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

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 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

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

Value
https://center6.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