UMIN-CTR Clinical Trial

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	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	28
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	Completed
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 09 Month 28 Day

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