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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000037199
Receipt No. 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 2020/01/06

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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
Email 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
Email suzuki.kazuko@qst.go.jp

Sponsor
Institute National Institute of Radiological Sciences (NIRS), QST
Institute
Department

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
Email 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 Enrolling by invitation
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
2020 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042163

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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