UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059693 |
|---|---|
| Receipt number | R000068229 |
| Scientific Title | A Pilot Study on the Relationship Between Protein Metabolism Indicators and Blood Components in Healthy Adult Males: An Open-Label, Single-Arm Trial |
| Date of disclosure of the study information | 2025/11/07 |
| Last modified on | 2025/11/07 13:31:40 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Pilot Study on the Relationship Between Protein Metabolism Indicators and Nutritional Status in Healthy Adult Males: An Open-Label, Single-Arm Trial
Acronym
A Pilot Study on the Relationship Between Protein Metabolism Indicators and Nutritional Status
Scientific Title
A Pilot Study on the Relationship Between Protein Metabolism Indicators and Blood Components in Healthy Adult Males: An Open-Label, Single-Arm Trial
Scientific Title:Acronym
A Pilot Study on the Relationship Between Protein Metabolism Indicators and Blood Components
Region
| Japan |
Condition
Condition
Healthy Adult Males
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the relationship between protein metabolism indicators and blood component concentrations.
Basic objectives2
Others
Basic objectives -Others
To explore the relationship between various indicators used to evaluate protein metabolism and participant background information, including blood component concentrations.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between protein metabolism indicators and blood component concentrations.
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
Intake of standardized meals
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
| 65 | years-old | > |
Gender
Male
Key inclusion criteria
1) Individuals who provided written informed consent to participate in this trial.
2) Healthy adult males aged 20 to 65 years.
3) Individuals who are able to follow the investigator's instructions and adhere to the scheduled intake of the 15N-Glycine and the standardized meals, blood sampling, urine collection, and maintenance of rest.
Key exclusion criteria
1) Individuals judged by the principal investigator to be ineligible for this trial based on the results of the preliminary medical examination.
2) Individuals who showed a high-sensitivity CRP level of >= 0.2 mg/dL or an albumin level of < 3.8 g/dL at the time of the preliminary medical examination.
3) Individuals with diseases of the gastrointestinal, cardiovascular, or endocrine systems, or with a history of such conditions, as well as those who regularly take medications for the treatment of these diseases, who are judged by the principal investigator to be ineligible for this trial.
4) Individuals with food allergies.
5) Individuals who have had 200 mL or more of whole blood collected within the past 4 weeks, or 400 mL or more within the past 12 weeks prior to the first blood sampling.
6) Individuals who are currently participating in another trial or are scheduled to participate in another trial.
7) Individuals who are judged to be ineligible for this trial for other reasons by the principal investigator or the study director.
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Shoichiro |
| Middle name | |
| Last name | Inoue |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Advanced Research Institute for Core Science
Zip code
520-0106
Address
1-11-1 Karasaki, Otsu, Shiga
TEL
+81-77-519-0111
Inoue.Shoichiro@otsuka.jp
Public contact
Name of contact person
| 1st name | Shoichiro |
| Middle name | |
| Last name | Inoue |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Advanced Research Institute for Core Science
Zip code
520-0106
Address
1-11-1 Karasaki, Otsu, Shiga
TEL
+81-77-519-0111
Homepage URL
Inoue.Shoichiro@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical 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
The Ethics Committee of Otsuka Pharmaceutical Co., Ltd.
Address
Shinagawa Grand Central Tower, 2-16-4 Konan, Minato-ku, Tokyo 108-8242, Japan
Tel
+81-3-6717-1499
shimizu_se@otsuka.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 | 11 | Month | 07 | 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
| 2025 | Year | 11 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2025 | Year | 11 | Month | 07 | Day |
Last modified on
| 2025 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068229
