UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Metabolomic analysis for Frailty
Title of the study (Brief title)	Metabolome for Frailty
Region	Japan

Condition
Condition	Frailty
Classification by specialty	Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Metabolomic analysis for Frailty
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Finding on human blood metbolome
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Healthy, frailty and bed-ridden
Key exclusion criteria	The patient with renal or liver dysfunction The patinet who are not suitable for the study, judged by clinical doctors.
Target sample size	60

Research contact person
Name of lead principal investigator	Hiroshi Kondoh
Organization	Kyoto Univ. Hospital
Division name	Geriatric unit
Address	54 Kawahara-cho Shogoin Sakyo-ku, Kyoto City
TEL	075-751-3465
Email	hkondoh@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Hiroshi Kondoh
Organization	Kyoto Univ. Hospital
Division name	Geriatric unit
Address	54 Kawahara-cho Shogoin Sakyo-ku, Kyoto City
TEL	075-751-3465
Homepage URL
Email	hkondoh@kuhp.kyoto-u.ac.jp

Sponsor
Institute	JSPS
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
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 04 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 09 Month 06 Day
Anticipated trial start date	2016 Year 10 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	Unpublished
URL releasing results
Results
Other related information	Metabolic anaylsis and cognitive function, muscle strength, muscle volumne and others

Management information
Registered date	2016 Year 09 Month 12 Day
Last modified on	2016 Year 09 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027647