UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050212 |
|---|---|
| Receipt number | R000057152 |
| Scientific Title | Improvement of Indicator Amino Acid method to examine protein requirement |
| Date of disclosure of the study information | 2023/03/01 |
| Last modified on | 2025/02/03 16:31:25 |
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Basic information
Public title
Improvement of a method to examine protein requirement
Acronym
Estimation of protein requirement
Scientific Title
Improvement of Indicator Amino Acid method to examine protein requirement
Scientific Title:Acronym
Improvement of IAAO method
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The indicator amino acid method, which estimates human protein requirement, is less conducted in Japan. This study develops a test-meal and analysis method to conduct in Japan.
Basic objectives2
Others
Basic objectives -Others
Development of test-meal using foods that can be got in Japan, and make protocols to measure and analyze.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
13CO2 concentration in breath
Key secondary outcomes
urinary phenylalanine concentration
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Dose of test drink including crystalline amino acid mixture, protein-free cookies, oil blocks, [1-13C]phynylalanine, and NaH13CO3
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
Male and Female
Key inclusion criteria
healthy, not taking drugs and supplements regularly, non-smoker
Key exclusion criteria
having internal diseases, smoker
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kazuko |
| Middle name | |
| Last name | Ishikawa-Takata |
Organization
Tokyo University of Agriculture
Division name
Faculty of Appliled Bioscience
Zip code
1568502
Address
1-1-1 Sakuragaoka Setagaya tokyo, Japan
TEL
81-3-5477-2453
kt207460@nodai.ac.jp
Public contact
Name of contact person
| 1st name | Kazuko |
| Middle name | |
| Last name | Ishikawa-Takata |
Organization
Tokyo University of Agriculture
Division name
Faculty of Applied Bioscience
Zip code
1568502
Address
1-1-1 Sakuragaoka Setagaya Tokyo, Japan
TEL
81-3-5477-2453
Homepage URL
kt207460@nodai.ac.jp
Sponsor or person
Institute
Tokyo University of Agriculture
Institute
Department
Personal name
Kazuko Ishikawa-Takata
Funding Source
Organization
Tokyo University of Agriculture
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo University of Agriculture, The Ethical Committee of Experiment and Survey for Human
Address
1-1-1 Sakuragaoka Setagaya Tokyo, Japan
Tel
81-3-5477-2532
yyoshi@nodai.ac.jp
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
| 2023 | Year | 03 | Month | 01 | 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
12
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Took longer time to analyze samples than expected.
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 01 | Day |
Last modified on
| 2025 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057152
