UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024386 |
|---|---|
| Receipt number | 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 09:55:53 |
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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
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
taizou_seki@n1.noevir.co.jp
Sponsor or person
Institute
Kobe College
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028073
