UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042925 |
|---|---|
| Receipt number | R000048949 |
| Scientific Title | Study of ingestion of fatty acid and amino acid for muscle damage: a randomized, double-blind, placebo-controlled, parallel-group trial |
| Date of disclosure of the study information | 2021/01/15 |
| Last modified on | 2021/07/07 11:42:59 |
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Basic information
Public title
Study of fatty acid and amino acid for muscle damage
Acronym
Study of fatty acid and amino acid for muscle damage
Scientific Title
Study of ingestion of fatty acid and amino acid for muscle damage: a randomized, double-blind, placebo-controlled, parallel-group trial
Scientific Title:Acronym
Study of fatty acid and amino acid for muscle damage
Region
| Japan |
Condition
Condition
muscle damage
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the influence of fatty acid and amino acid for muscle damage following eccentric contractions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Before and after eccentric contraction (ECCs) with elbow flexors,
1)Range of motion
2)Maximal isometric contraction torque
3)Muscle soreness measured as a visual analog scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Ingestion of the placebo fatty acid oil (2.4 g/day) for 8 weeks before ECCs and for 6 days after ECCs.
Ingestion of the placebo starch (9.6 g/day) for 4 days before ECCs.
Interventions/Control_2
Ingestion of the placebo fatty acid oil (2.4 g/day) for 8 weeks before ECCs and for 6 days after ECCs.
Ingestion of the amino acid (9.6 g/day) for 4 days before ECCs.
Interventions/Control_3
Ingestion of the fatty acid oil (2.4 g/day) for 8 weeks before ECCs and for 6 days after ECCs.
Ingestion of the amino acid (9.6 g/day) for 4 days before ECCs.
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
Key inclusion criteria
Healthy male subjects
Key exclusion criteria
Subjects with
/resistance training more than five times a week for a year /no resistance training or exercise during over a year /serious liver, kidney, heart, respiratory, endocrine or metabolic diseases/ scheduled for surgery during this study/ administration of regular medication/ regular administration of supplements which affect this study / food allergies/ participation of other clinical trial during this study/ restriction of exercise/ any reason in the opinion of the lead principal investigator not to take part in this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Eisuke |
| Middle name | |
| Last name | Ochi |
Organization
Hosei University
Division name
Faculty of Bioscience and Applied Chemistry
Zip code
1848584
Address
3-7-2 Kajino, Koganei, Tokyo
TEL
042-387-6337
ochi@hosei.ac.jp
Public contact
Name of contact person
| 1st name | Eisuke |
| Middle name | |
| Last name | Ochi |
Organization
Hosei University
Division name
Faculty of Bioscience and Applied Chemistry
Zip code
1848584
Address
3-7-2 Kajino, Koganei, Tokyo
TEL
042-387-6337
Homepage URL
ochi@hosei.ac.jp
Sponsor or person
Institute
Hosei University
Faculty of Bioscience and Applied Chemistry
Institute
Department
Personal name
Funding Source
Organization
Nippon Suisan Kaisha Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Teikyo Heisei University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Teikyo Heisei University
Address
2-51-4, Higashiikebukuro, Toshima-ku, Tokyo, Japan
Tel
03-5843-3152
rec@thu.ac.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
| 2021 | Year | 01 | Month | 15 | 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
Completed
Date of protocol fixation
| 2020 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 06 | Day |
Last modified on
| 2021 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048949
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| Registered date | File name |
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