UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024952 |
|---|---|
| Receipt number | 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 15:28:15 |
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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
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
kido@kpu.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028709
| 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 |
