UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044344 |
|---|---|
| Receipt number | 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 | 2023/11/29 17:52:58 |
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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
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
55fhyanh@gmail.com
Sponsor or person
Institute
Japan Institute of Sports Sciences, Japan Sport Council
Institute
Department
Personal name
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
Not applicable because of the study design (systematic review)
Address
Not applicable because of the study design (systematic review)
Tel
Not applicable
Not applicable
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
Not applicable
Publication of results
Unpublished
Result
URL related to results and publications
Not applicable
Number of participants that the trial has enrolled
1797
Results
Interventions with protein intake were found to be effective in increasing lean body mass from resistance training. On the other hand, significant inter-study heterogeneity was identified in the results of the meta-analysis studies.
Results date posted
| 2023 | Year | 11 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy subjects
Participant flow
Interventions with protein intake were found to be effective in increasing lean body mass from resistance training. On the other hand, significant inter-study heterogeneity was identified in the results of the meta-analysis studies.
Adverse events
Not applicable
Outcome measures
Muscle mass, lean mass, fat mass
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 20 | Day |
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
| 2023 | Year | 02 | Month | 28 | Day |
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.
Because our study design is a systematic review, this study is not approved by any ethics committee. Thus, we do not fill forms related to IRB.
Management information
Registered date
| 2021 | Year | 05 | Month | 27 | Day |
Last modified on
| 2023 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050607
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