UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055434 |
|---|---|
| Receipt number | R000063347 |
| Scientific Title | Change of intra-body dynamics after taking amino acids for short-term |
| Date of disclosure of the study information | 2025/01/27 |
| Last modified on | 2025/02/28 13:15:41 |
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Basic information
Public title
Change of intra-body dynamics after taking amino acids for short-term
Acronym
Short-term dynamics of amino acids
Scientific Title
Change of intra-body dynamics after taking amino acids for short-term
Scientific Title:Acronym
Short-term dynamics of amino acids
Region
| Japan |
Condition
Condition
Patients at outpatient ward and healthy volunteer
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Determine the dynamics of amino acids after short-term intake.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood amino acid levels
Key secondary outcomes
Laboratory data
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Amino acids
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 and Female
Key inclusion criteria
Patients at outpatient ward and healthy volunteer
Key exclusion criteria
Patients without consent
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Mizui |
Organization
Osaka University
Division name
Department of Nephrology, Graduate School of Medicine
Zip code
5650871
Address
Yamadaoka 2-2, Suita, Osaka
TEL
06-6879-3857
mmizui@kid.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinsuke |
| Middle name | |
| Last name | Sakai |
Organization
Osaka University
Division name
Department of Nephrology
Zip code
5650871
Address
Yamadaoka 2-2, Suita, Osaka
TEL
06-6879-3857
Homepage URL
sakai@kid.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Self funded
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Hosptital, Department of Education and Research Support, Division of Research Support
Address
Yamadaoka 2-2
Tel
06-6210-8296
rinri@hp-crc.med.oska-u.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
| 2025 | Year | 01 | Month | 27 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 27 | Day |
Last follow-up date
| 2028 | 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
| 2024 | Year | 09 | Month | 05 | Day |
Last modified on
| 2025 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063347
