UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exercise and nutrition intervention for the prevention of frailty in older adults: A randomized controlled trial
Title of the study (Brief title)	Exercise and nutrition intervention for the prevention of frailty
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine whether exercise and high protein and micro-nutrient supplementation more improve skeletal muscle mass and physical function than exercise alone in older adults.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Body composition Physical function
Key secondary outcomes	Physical activity Nutritional intake Blood biochemical value Weight Body mass index

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food Behavior,custom
Interventions/Control_1	Strength training and walking program
Interventions/Control_2	Strength training and walking program High protein and micro-nutrient supplementation
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	65 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Non-disabled person aged 65-80 years. 2) Person who can understand instruction.
Key exclusion criteria	1) Person who do moderate to vigorous physical activity more than 30 minutes, twice a week, and one year. 2) Person who deviate substantially from normal range of blood pressure and pulse. 3) Person who has irregular life style. 4) Person who has serious medical history, such as serious heart disease, kidney disease, liver disease, respiratory disease, or arthritis. 5) Person who deviate substantially from normal range of blood biochemical values. 6) Person who has food allergy or lactose intolerance. 7) Person who has restriction of protein intake. 8) Person who participated other clinical trial within 3-months. 9) Person who is judged inadequate for study subject.
Target sample size	80

Research contact person
Name of lead principal investigator	Shoji Shinkai
Organization	Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Division name	Tokyo Metropolitan Institute of Gerontology
Address	35-2 Sakae-cho, Itabashi-ku, Tokyo, Japan
TEL	03-3964-3241(4250)
Email	sshinkai@tmig.or.jp

Public contact
Name of contact person	Satoshi Seino
Organization	Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Division name	Tokyo Metropolitan Institute of Gerontology
Address	35-2 Sakae-cho, Itabashi-ku, Tokyo, Japan
TEL	03-3964-3241(4253)
Homepage URL
Email	seino@tmig.or.jp

Sponsor
Institute	Tokyo Metropolitan Institute of Gerontology
Institute
Department

Funding Source
Organization	Meiji CO., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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	2014 Year 10 Month 31 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 10 Month 01 Day
Anticipated trial start date	2014 Year 11 Month 01 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
Results
Other related information

Management information
Registered date	2014 Year 10 Month 28 Day
Last modified on	2017 Year 03 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018069