UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037199 |
|---|---|
| Receipt number | R000042163 |
| Scientific Title | A pilot study to assess skeletal muscle protein synthesis rate after protein supplementation |
| Date of disclosure of the study information | 2019/06/27 |
| Last modified on | 2021/07/05 10:07:14 |
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Basic information
Public title
A pilot study to assess skeletal muscle protein synthesis rate after protein supplementation
Acronym
A pilot study to assess skeletal muscle protein synthesis rate
Scientific Title
A pilot study to assess skeletal muscle protein synthesis rate after protein supplementation
Scientific Title:Acronym
A pilot study to assess skeletal muscle protein synthesis rate
Region
| Japan |
Condition
Condition
Normal healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A pilot study to assess skeletal muscle protein synthesis rate after protein supplementation
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
C-11 Methionine Influx rate constant Ki from plasma into skeletal muscle protein determined by graphical plotting analysis of C-11 methionine PET/CT imaging
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
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Food |
Interventions/Control_1
PET/CT after protein supplementation
Interventions/Control_2
PET/CT after water-intake
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
| 40 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy volunteers
1.Subjects with ability to make informed consent
2. Adult male who is from 20 years of age to 40 years old at the time of obtaining consent.
3. Adult male whose BMI is equal to or more than 18.5 kg/m2, and less than 25.0 kg/m2 at the time of study.
Key exclusion criteria
1.Subjects took agents (H2 blocker, PPI, digestive enzyme medicine), an unregulated drug (stomachic, digestant) which might have an influence on this study on the day of the study
2.Subjects with serious traumatic disorder or locomotor injury/ disease in the femoral region
3.Subjects with severe or chronic physical complications/disorders
4.Subjects who is considered to have diabetes, liver dysfunction, renal dysfunction, severe anemia, polycythemia, or diseases including infection, collagen disease, rheumatic fever, myocardial infarction, liver cirrhosis, sepsis, malignancy, viral disease, acute hepatitis, encephalitis, and endocrine disease by doctors with responsibilities in this study
5.Subjects with a milk allergy or lactose intolerance
6.Subjects with smoking habituation
7.Subjects who continue mild to intensive exercise habituation (i.e. 30 minutes a day, twice a week more than one year)
8.Subjects with claustrophobia
9.Subjects who participated in any other clinical trials for one month before this study
10.From the standpoint of radiation exposure from a nuclear medicine scan, subjects who received radiological examination such as X-rays, CT, PET, DEXA as clinical practice other than medical check-up in 12 months, or who have participated in other nuclear medicine scans as healthy volunteers in 6 months prior to the start of this study
11. Subjects who are considered to be inappropriate for participation by doctors with responsibilities in this study
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Ryuichi |
| Middle name | |
| Last name | Nishii |
Organization
National Institute of Radiological Sciences (NIRS), QST
Division name
Dept. of Molecular Imaging and Theranostics
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba
TEL
043-206-3429
nishii.ryuichi@qst.go.jp
Public contact
Name of contact person
| 1st name | Kazuko |
| Middle name | |
| Last name | Suzuki |
Organization
National Institute of Radiological Sciences (NIRS), QST
Division name
Clinical Reseach Support Section
Zip code
263-8555
Address
4-9-1 Anagawa, Inage-ku, Chiba
TEL
043-206-3025
Homepage URL
suzuki.kazuko@qst.go.jp
Sponsor or person
Institute
National Institute of Radiological Sciences (NIRS), QST
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
Meiji Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Certified Review Board, QST
Address
4-9-1 Anagawa, Inage-ku, Chiba
Tel
043-206-4706
helsinki@qst.go.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
量子科学技術研究開発機構 量子医学・医療部門 放射線医学総合研究所
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 06 | 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
Main results already published
Date of protocol fixation
| 2019 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2020 | 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
| 2019 | Year | 06 | Month | 27 | Day |
Last modified on
| 2021 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042163
