臨床研究等提出・公開システム

Japanese

Date of registration	Aug. 24, 2018
Last modified on	April. 06, 2020
Trial ID	jRCT1090220378

Scientific Title	The effect of exercise and amino-acid supplementation on muscle mass and strength in community-dwelling elderly Japanese women with low muscle mass (Exercise and nutrition for low muscle mass)
Public Title	The effect of exercise and essential amino-acid supplementation on muscle mass and strength in community-dwelling elderly Japanese women with low muscle mass

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

Recruitment Status	COMPLETED

Date of First Enrollment		Sept. 07, 2018
Planned Number of Subjects		140
Nature of Investigation		Interventional
Study Design	Description of Trial Design	Randomized controlled trial
	Type of Control
	Trial Blinding Schema	double blind
	Randomized	Yes
Trial Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	Community-dwelling elderly women with low muscle mass (M-1.5SD)
	Exclusion Criteria	1. Chronic disease: severe back and knee pain, heart disease, CKD, unstable cardiac conditions 2. Sarcopenia 3. Meat and fish: intake every day 4. BP: more than SBP180mmHg, and DBP 100mmHg
	Minimum Age	65age old over
	Maximum Age	95age old under
	Sex of Participants	Female
Trial Indication(s)		low muscle mass
Intervention(s)		Intervention type:BEHAVIOUR Name of intervention:Exercise and nutritional supplementation Dose form / Japanese Medical Device Nomenclature:OTHER Other Route of administration / Site of application:ORAL Dose per administration:3 3 g Dosing frequency / Frequency of use:QD One time per day Planned duration of intervention:3 months Intended dose regimen:Exercise: 60 minutes classes 1 time a week, for 3 months Nutrition: Amino-acid 3g one time a day, everyday, 3 months detailes of teratment arms:Supplementation of amino-acid 3g a day Comparative intervention name:Placebo Dose form / Japanese Medical Device Nomenclature:OTHER Other Route of administration / Site of application:ORAL Dose per administration:0 0 g Dosing frequency / Frequency of use:QD One time per day Planned duration of intervention:3 months Intended dose regimen:Exercise and supplementation of placebo 1 time a day
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Muscle mass, muscle strength
Secondary Outcome(s)		Walking speed, questionnaire items

Primary Sponsor	Hunkyung Kim
Secondary Sponsor	Ajinomoto Co. Inc.

Sources of funding	Ajinomoto Co. Inc.

Name of Ethics Committee	The Clinical Research Ethics Committee of Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Address
TEL	+81-3-3964-3241
FAX	+81-3-3579-4776
E-Mail	kimhk@tmig.or.jp
Ethics Committee Website	http://www.tmghig.jp
Committee Approval Number	K71
Approved by Ethics Committee	Yes
Reason for Unapproval	No

Date of approved	June. 18, 2018

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Secondary Study ID	JMA-IIA00378
Issuer Name

Countrie(s) of Recruitment	Japan

History of Changes

No	Publication date
2	April. 06, 2020	(this page)	Changes
1	Aug. 24, 2018	Detail

List of change history