UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023002 |
|---|---|
| Receipt number | R000026470 |
| Scientific Title | The effects fish oil to improve serum lipid level in subjects with borderline hyperlipidemia |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2017/01/19 09:22:50 |
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Basic information
Public title
The effects fish oil to improve serum lipid level in subjects with borderline hyperlipidemia
Acronym
The effects fish oil on borderline hyperlipidemia
Scientific Title
The effects fish oil to improve serum lipid level in subjects with borderline hyperlipidemia
Scientific Title:Acronym
The effects fish oil on borderline hyperlipidemia
Region
| Japan |
Condition
Condition
patients with borderline hyperlipidemia
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to determine the effect of fish oil on improvement of hyperlipidemia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FMD, serum lipid (cholesterol, TG)
Key secondary outcomes
body fat
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
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
fish oil
Interventions/Control_2
olive oil
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
adult
male and female
20-65 years old
TG; 50-199 mg/dL
BT: under 159/99 mmHg
LDL cholesterol 120-159 mg/dL
BMI under 30cm/m2
subjects who do not take medicine for hyperlipidemia
Key exclusion criteria
1) severe disease including stoke, heart disease, kidney failure
2) after surgery of gastrointestinal tract
3) chronic disease
4) hyperchoresterol with family history
5) abnormal hyperlipidemia
6) severe anemia
7) severe diarrea
8) pregnant
9)allergy with fish
10 already taking medicine or supplement for serum lipid
11) eating fish every day
12) alcohol dependance
13) donation of blood in these 2 weeks
14) participant of other clinical trial in these month
15) other
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Sakaue |
Organization
Tokushima University
Division name
Division of Tokushima University
Zip code
Address
3-18-15 Kumamoto, Tokushima
TEL
088-633-9249
hsakaue@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rie Tsutsumi |
Organization
Tokushima University
Division name
Division of Tokushima University
Zip code
Address
3-18-15 Kuramoto, Tokushima
TEL
088-633-9214
Homepage URL
rtsutumi@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Ministry of agriculture
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
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 | 08 | 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
Date of protocol fixation
| 2016 | Year | 07 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | 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
| 2016 | Year | 07 | Month | 04 | 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=R000026470
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
