UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025041 |
|---|---|
| Receipt number | R000028815 |
| Scientific Title | A clinical study on the relationship between plasma amino acid profile and improvement of lifestyle in the 20s and 30s for female. |
| Date of disclosure of the study information | 2016/11/30 |
| Last modified on | 2016/11/29 12:12:07 |
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Basic information
Public title
A clinical study on the relationship between plasma amino acid profile and improvement of lifestyle in the 20s and 30s for female.
Acronym
The effect of dietary and excise support program on the plasma free amino acid profile and body composition in young female.
Scientific Title
A clinical study on the relationship between plasma amino acid profile and improvement of lifestyle in the 20s and 30s for female.
Scientific Title:Acronym
The effect of dietary and excise support program on the plasma free amino acid profile and body composition in young female.
Region
| Japan |
Condition
Condition
Young female
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of dietary and excise support program on the plasma amino acid profile and body composition in young female.
Basic objectives2
Others
Basic objectives -Others
Relationship among the plasma amino acid profile, nutrition intake and body composition.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Plasma amino acid concentration
Key secondary outcomes
Body weight, blood glucose, lipids, female hormone, body fat, muscle mass, etc.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Dietary and excise support program
Interventions/Control_2
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
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
Subject who signed the informed consent to participate in the study
Key exclusion criteria
Subjects who are judged by the doctor as not eligible to this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junko Aburaya |
Organization
Koga ekimae clinic
Division name
Koga kenshin center
Zip code
Address
2-7-14 Takachihodori miyazaki-shi Miyazaki
TEL
0985-22-2112
junkoab@kgh.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junko Aburaya |
Organization
Koga ekimae clinic
Division name
Koga kenshin center
Zip code
Address
2-7-14 Takachihodori miyazaki-shi Miyazaki
TEL
0985-22-2112
Homepage URL
junkoab@kgh.or.jp
Sponsor or person
Institute
Ajinomoto Co., INC.
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto Co., INC.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Medical fitness fiore
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
古賀駅前クリニック（宮崎県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 30 | 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 | 02 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 23 | Day |
Date of closure to data entry
| 2016 | Year | 11 | Month | 22 | Day |
Date trial data considered complete
| 2016 | Year | 11 | Month | 24 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 29 | Day |
Last modified on
| 2016 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028815
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
