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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024952
Receipt No. R000028709
Scientific Title Dietary protein quality evaluation by indicator amino acid oxidation technique
Date of disclosure of the study information 2016/11/22
Last modified on 2019/02/05

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Basic information
Public title Dietary protein quality evaluation by indicator amino acid oxidation technique
Acronym Dietary protein quality evaluation
Scientific Title Dietary protein quality evaluation by indicator amino acid oxidation technique
Scientific Title:Acronym Dietary protein quality evaluation
Region
Japan

Condition
Condition Healthy males
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate two types of dietary milk protein requirement of adult men
Basic objectives2 Others
Basic objectives -Others To evaluate two types of dietary milk protein requirement of adult men
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Concentration of carbon dioxide in expired gas
Key secondary outcomes

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
Food
Interventions/Control_1 Adult men ingest milk protein in the range of 0.5~1.4 g/kg BW/day
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

Not applicable
Gender Male
Key inclusion criteria Healthy male
Aged 20 or older
Key exclusion criteria Subjects with milk-allergies
participation in another clinical study
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhiro Kido
Organization Kyoto Prefectural University
Division name Graduate School of Life and Environment Sciences
Zip code
Address 1-5, Hangi-cho, Shimogamo, Sakyo-ku, Kyoto
TEL 075-703-5402
Email kido@kpu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuhiro Kido
Organization Kyoto Prefectural University
Division name Graduate School of Life and Environment Sciences
Zip code
Address 1-5, Hangi-cho, Shimogamo, Sakyo-ku, Kyoto
TEL 075-703-5402
Homepage URL
Email kido@kpu.ac.jp

Sponsor
Institute Kyoto Prefectural University
Institute
Department

Funding Source
Organization Morinaga Milk Industry Co, Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 22 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 18 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 22 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 11 Month 22 Day
Last modified on
2019 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028709

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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