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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024386
Receipt No. R000028073
Scientific Title To compare effectiveness of taking amino acids in the morning with that in the evening (chrono-nutrition and amino acids.
Date of disclosure of the study information 2016/10/15
Last modified on 2018/04/15

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Basic information
Public title To compare effectiveness of taking amino acids in the morning with that in the evening (chrono-nutrition and amino acids.
Acronym To compare effectiveness of taking amino acids in the morning with that in the evening (chrono-nutrition and amino acids.
Scientific Title To compare effectiveness of taking amino acids in the morning with that in the evening (chrono-nutrition and amino acids.
Scientific Title:Acronym 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
1st name
Middle name
Last name Motoko Takaoka
Organization Kobe College
Division name School of Human Sciences, Department of Biosphere Sciences
Zip code
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
Middle name
Last name Taizo Seki
Organization Noevir Co., Ltd.
Division name Groupwide Research and Development
Zip code
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)

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 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

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 Completed
Date of protocol fixation
2016 Year 10 Month 07 Day
Date of IRB
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

Other
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

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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