UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022385 |
|---|---|
| Receipt number | 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 | 2021/02/16 14:03:49 |
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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)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
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
yoon.jiyeong.fw@u.tsukuba.ac.jp
Sponsor or person
Institute
Tsukuba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025797
