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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000022385
Receipt No. R000025797
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
Date of disclosure of the study information 2017/12/30
Last modified on 2017/09/15

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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)17 to 20 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
2017 Year 09 Month 15 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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