02 Month 20 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	Published
URL releasing results	http://www.toukastress.jp/webj/article/2018/GS18-21.pdf
Results
Other related information

Management information
Registered date	2018 Year 02 Month 13 Day
Last modified on	2019 Year 01 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035629