UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	To compare effectiveness of taking amino acids in the morning with that in the evening (chrono-nutrition and amino acids.
Title of the study (Brief title)	To compare effectiveness of taking amino acids in the morning with that in the evening (chrono-nutrition and amino acids.
Region	Japan

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

Objectives
Narrative objectives1	To compare effectiveness of taking amino acids in the morning with that in the evening
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Muscle mass of whole body on Days 0, 14, and 28 after initiation of administration and on Day 14 after completion.
Key secondary outcomes	Body weight, amount of body fat, amount of skin moisture, and amount of moisture loss via the skin on Days 0, 14, and 28 after initiation of administration and on Day 14 after completion. Amount of salivary hormone, skin viscous elasticity, and QOL questionnaire.

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

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Taking an amino-acid supplement at the time of awakening and a placebo before bed time is continued for 4 weeks.
Interventions/Control_2	Taking a placebo at the time of awakening and an amino-acid supplement before bed time is continued for 4 weeks.
Interventions/Control_3	Taking a placebo at the time of awakening and before bed time is continued for 4 weeks.
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 consent 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 an officer.
Target sample size	30

Research contact person
Name of lead principal investigator	Motoko Takaoka
Organization	Kobe College
Division name	School of Human Sciences, Department of Biosphere Sciences
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	Taizo Seki
Organization	Noevir Co., Ltd.
Division name	Groupwide Research and Development
Address	112-1, Okada-cho, Higashiomi, Shiga
TEL	0748-35-2452
Homepage URL
Email	taizou_seki@n1.noevir.co.jp

Sponsor
Institute	Kobe College
Institute
Department

Funding Source
Organization	Noevir Co., Ltd. DAC Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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

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） Kobe College（Hyogo Prefecture）

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 07 Day
Anticipated trial start date	2016 Year 10 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 10 Month 13 Day
Last modified on	2018 Year 04 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028073