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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044344
Receipt No. R000050607
Scientific Title Effectiveness of protein intake on resistance training-induced muscle growth among healthy adult population: a systematic review, meta-analysis, and meta-regression
Date of disclosure of the study information 2021/06/01
Last modified on 2021/05/27

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Basic information
Public title Effectiveness of protein intake on resistance training-induced muscle growth
Acronym Muscle growth and protein intake
Scientific Title Effectiveness of protein intake on resistance training-induced muscle growth among healthy adult population: a systematic review, meta-analysis, and meta-regression
Scientific Title:Acronym Muscle growth and protein intake: a systematic review
Region
Japan Europe

Condition
Condition None
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aim to evaluate effectiveness of protein intake on resistance training-induced muscle growth and determine potential heterogeneity.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Muscle mass indices (e.g. lean body mass, fat-free mass, lean soft tissue mass, skeletal muscle mass, muscle mass, and fat and bone-free mass)
Key secondary outcomes Muscle cross-sectional area (CSA) or muscle thickness (MT), and adverse events (e.g. dropouts or others related to compliance of participating in resistance training or supplementation program)

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
Key exclusion criteria Individuals who are with any medication affecting muscle mass regulation
Target sample size 3000

Research contact person
Name of lead principal investigator
1st name Jun
Middle name
Last name Yasuda
Organization Japan Sport Council
Division name Japan Institute of Sports Sciences
Zip code 115-0056
Address 3-15-1 Nishigaoka, Kita-ku, Tokyo
TEL 03-5963-0215
Email 55fhyanh@gmail.com

Public contact
Name of contact person
1st name Jun
Middle name
Last name Yasuda
Organization Japan Sport Council
Division name Japan Institute of Sports Sciences
Zip code 115-0056
Address 3-15-1 Nishigaoka, Kita-ku, Tokyo
TEL 03-5963-0215
Homepage URL
Email 55fhyanh@gmail.com

Sponsor
Institute Japan Institute of Sports Sciences, Japan Sport Council
Institute
Department

Funding Source
Organization Institute for Food and Health Science, Yazuya Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Japan Institute of Sports Sciences
Address 3-15-1 Nishigaoka, Kita-ku, Tokyo
Tel 03-5963-0215
Email 55fhyanh@gmail.com

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
2021 Year 06 Month 01 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 02 Month 20 Day
Date of IRB
Anticipated trial start date
2021 Year 02 Month 24 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Background: While protein intake is systematically well-reviewed as a key factor for the regulation of skeletal muscle mass (e.g. muscle hypertrophy or prevention of muscle loss with aging), there has been relatively high heterogeneity on the results of those reports (Morton et al. Br J Sports Med. 2018; Wirth et al. J Nutr. 2020; Tagawa et al. Nutr Rev. 2020).

Objective: we aim to evaluate effectiveness of protein intake on resistance training (RT)-induced muscle growth and determine potential heterogeneity.

Method: The PICO in this study is the following items: Population, healthy adults; Intervention, RT + protein intake; Comparison, placebo/no protein intake; Outcome, muscle hypertrophy. We will search the following electronic bibliographic databases: PubMed (MEDLINE), CINAHL, EMBASE, and CENTRAL. In addition, we will conduct the literature search in line with the PRISMA (preferred reporting items for systematic review and meta-analysis). Two authors will independently remove duplicate articles and screen titles and abstracts for eligibility. Thereafter, the two authors will retrieve the full text of these potentially eligible studies and assess them for the risk of bias, and then will extract data independently. Any discrepancies will be identified and resolved through discussion with other authors. Missing data will be requested from study authors. The extracted data will be analyzed by a meta-analysis, subgroup-analysis, and meta-regression.

Management information
Registered date
2021 Year 05 Month 27 Day
Last modified on
2021 Year 05 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050607

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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