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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039285
Receipt No. R000044150
Scientific Title Effects of protein intake on muscular mass and strength: systematic review and meta-analysis
Date of disclosure of the study information 2020/01/28
Last modified on 2020/01/28

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Basic information
Public title Effects of protein intake on muscular mass and strength: systematic review and meta-analysis
Acronym Protein intake and muscles
Scientific Title Effects of protein intake on muscular mass and strength: systematic review and meta-analysis
Scientific Title:Acronym Protein intake and muscles
Region
Japan

Condition
Condition none
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to clarify the effects of protein intake on muscle mass and strength by meta-analysis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes muscular mass
Key secondary outcomes muscular strength, adipose tissue mass, body composition

Base
Study type Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
100 years-old >
Gender Male and Female
Key inclusion criteria Adult men and women who are healthy and independent
Key exclusion criteria Those who are not self-supporting or who have a serious diseases
Target sample size 5000

Research contact person
Name of lead principal investigator
1st name Motohiko
Middle name
Last name Miyachi
Organization National Institutes of Biomedical Innovation, Health and Nutrition
Division name Department of Physical Activity Research
Zip code 16208636
Address 1-23-1 Toyama, Sinjuku, Tokyo, Japan
TEL 0332038061
Email miyachi@nibiohn.go.jp

Public contact
Name of contact person
1st name Motohiko
Middle name
Last name Miyachi
Organization National Institutes of Biomedical Innovation, Health and Nutrition
Division name Department of Physical Activity Research
Zip code 1870011
Address 1-23-1 Toyama, Sinjuku, Tokyo, Japan
TEL 0332038061
Homepage URL
Email miyachi@nibiohn.go.jp

Sponsor
Institute Department of Physical Activity Research, National Institutes of Biomedical Innovation, Health and Nutrition
Institute
Department

Funding Source
Organization Department of Physical Activity Research, National Institutes of Biomedical Innovation, Health and Nutrition
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Meiji Holdings Co., Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Institutes of Biomedical Innovation, Health and Nutrition
Address 7-6-8 Asagi, saito, Ibaragi, Osaka, Japan
Tel 072-641-9811
Email irb-office@nibiohn.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

Other administrative information
Date of disclosure of the study information
2020 Year 01 Month 28 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 The purpose of this study was to conduct a meta-analysis using all relevant RCTs to confirm the dose-response relationship between daily amount of protein intake and increasing in muscle mass or lean body mass. The main finding of this study is that increasing the protein intake by 5 g / day significantly improves muscle mass, and the effect increases linearly at intakes higher than 50 g / day.
Results date posted
2019 Year 12 Month 20 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 Preinitiation
Date of protocol fixation
2018 Year 11 Month 29 Day
Date of IRB
Anticipated trial start date
2018 Year 12 Month 03 Day
Last follow-up date
2019 Year 11 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Background: Muscle mass is essential for health promotion and maintenance; however, consensus regarding the effectiveness of protein interventions in increasing muscle mass is still lacking.
Objective: To evaluate the dose-response relationship on the effects of protein on lean body mass (or fat-free mass).
Data Sources: PubMed and Ichushi-Web databases were searched, and a manual search of references from the selected literature of this study and included studies of other meta-analyses was conducted.
Study Selection: Randomized controlled trials evaluating the effect of supplementary protein intake on lean body mass which enabled group comparison were included.
Data Extraction: Two researchers independently screened the abstracts, and five researchers reviewed the full-texts.
Results: A total of 5411 subjects in 105 articles were included. Dose-response analysis using a multivariate-adjusted spline model showed that lean body mass significantly improved with about 5 g/day of supplementary protein intake; this effect further increased with supplementary protein intake of 50 g/day or more.
Conclusions: Increasing daily protein intake can help sustain and improve muscle mass in various populations irrespective of sex, age, and exercise habits.

Management information
Registered date
2020 Year 01 Month 28 Day
Last modified on
2020 Year 01 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044150

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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