UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000037583
Receipt No. 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 (Ver. 1)

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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
Email 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
Email safujita@fc.ritsumei.ac.jp

Sponsor
Institute Ritsumeikan University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042763