UMIN-CTR Clinical Trial

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