UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039127 |
|---|---|
| Receipt number | R000044623 |
| 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 |
| Date of disclosure of the study information | 2020/01/18 |
| Last modified on | 2021/07/26 14:53:23 |
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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
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
ochi@hosei.ac.jp
Sponsor or person
Institute
Hosei University
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044623
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