UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024391 |
|---|---|
| Receipt number | R000028076 |
| Scientific Title | Research about the effect that Sach inchi oil gives metabolism and a vascular function |
| Date of disclosure of the study information | 2016/10/15 |
| Last modified on | 2017/04/19 09:10:45 |
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Basic information
Public title
Research about the effect that Sach inchi oil gives metabolism and a vascular function
Acronym
Effect of Sach inchi oi to physiology
Scientific Title
Research about the effect that Sach inchi oil gives metabolism and a vascular function
Scientific Title:Acronym
Effect of Sach inchi oi to physiology
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Purpose is to investigate the effect that Sach inchi oil causes to metabolism and a vascular function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Respiratory quotient four hours later from uptake.
Flow mediated vasodilation four hours later from uptake.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
single dose
an intake of the Sach inchi oil:350mg
Interventions/Control_2
single dose
an intake of the Canola oil oil:350mg
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
| 24 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The person who is normal without any kind of disease
Key exclusion criteria
having a disease
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Minami |
Organization
Tokyo University of Agriculture
Division name
Department of Bio - industry
Zip code
Address
196 Yasaka Abashiri City Hokkaido, Japan
TEL
0152-48-3869
k1minami@bioindustry.nodai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Minami |
Organization
Tokyo University of Agriculture
Division name
Department of Bio - industry
Zip code
Address
196 Yasaka Abashiri City Hokkaido, Japan
TEL
0152-48-3869
Homepage URL
k1minami@bioindustry.nodai.ac.jp
Sponsor or person
Institute
Tokyo University of Agriculture
Institute
Department
Personal name
Funding Source
Organization
Tokyo University of Agriculture
Organization
Division
Category of Funding Organization
Other
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
東京農業大学生物産業学部（北海道）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | 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 | 10 | Month | 13 | Day |
Last modified on
| 2017 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028076
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
