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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024391
Receipt No. 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

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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
Email 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
Email k1minami@bioindustry.nodai.ac.jp

Sponsor
Institute Tokyo University of Agriculture
Institute
Department

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
Email

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
URL(English) https://upload.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
Registered date File name


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