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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025041
Receipt No. 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

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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
Email 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
Email junkoab@kgh.or.jp

Sponsor
Institute Ajinomoto Co., INC.
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028815

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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