UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039285 |
|---|---|
| Receipt number | 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 | 2021/07/27 10:56:07 |
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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
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
miyachi@nibiohn.go.jp
Sponsor or person
Institute
Department of Physical Activity Research, National Institutes of Biomedical Innovation, Health and Nutrition
Institute
Department
Personal name
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
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
https://academic.oup.com/nutritionreviews/article/79/1/66/5936522
Publication of results
Partially published
Result
URL related to results and publications
https://academic.oup.com/nutritionreviews/article/79/1/66/5936522
Number of participants that the trial has enrolled
5402
Results
A total of 5402 study participants from 105 articles were included. In the multivariate spline model, the mean increase in lean body mass associated with an increase in protein intake of 0.12 g/kg of body weight per day was 0.39 kg (95%CI, 0.36-0.41) and 0.12 kg (95%CI, 0.116-0.14) below and above the total protein intake of 1.3 g/kg/d, respectively.
Results date posted
| 2019 | Year | 12 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 11 | Month | 03 | Day |
Baseline Characteristics
Not applicable because it is a literature study.
Participant flow
Not applicable because it is a literature study.
Adverse events
Not applicable because it is a literature study.
Outcome measures
Not applicable because it is a literature study.
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
| 2021 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044150
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