UMIN-CTR Clinical Trial

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
Email	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
Email	ochi@hosei.ac.jp

Sponsor
Institute	Hosei University Faculty of Bioscience and Applied Chemistry
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048949