UMIN-CTR Clinical Trial

Basic information
Public title	Influence of ingestion of eicosapentaenoic acid-rich fish oil on exercise-induced fatigue for middle-aged persons: a randomized, double-blind, placebo-controlled, parallel-group trial
Acronym	Trial for influence of eicosapentaenoic acid on exercise -induced fatigue
Scientific Title	Influence of ingestion of eicosapentaenoic acid-rich fish oil on exercise-induced fatigue for middle-aged persons: a randomized, double-blind, placebo-controlled, parallel-group trial
Scientific Title:Acronym	Trial for influence of eicosapentaenoic acid on exercise -induced fatigue
Region	Japan

Condition
Condition	Exercise-induced fatigue
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to investigate the influence of eicosapentaenoic acid for exercise induced fatigue.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Subjective evaluation of fatigue by visual analogue 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	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Food
Interventions/Control_1	Tested material: EPA-rich fish oil Dosage: 2.4g/day Duration: 8 weeks
Interventions/Control_2	Tested material: corn oil Dosage: 2.4g/day Duration: 8 weeks
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	50 years-old <=
Age-upper limit	59 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Healthy males and females aged 50 to 59 years old at the time of acquiring informed consent 2)Subjects without exercise habits
Key exclusion criteria	(1) Subjects with BMI over 30 kg/m2 (2) Subjects who have ever been diagnosed with chronic fatigue syndrome (3) Subjects suffering from diseases and visiting hospital, medication or treatment ( exclusion of pollen allergy treatment and medicine) (4) Subjects who eat blue fish (horse mackerel, mackerel, sardine, saury, etc) for more than 4 days a week (5) Subjects with difficulty walking for long time (6) Subjects who are taking medicines (such as pharmaceuticals based on ethyl icosapentate) or supplements and foods (EPA, DHA, GABA, citric acid, imidazole dipeptide, astaxanthin, Coenzyme Q10 etc.) that have an influence on the test results (7) Subjects who is pregnant or willing to be pregnant or breast-feeding during this study (8) Subjects who have a previous and a current medical history of serious heart disease, hepatopathy, kidney damage and digestive organ (9) Subjects with abnormal electrocardiogram in the past (10) Subjects with excessive consumption of alcohol (11) Subjects whose eating habits are extremely irregular and individuals whose life rhythms are irregular (12) Subjects with allergy to test products, the others food or medicine (13) Subjects who have being participate in other clinical research, individuals who are planned to participate in other clinical research within 4 weeks after the end of the study, or subjects who are planned to participate in other clinical study after informed consent for the current study (14) Subjects who donated a large amount of blood before the start of the current study (15) Subjects who are judged as unsuitable for the study by the investigator for other reasons
Target sample size	20

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	184-8584
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	184-8584
Address	3-7-2 Kajino, Koganei, Tokyo
TEL	042-387-6337
Homepage URL
Email	ochi@hosei.ac.jp

Sponsor
Institute	Hosei University
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
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board of Chiyoda Paramedical Care Clinic
Address	2F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel	03-5297-5548
Email	IRB@cpcc.co.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	法政大学生命科学部（東京都） （Hosei Univesity Faculty of Bioscience）

Other administrative information
Date of disclosure of the study information	2020 Year 01 Month 18 Day

Related information
URL releasing protocol	None
Publication of results	Unpublished

Result
URL related to results and publications	None
Number of participants that the trial has enrolled	20
Results	No difference between groups.
Results date posted	2021 Year 07 Month 26 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	1)Healthy males and females aged 50 to 59 years old at the time of acquiring informed consent 2)Subjects without exercise habits
Participant flow	After 8-week supplementation, all subject started walking.
Adverse events	None
Outcome measures	exercise induced fatigue
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 12 Month 20 Day
Date of IRB	2019 Year 12 Month 20 Day
Anticipated trial start date	2020 Year 01 Month 20 Day
Last follow-up date	2020 Year 03 Month 25 Day
Date of closure to data entry	2020 Year 04 Month 30 Day
Date trial data considered complete	2020 Year 05 Month 30 Day
Date analysis concluded	2020 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date	2020 Year 01 Month 11 Day
Last modified on	2021 Year 07 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044623