UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017880 |
|---|---|
| Receipt number | R000020703 |
| Scientific Title | A study for evaluating the effects of intake of vegetable oil on the level of serum lipid in adult with slightly higher serum lipid : a double blind, placebo-controlled study |
| Date of disclosure of the study information | 2015/06/11 |
| Last modified on | 2015/11/11 23:05:13 |
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Basic information
Public title
A study for evaluating the effects of intake of vegetable oil on the level of serum lipid in adult with slightly higher serum lipid : a double blind, placebo-controlled study
Acronym
A study for evaluating the effects of intake of vegetable oil on the level of serum lipid in adult with slightly higher serum lipid
Scientific Title
A study for evaluating the effects of intake of vegetable oil on the level of serum lipid in adult with slightly higher serum lipid : a double blind, placebo-controlled study
Scientific Title:Acronym
A study for evaluating the effects of intake of vegetable oil on the level of serum lipid in adult with slightly higher serum lipid
Region
| Japan |
Condition
Condition
Adult with slightly higher serum lipid level
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of ingestion of a vegetable oil in adult with slightly higher serum lipid
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Serum lipid
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
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
Ingestion of vegetable oil for 12 consecutive weeks
Interventions/Control_2
Ingestion of placebo for 12 consecutive 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
| 20 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adult with slightly higher serum lipid level
Key exclusion criteria
1) Those who have been ingesting any article rich in active ingredient , tocopherols, docosahexaenoic acid, and eicosapentaenoic acid
2) Those who have been ingesting any article (such as health food and medicine) that may affect serum lipid level or lipid metabolism
3) Those who have suffering from any disease or who with a case history of a serious disease that needed medication
4) Those who have suffering from serious diseases such as diabetes mellitus or failure of the liver, kidney, or heart, or who with a case history of such
5) Those who might be liable to allergy during the study
6) Subjects who intend to become pregnant or lactating
7)Subjects judged as unsuitable for the study by the investigator for other reasons
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | 1)Sumio Kondo 2)Takayuki Ishikawa |
Organization
1)Medical Corporation Kensho-kai, Fukushima Healthcare Center
2)Nishi-Shinjyuku Kisaragi Clinic
Division name
1)Internal Medicine,Department of Neurosurgery 2)Internal Medicine
Zip code
Address
1)2-12-16 Tamagawa, Fukushima-ku, Osaka-shi, Osaka, 553-0004, Japan 2)6-6-2 Nishishinjuku, Sinjuku-ku, Tokyo, Japan
TEL
06-6441-6848.03-3344-0529
ko283434@ares.eonet.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chiharu Goto |
Organization
TTC Co., Ltd
Division name
Clinical Research Planning Department
Zip code
Address
1-20-2 Ebisunishi, shibuya-ku, Tokyo
TEL
03-5459-5329
Homepage URL
c.goto@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
non-disclosure
Organization
Division
Category of Funding Organization
Profit 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
| 2015 | Year | 06 | Month | 11 | 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
| 2014 | Year | 12 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Principal investingator's E-mail adress 2):saiyo@kisa-cl.com
Management information
Registered date
| 2015 | Year | 06 | Month | 11 | Day |
Last modified on
| 2015 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020703
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
