UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037583 |
|---|---|
| Receipt number | R000042763 |
| Scientific Title | Effects of lower protein intake at breakfast on muscle hypertrophy |
| Date of disclosure of the study information | 2019/08/05 |
| Last modified on | 2019/08/01 17:00:51 |
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Basic information
Public title
Effects of protein deficiency at breakfast on increase in muscle mass
Acronym
Breakfast intervention
Scientific Title
Effects of lower protein intake at breakfast on muscle hypertrophy
Scientific Title:Acronym
Breakfast intervention
Region
| Japan |
Condition
Condition
Sarcopenia
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to examine whether lower protein intake at breakfast affects muscle hypertrophy induced by resistance training
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To examine the efficacy of having enough protein at breakfast for muscle hypertrophy, we use Dual-energy X-ray Absorptiometry to compare percent change in fat free mass from baseline to week 12 between groups.
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
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Subjects have the provided meal and protein supplement at breakfast and perform resistance training 3 times/week.
Interventions/Control_2
Subjects have the provided meal at breakfast and protein supplement at dinner and perform resistance training 3 times/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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy individuals belong to Ritsumeikan University
Key exclusion criteria
Individuals who habitually skip breakfast, have serious disease, allergy to milk, egg, wheat, soy bean, pork, chicken, and gelatin.
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Fujita |
Organization
Ritsumeikan University
Division name
Faculty of Sport and Health Science
Zip code
525-8577
Address
1-1-1 Nojihigashi, Kusatsu, Shiga
TEL
077-561-5229
safujita@fc.ritsumei.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Fujita |
Organization
Ritsumeikan University
Division name
Faculty of Sport and Health Science
Zip code
525-8577
Address
1-1-1 Nojihigashi, Kusatsu, Shiga
TEL
077-561-5229
Homepage URL
safujita@fc.ritsumei.ac.jp
Sponsor or person
Institute
Ritsumeikan University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee for Human Experiments at Ritsumeikan University
Address
1-1-1 Nojihigashi, Kusatsu, Shiga
Tel
077-561-3412
b-rinri@st.ritsumei.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 05 | 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
33
Results
Percent changes in trunk and total fat free mass of Control 1 were greater than that of Control 2.
Results date posted
| 2019 | Year | 07 | Month | 27 | Day |
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
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 09 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 22 | 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 | 08 | Month | 02 | Day |
Last modified on
| 2019 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042763
