UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054129 |
|---|---|
| Receipt number | R000061551 |
| Scientific Title | Preliminary Clinical Trial on Leucine Requirement in Japanese Adult Men Using the Indicator Amino Acid Oxidation (IAAO) Method |
| Date of disclosure of the study information | 2024/04/12 |
| Last modified on | 2024/05/20 17:16:11 |
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Basic information
Public title
Preliminary Clinical Trial on Leucine Requirement in Japanese Adult Men Using the Indicator Amino Acid Oxidation (IAAO) Method
Acronym
Preliminary Clinical Trial on Leucine Requirement in Japanese Adult Men Using the Indicator Amino Acid Oxidation (IAAO) Method
Scientific Title
Preliminary Clinical Trial on Leucine Requirement in Japanese Adult Men Using the Indicator Amino Acid Oxidation (IAAO) Method
Scientific Title:Acronym
Preliminary Clinical Trial on Leucine Requirement in Japanese Adult Men Using the Indicator Amino Acid Oxidation (IAAO) Method
Region
| Japan |
Condition
Condition
Healthy adult male
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the procedures of the studies for evaluating L-leucine requirement by the International Council on Amino Acid Science (ICAAS)
Basic objectives2
Others
Basic objectives -Others
Amino acid requirement
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Expired rate of CO2 release
13CO2 enrichment in breath
13C phenylalanine enrichment in urine
Resting energy expenditure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consumption of the test food A
Interventions/Control_2
Consumption of the test food B
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
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
1. Japanese men aged 20 to below 60 years at the time of consent acquisition.
2. Subjects who have a habit of consuming three meals per day.
3. Subjects who can give informed consent to partake in this study, after being provided with an explanation of the protocol detail.
Key exclusion criteria
1. Subjects who are aware of a weight change of more than 5 kg in the month prior to obtaining consent.
2. Subjects with excessive alcohol intake.
3. Subjects suffering from diseases that affect protein and amino acid metabolism, such as diabetes, cancer, liver disease, kidney disease, HIV, etc.
4. Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs.
5. Subjects with allergies to medications and/or food.
6. Subjects who donated blood or component (200 mL) within the last 1 months.
7. Subjects who donated blood (400 mL) within the last 3 months.
8. Subjects who being collected in total of blood (1200 mL) within the last 12 months and in this study.
9. Subjects deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.
Target sample size
2
Research contact person
Name of lead principal investigator
| 1st name | Terutaka |
| Middle name | |
| Last name | Kodama |
Organization
The International Council on Amino Acid Science
Division name
Executive managing director
Zip code
100-0003
Address
c/o MAINICHI ACADEMIC FORUM, Inc. Palace side Building 1-1-1 Hitotsubashi, Chiyoda-ku Tokyo
TEL
03-6267-4550
secretariat01@e-icaas.org
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numa |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
The International Council on Amino Acid Science
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
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
| 2024 | Year | 04 | Month | 12 | 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
2
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 10 | 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 | 04 | Month | 12 | Day |
Last modified on
| 2024 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061551
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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