UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054534 |
|---|---|
| Receipt number | R000062074 |
| Scientific Title | Measurements of Protein Turnover in Healthy Adult males. single-arm trail |
| Date of disclosure of the study information | 2024/05/31 |
| Last modified on | 2024/12/02 09:03:19 |
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Basic information
Public title
Measurements of Protein Turnover in Healthy Adult males. single-arm trail
Acronym
Measurements of Protein Turnover in Healthy Adult males. single-arm trail
Scientific Title
Measurements of Protein Turnover in Healthy Adult males. single-arm trail
Scientific Title:Acronym
Measurements of Protein Turnover in Healthy Adult males. single-arm trail
Region
| Japan |
Condition
Condition
Healthy Volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Measurements of protein turnover index in healthy adult males
Basic objectives2
Others
Basic objectives -Others
Research of relationship between protein turnover index and background information of volunteers
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
index of protein turnover
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 prescribed meals and load food
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
| 80 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Individuals who voluntarily give written informed consent.
2) Individuals who are healthy adult males aged 20-80.
3) Individuals who can participate in the intake of load food and prescribed meals, blood samplings, urine samplings, fecal samplings, keeping rest as scheduled.
4) Individuals who have smartphone which can install applications, and who agree with terms of service of wearable device and the applications.
Key exclusion criteria
1) Individuals who are judged to be ineligible for this study by the investigator based on the results of pre-screening diagnosis.
2) Individuals who are judged to be ineligible for this study by the investigator due to having a past or present medical history of gastrointestinal, cardiovascular, endocrine or other disorders and regularly using any medications for disease treatment.
3) Individuals who have difficulty with wearing wearable device.
4) Individuals who will stay overnight overseas between the test period and the post-observation period.
5) Individuals who have food allergies.
6) Individuals who donated blood within last 12 weeks prior to pre-screening diagnosis.
7) Individuals who are participating in other clinical studies or who are planning to participate in other clinical studies.
8) Individuals who are judged to be ineligible for this study with other concerns by the investigator, subinvestigator or study director.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yasutaka |
| Middle name | |
| Last name | Ikeda |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Otsu Nutraceuticals Research Institute
Zip code
520-0002
Address
3-31-13 Saigawa, Otsu, Shiga,
TEL
+81-77-521-8835
Ikeda.Yasutaka@otsuka.jp
Public contact
Name of contact person
| 1st name | Moe |
| Middle name | |
| Last name | Yamamoto |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Otsu Nutraceuticals Research Institute
Zip code
520-0002
Address
3-31-13 Saigawa, Otsu, Shiga,
TEL
+81-77-521-8835
Homepage URL
Yamamoto.Moe@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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
Tel
+81-3-6225-9005
IRB@cpcc.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
OTS24C2
Org. issuing International ID_1
CPCC Company Limited
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
チヨダパラメディカルケアクリニック(東京都)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 31 | 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
44
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
Completed
Date of protocol fixation
| 2024 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 29 | 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 | 05 | Month | 31 | Day |
Last modified on
| 2024 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062074
