UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055196 |
|---|---|
| Receipt number | R000063068 |
| Scientific Title | Comparative Effectiveness of Supplements for Muscle Mass Regulation with Resistance Exercise: A Systematic Review and Network Meta-Analysis |
| Date of disclosure of the study information | 2024/08/08 |
| Last modified on | 2024/08/08 15:49:29 |
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Basic information
Public title
Comparative Effectiveness of Supplements for Muscle Mass Regulation with Resistance Exercise: A Systematic Review and Network Meta-Analysis
Acronym
Comparative Effectiveness of Supplements for Muscle Mass Regulation with Resistance Exercise: A Systematic Review and Network Meta-Analysis
Scientific Title
Comparative Effectiveness of Supplements for Muscle Mass Regulation with Resistance Exercise: A Systematic Review and Network Meta-Analysis
Scientific Title:Acronym
Comparative Effectiveness of Supplements for Muscle Mass Regulation with Resistance Exercise: A Systematic Review and Network Meta-Analysis
Region
| Japan |
Condition
Condition
Healthy adults who were not suffering from any diseases (excluding those under 18, pregnant women, and lactating women).
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate and compare the efficacy of each supplement in promoting muscle hypertrophy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle Mass
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Systematic literature searches will be conducted using scientific databases and clinical trial registries. The selection criteria are as follows:
Participants (P): Individuals who do not have the disease (excluding those under 18 years of age, pregnant women, and lactating women)
Intervention (I): Intake of supplements (tablets, capsules, granules, beverages, processed foods) and implementation of resistance training.
Comparison (C): Oral intake of a placebo.
Outcome (O): The primary outcome is lean body mass.
Study design (S): Randomized controlled trials will be adopted.
Key exclusion criteria
Exclusion criteria are as follows:
Participants have a disease.
Use of substances other than supplements that have been reported to induce muscle hypertrophy.
Mixing of different major categories.
Special environments.
Studies aimed at weight loss or with energy restriction.
Studies focusing on biomarkers such as MPS rather than muscle hypertrophy as an outcome.
Athletes as participants.
Adolescents or children (minors).
Training specific to a sport as the exercise load (including cases where the exercise load amount cannot be identified or quantified).
Protocol papers or clinical trial registry data (including those reporting result values).
Studies with exercise performance in sports as the outcome.
Postoperative patients as participants (regardless of the duration since surgery).
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Yasuda |
Organization
Department of Health Management Tokai University
Division name
Department of Health Management
Zip code
259-1292
Address
4-1-1 Kitakaname, Hiratsuka-shi, Kanagawa 259-1292, JAPAN
TEL
0463-63-4394
yasuda.jun.w@tokai.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Yasuda |
Organization
Department of Health Management Tokai University
Division name
Department of Health Management
Zip code
259-1292
Address
4-1-1 Kitakaname, Hiratsuka-shi, Kanagawa 259-1292, JAPAN
TEL
0463-63-4394
Homepage URL
yasuda.jun.w@tokai.ac.jp
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
Funding Source
Organization
Tokai University
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
N/A
Address
N/A
Tel
N/A
N/A
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
| 2024 | Year | 08 | Month | 08 | 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
| 2024 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This research review will be conducted in accordance with PRISMA
Management information
Registered date
| 2024 | Year | 08 | Month | 08 | Day |
Last modified on
| 2024 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063068
