臨床研究等提出・公開システム

Japanese

Date of registration	Sept. 04, 2014
Last modified on	July. 30, 2015
Trial ID	jRCT1090220194

Scientific Title	The effect of exercise and nutrition on sarcopenic obesity in community-dwelling elderly Japanese women (Exercise and nutrition for sarcopenic obesity)
Public Title	The effect of exercise and nutrition on sarcopenic obesity in community-dwelling elderly Japanese women

Contact for Scientific Queries	Investigator Name	Hunkyung Kim
	Investigator Organization	Tokyo Metropolitan Institute of Gerontology
	Address	35-2 Sakaecho Itabashi-ku Tokyo, Japan
	TEL	+81-3-3964-3241
	E-mail	kimhk@tmig.or.jp
Contact for Public Queries	Contact Name	Hunkyung Kim
	Contact Organization	Tokyo Metropolitan Institute of Gerontology
	Address	35-2 Sakaecho Itabashi-ku Tokyo, Japan
	TEL	+81-3-3964-3241
	E-mail	kimhk@tmig.or.jp

Recruitment Status	COMPLETED

Date of First Enrollment		July. 31, 2014
Planned Number of Subjects		300
Nature of Investigation		Interventional
Study Design	Description of Trial Design	Randomized controlled trial
	Type of Control
	Trial Blinding Schema	single blind
	Randomized	Yes
Trial Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	Community-dwelling elderly women with sarcopenic obesity
	Exclusion Criteria	Severe knee of back pain, severely impaired mobility (unable to walk without the assistance of another person), impaired cognition, unstable cardiac conditions
	Minimum Age	70age old over
	Maximum Age	No limit
	Sex of Participants	Female
Trial Indication(s)		Sarcopenic Obesity
Intervention(s)		Intervention type:BEHAVIOUR Name of intervention:Exercise+nutritional intervention ,Exercise intervention ,Nutritional intervention Dose form / Japanese Medical Device Nomenclature:OTHER,OTHER,OTHER Powder amino-acid, liquid tea catechin Route of administration / Site of application:NOT APPLICABLE,NOT APPLICABLE,ORAL Dose per administration:60,60,3 60,60,6 minutes,minutes,g Dosing frequency / Frequency of use:BIW,BIW,BID Two times per week,Two times per week,Amino-acid: twice per day. Tea catechin: one bottle per day Planned duration of intervention:3 months,3 months,3 months Intended dose regimen:Exercise: 60 minute classes 2 times a week, for 3 months Nutrition: Amino-acid - 3g twice a day (total 6g), every day, 3 months. Tea catechin - 350ml per day, every day, 3 months.,Exercise: 60 minute classes 2 times a week, for 3 months ,Amino-acid - 3g twice a day (total 6g), every day, 3 months. Tea catechin - 350ml per day, every day, 3 months. detailes of teratment arms:One bottle of tea catechin (350ml) contains 540mg of catechins,Combination of both resistance and aerobic exercise,One bottle of tea catechin (350ml) contains 540mg of catechins Comparative intervention name:Health education Dose form / Japanese Medical Device Nomenclature:OTHER Route of administration / Site of application:NOT APPLICABLE Dose per administration:60 60 minutes Dosing frequency / Frequency of use:OTHER, SPECIFY Once every two weeks Planned duration of intervention:3 months Intended dose regimen:Every two weeks for three months
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Body composition, physical function
Secondary Outcome(s)		blood components

Primary Sponsor	Hunkyung Kim
Secondary Sponsor

Sources of funding	Grant-in-Aid for Scientific Research (Ministry of Education, Culture, Sports, Science and Technology); Research Grant of the Ministry of Health and Welfare of Japan

Name of Ethics Committee	Ethics Committe of Tokyo Metropolitan Institute of Gerontology
Address
TEL
FAX
E-Mail
Ethics Committee Website
Committee Approval Number
Approved by Ethics Committee	Yes
Reason for Unapproval

Date of approved	May. 29, 2014

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Secondary Study ID	Nill Known
Issuer Name

Secondary Study ID	JMA-IIA00194
Issuer Name

Countrie(s) of Recruitment	Japan

History of Changes

No	Publication date
2	July. 30, 2015	(this page)	Changes
1	Sept. 04, 2014	Detail

List of change history