UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037848 |
|---|---|
| Receipt number | R000043151 |
| Scientific Title | A Study on the effect of eicosapentaenoic acid ･docosahexaenoic acid on mental fatigue |
| Date of disclosure of the study information | 2019/08/31 |
| Last modified on | 2020/02/03 16:54:02 |
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Basic information
Public title
A Study on the effect of eicosapentaenoic acid ･docosahexaenoic acid on mental fatigue
Acronym
Effect of eicosapentaenoic acid ･docosahexaenoic acid on mental fatigue
Scientific Title
A Study on the effect of eicosapentaenoic acid ･docosahexaenoic acid on mental fatigue
Scientific Title:Acronym
Effect of eicosapentaenoic acid ･docosahexaenoic acid on mental fatigue
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of eicosapentaenoic acid･docosahexaenoic acid on mental fatigue
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
･Subjective symptom questionnaire on fatigue (VAS) before and after mental workload
･Subjective symptom questionnaire on fatigue (VAS) for awakening
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test food: intake of fish oil containing eicosapentaenoic acid ･docosahexaenoic acid
6 capsules/day, 12 weeks
Interventions/Control_2
Placebo food: intake of corn oil not containing eicosapentaenoic acid ･docosahexaenoic acid
6 capsules/day, 12 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
| 35 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Subjects who tend to get tired easily by usual desk works
2) Healthy males and females aged 35 to 60 years old at the time of acquiring informed consent
3) Subjects who can make self-judgement and are voluntarily giving written informed consent
Key exclusion criteria
1) Subjects who have a history of serious liver disorder, kidney disorder, heart disease
2) Subjects who are suffering from diseases and who are visiting hospital, medication or treatment
3) Subjects who are suspected to be depression or menopausal disorder
4) Subjects who have ever been diagnosed with chronic fatigue syndrome
5) Subjects who are likely to have allergic symptoms due to the tested component
6)Subjects who eat blue fish (maize, mackerel, sardine, saury, etc) for more than 4 days a week
7) Subjects who are taking medicines (such as pharmaceuticals based on ethyl icosapentate) or supplements (EPA, DHA, GABA, citric acid, imidazole dipeptide, astaxanthin, Coenzyme Q10 etc.) that have an influence on the test results
8)Subjects who is pregnant or willing to be pregnant or breast-feeding during this study
9) Subjects with irregular shift work and late night work
10) Subjects who exercise for over an hour every day
11)Alcoholic drinkers (more than 60 grams of pure alcohol per day for more than 5 days a week)
12) Subjects participating in other clinical trials or willing to participate in other clinical trials
13) Subjects who are judged as unsuitable for the study by the investigator for other reasons
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Suzuki |
Organization
Shinagawa Season terrace Health Care clinic
Division name
General Manager of Medical Examination Department/ Doctor
Zip code
108-0075
Address
5F Shinagawa Season Terrace Bld., 1-2-70 Kounan, Minato-ku, Tokyo, Japan
TEL
03-3452-3382
satoru_suzuki@sempos.or.jp
Public contact
Name of contact person
| 1st name | Yoshika |
| Middle name | |
| Last name | Komori |
Organization
KSO Co., Ltd
Division name
Sales department
Zip code
105-0023
Address
7F Shibaura Omodaka Bld., 1-9-7 Shibaura, Minato-ku, Tokyo, Japan
TEL
03-3452-7733
Homepage URL
yoshi@kso.co.jp
Sponsor or person
Institute
KSO Co., Ltd
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
Ethical Committee of Shinagawa Season Terrace Health Care Clinic
Address
5F Shinagawa Season Terrace Bld., 1-2-70 Kounan, Minato-ku, Tokyo, Japan
Tel
03-3452-3382
tomohiro_kogo@sempos.or.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
一般財団法人船員保険会 品川シーズンテラス健診クリニック
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 31 | 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
60
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
| 2019 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 29 | Day |
Last modified on
| 2020 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043151
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