UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020273 |
|---|---|
| Receipt number | R000023405 |
| Scientific Title | The benefit of fish oil for health promotion in healthy adults. |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2017/01/19 09:34:43 |
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Basic information
Public title
The benefit of fish oil for health promotion in healthy adults.
Acronym
The benefit of fish oil for health promotion in healthy adults.
Scientific Title
The benefit of fish oil for health promotion in healthy adults.
Scientific Title:Acronym
The benefit of fish oil for health promotion in healthy adults.
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To check the benefit and safety of fish oil
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
serum TG, Cholesterol, NEFA, QOL
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
fish oil supplement 12/day x 4 weeks
Interventions/Control_2
fish can food 4 days/week X 4weeks, 1can(75g fish) per day
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
healthy adults, male and female, 20-60 years old
Key exclusion criteria
people who eat fish every day
people who take medicine
people who are diagnosed any disease including metabolic syndrome
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Sakaue |
Organization
Tokushima University
Division name
Nutrition and Metabolism
Zip code
Address
3-18-15 Kumamoto, Tokushima
TEL
088-633-9214
rtsutsumi@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rie Tsutsumi |
Organization
Tokushima University
Division name
Nutrition and Metabolism
Zip code
Address
3-18-15 Kuramoto, Tokushima
TEL
088-633-9214
Homepage URL
rtsutsumi@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
MAFF, MEXT
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 04 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 18 | Day |
Last modified on
| 2017 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023405
