UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017615 |
|---|---|
| Receipt number | R000020407 |
| Scientific Title | Effect of amino acid intake on physical condition and skin state |
| Date of disclosure of the study information | 2015/05/19 |
| Last modified on | 2018/04/08 06:08:51 |
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Basic information
Public title
Effect of amino acid intake on physical condition and skin state
Acronym
Effect of amino acid intake on physical condition and skin state
Scientific Title
Effect of amino acid intake on physical condition and skin state
Scientific Title:Acronym
Effect of amino acid intake on physical condition and skin state
Region
| Japan |
Condition
Condition
Healthy individual
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study to what extent amino acid intake affects the lipid metabolism and skin state, and to evaluate the usefulness of amino acids to a change in body condition, reduction in body lipid and improvements of the skin state.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
skin state
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Amino acid supplements are taken after dinner and before sleeping. This is to be continued for 6 weeks. After the end of several weeks, placebo is taken after dinner and prior to sleeping. This is continued for 6 weeks.
Interventions/Control_2
Placebo is taken after dinner and before sleeping. This is to be continued for 6 weeks. After the end of several weeks, amino acid supplements are taken after dinner and prior to sleeping. This is continued for 6 weeks.
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 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 a 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, Okadacho, Higashiohmi-shi, Shiga
TEL
0748-35-5452
Homepage URL
taizo_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
| 2015 | Year | 05 | Month | 19 | 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
| 2015 | Year | 05 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 21 | 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
| 2015 | Year | 05 | Month | 19 | Day |
Last modified on
| 2018 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020407
