UMIN-CTR Clinical Trial

Basic information
Public title	The effect of exercise and L-citrulline and L-leucine supplementation on vital function in elderly sarcopenic people.:Placebo-controlled, double-blind, parallel design trial
Acronym	The effect of amino acids on vital function.
Scientific Title	The effect of exercise and L-citrulline and L-leucine supplementation on vital function in elderly sarcopenic people.:Placebo-controlled, double-blind, parallel design trial
Scientific Title:Acronym	The effect of amino acids on vital function.
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study is to investigate the effect of exercise and L-citrulline and L-leucine supplementation on vital function in elderly sarcopenic people.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Physical strength(0,12,20 weeks)
Key secondary outcomes	questionnaire Blood analysis Cfpwv Five Cognitive Functions

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Light exercise and intake of placebo for 20 weeks.
Interventions/Control_2	Light exercise and intake of amino acids for 20 weeks.
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	Female
Key inclusion criteria	(1)women from 65 to 80 years of age (2)16 to 21 of BMI (3)It is applicable to more than one item of physical ability in basic health check list for those over 65years old (4)Subject who usually doesn`t exercise (5)Subject who has exercise contraindication (6)Subject has given consent to participate in the study (7)Subject who gets motivated to this study (8)Subject has given consent to participate continuously once per 1week
Key exclusion criteria	(1)Subject is taking a neurological medicine (2) Subjects having a current or past history of serious diseases such as diabetes, hepatic or renal disorder, or cardiovascular disease (3)a drinking habit (4) Subjects having possibilities for emerging allergy related to the study (5)a smoking habit (6) Subjects who have done hematologic test within the last 10 weeks prior (7) Subjects who have participated in other clinical study within the last 10 weeks prior to the current study or are participating in other clinical study currently (8) Subjects judged as unsuitable for the study by the investigator for other reasons
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Okura Tomohiro
Organization	University of Tsukuba
Division name	Faculty of Health and sport science
Zip code
Address	1-1-1 Tennodai, Tsukuba
TEL	029-859-2733
Email	okura@taiiku.tsukuba.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yoon Jiyeong
Organization	University of Tsukuba
Division name	Faculty of Health and sport science
Zip code
Address	1-2 Kasuga, Tsukuba
TEL	029-859-1593
Homepage URL
Email	yoon.jiyeong.fw@u.tsukuba.ac.jp

Sponsor
Institute	Tsukuba University
Institute
Department

Funding Source
Organization	KYOWA HAKKO BIO CO., LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2017 Year 12 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date	2016 Year 06 Month 06 Day
Last follow-up date	2016 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 05 Month 20 Day
Last modified on	2021 Year 02 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025797