UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000055501 |
|---|---|
| Receipt number | R000063416 |
| Scientific Title | Further analysis of protein absorption after ingesting an enteral diet |
| Date of disclosure of the study information | 2026/09/01 |
| Last modified on | 2024/09/13 17:40:21 |
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Basic information
Public title
Further analysis of protein absorption after ingesting an enteral diet
Acronym
Further analysis of protein absorption after ingesting an enteral diet
Scientific Title
Further analysis of protein absorption after ingesting an enteral diet
Scientific Title:Acronym
Further analysis of protein absorption after ingesting an enteral diet
Region
| Japan |
Condition
Condition
Healthy male adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This purpose of this study is further analysis of protein absorption after ingesting an enteral diet (UMIN00049118), to compare the amino acids metabolites .
Basic objectives2
Others
Basic objectives -Others
metabolite analysis
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concentration of amino acids metabolites in blood
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 35 | years-old | > |
Gender
Male
Key inclusion criteria
Subjects who joined post study (UMIN00049118) and give informed consent to participate in this further analysis.
Key exclusion criteria
No setting
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Kawai |
Organization
Meiji Co., Ltd.
Division name
Nutrition Development Research Unit, R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo , Japan
TEL
042-632-5810
yoshitaka.kawai@meiji.com
Public contact
Name of contact person
| 1st name | Kazuji |
| Middle name | |
| Last name | Tamura |
Organization
Meiji Co., Ltd
Division name
Nutrition Development Research Unit, R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo, Japan
TEL
042-632-5810
Homepage URL
kazuji.tamura@meiji.com
Sponsor or person
Institute
Meiji Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Meiji 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.co.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
| 2026 | Year | 09 | 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
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
Preinitiation
Date of protocol fixation
| 2024 | Year | 08 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Compare the amino acids metabolites
Management information
Registered date
| 2024 | Year | 09 | Month | 13 | Day |
Last modified on
| 2024 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063416
