UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029181 |
|---|---|
| Receipt number | R000033362 |
| Scientific Title | Effect of Pike oil in healthy subjects as phase II and III study |
| Date of disclosure of the study information | 2017/09/18 |
| Last modified on | 2020/09/18 14:35:34 |
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Basic information
Public title
Effect of Pike oil in healthy subjects as phase II and III study
Acronym
Phase II/III study for pike oil benefits
Scientific Title
Effect of Pike oil in healthy subjects as phase II and III study
Scientific Title:Acronym
Phase II/III study for pike oil benefits
Region
| Japan |
Condition
Condition
Adults Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the benefit of pike oil in healthy subjects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of FMD levels
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
4 weeks intake of pike oil
Interventions/Control_2
4 weeks intake of placebo
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
<=20,<60 years healthy subjects
Key exclusion criteria
patients who diagnosed/treated lipid abnormal or any disease
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Sakaue |
Organization
Tokushima University
Division name
Nutrition and Metabolism
Zip code
7708503
Address
3-18-15 Kumamoto, Tokushima
TEL
088-633-9249
hsakaue@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Rie |
| Middle name | |
| Last name | Tsutsumi |
Organization
Tokushima University
Division name
Nutrition and Metabolism
Zip code
7708503
Address
3-18-15 Kuramoto, Tokushima
TEL
088-633-9249
Homepage URL
rtsutsumi@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University hospital
Institute
Department
Personal name
Funding Source
Organization
JSPS
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokushima University Hospital
Address
2-50-1 Kuramoto Tokushima
Tel
81-88-633-9294
awachiken@tokushima-u.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
徳島大学
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 18 | 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
| 2017 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 18 | Day |
Last modified on
| 2020 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033362
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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