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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034267
Receipt No. R000039053
Scientific Title Effect of intake of amino-acid supplement on the body compositions and muscle of young women
Date of disclosure of the study information 2018/09/30
Last modified on 2019/04/22

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Basic information
Public title Effect of intake of amino-acid supplement on the body compositions and muscle of young women
Acronym Effect of intake of amino-acid supplement on the body compositions and muscle of young women
Scientific Title Effect of intake of amino-acid supplement on the body compositions and muscle of young women
Scientific Title:Acronym Effect of intake of amino-acid supplement on the body compositions and muscle of young women
Region
Japan

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

Objectives
Narrative objectives1 Verification of amino-acid intake on the muscle-strengthening effect
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Body constituents:Body compositions (weight, body fat, water volume, muscle mass, etc.),Muscle test:Grip test, a one-leg stand test with closed eyes
6 measurement points:Weeks 0, 2, 4, 8, 10, and 15
Key secondary outcomes Visceral fat meter:Amount of visceral fat,abdominal circumference,Skin measurement:1Water volume,2TEWL,Questionnaire:Living habit, physical conditions, fatigue

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 NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Amino acid supplement(containing amino acids)
(Name of ingredient) L-leucine, L-glutamine, L-arginine, vitamins, excipients
Interventions/Control_2 Placebo control(not containing any amino acid)
(Name of ingredient) Vitamins, excipients
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
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1,The age at the time of obtaining a conesent is 20 years or older
2,Female
3,Those from whom a written consent can be obtained on a voluntary basis.
Key exclusion criteria The person who is unsuitable for the entry judged by a ficer
Target sample size 28

Research contact person
Name of lead principal investigator
1st name Motoko
Middle name
Last name Takaoka
Organization Kobe College
Division name School of Human Sciences, Department of Biosphere Sciences
Zip code 6628506
Address 4-1 Okadayama, Nhishinomiya-shi, Hyogo pref. 662-8506 Japan
TEL 0798-51-8668
Email takaoka@mail.kobe-c.ac.jp

Public contact
Name of contact person
1st name Saki
Middle name
Last name Okumura
Organization Noevir Co., Ltd.
Division name Groupwide Research and Development
Zip code 213-0012
Address R&D C Building No. 333, Kanagawa Science park (KSP), 3-2-1 Sakado, Takatsu-ku, Kawasaki-shi, Kanagaw
TEL 044-813-2488
Homepage URL
Email saki_okumura@n1.noevir.co.jp

Sponsor
Institute Kobe College
Institute
Department

Funding Source
Organization Noevir 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 KOBE college IRB
Address 4-1 Okadayama, Nhishinomiya-shi, Hyogo pref. 662-8506 Japan
Tel 0798-51-8553
Email jinjim@mail.kobe-c.ac.jp

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 神戸女学院大学(兵庫県)

Other administrative information
Date of disclosure of the study information
2018 Year 09 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
2018 Year 09 Month 14 Day
Date of IRB
2018 Year 09 Month 11 Day
Anticipated trial start date
2018 Year 10 Month 01 Day
Last follow-up date
2018 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
2018 Year 09 Month 26 Day
Last modified on
2019 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039053

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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