UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042997 |
|---|---|
| Receipt number | R000049091 |
| Scientific Title | The effect of energy surplus combined with protein supplement on muscle protein synthesis rate. |
| Date of disclosure of the study information | 2021/01/13 |
| Last modified on | 2021/01/13 18:57:12 |
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Basic information
Public title
The effect of energy surplus combined with protein supplement on muscle protein synthesis rate.
Acronym
Energy surplus and muscle protein synthesis rate.
Scientific Title
The effect of energy surplus combined with protein supplement on muscle protein synthesis rate.
Scientific Title:Acronym
Energy surplus and muscle protein synthesis rate
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of energy surplus on muscle protein synthesis rate.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Myofibrillar protein synthesis rate.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
One week consumption of additional protein intake (energy requirement*0.1kcal) following weight maintenance standard meal consumption for 1 week.
Interventions/Control_2
One week consumption of additional protein and carbohydrate intake (energy requirement*0.1kcal and energy requirement*0.3kcal respectively) following weight maintenance standard meal consumption for 1 week.
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
| 45 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Individuals who understand the purpose and contents of the study, have ability to provide written consent, and give the written informed consent form
2) Healthy men whose age 20 to 45 years old
3) Who do not have exercise training more than 20 hours per week.
Key exclusion criteria
1) Who have severe or progressive disorder
2) Who have history of digestive surgery
3) Who have medical history in kidney
4) Diabetes, impaired glucose tolerance patients
5) Constant use of medicine which influence the metabolism
6) Who drink a lot of alcohol(60g/day)
7) Whose eating habits are extremely irregular
8) Who participate or are willing to participate clinical trials of other food products, drugs, or beauty products.
9) Who are allergic to milk.
10) Constant user of protein or amino acids supplements
11) Who are judged as unsuitable for the study by the principal investigator for other reasons
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Kawanaka |
Organization
Fukuoka University
Division name
Faculty of Sports and Health Science
Zip code
8140180
Address
8-19-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, 814-0180, Japan
TEL
0928716631(6720)
kawanaka@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Kawanaka |
Organization
Fukuoka University
Division name
Fukuoka University
Zip code
8140180
Address
8-19-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, 814-0180, Japan
TEL
0928716631(6720)
Homepage URL
http://www.fuipa.spo.fukuoka-u.ac.jp/
kawanaka@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
same as above
Address
8-19-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, 814-0180, Japan
Tel
0928716631
fumed-ethics@fukuoka-u.ac.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
福岡大学スポーツ科学部（福岡）
基盤研究機関身体活動研究所
Fukuoka University in Faculty of Sports and Health Science
Central Research Institute for Physical Activity
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 13 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2025 | 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
| 2021 | Year | 01 | Month | 13 | Day |
Last modified on
| 2021 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049091
