UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032521 |
|---|---|
| Receipt number | R000037089 |
| Scientific Title | A study of effect of food containing plant ingredient on skin temperature and cutaneous blood flow |
| Date of disclosure of the study information | 2019/05/01 |
| Last modified on | 2018/05/08 20:58:35 |
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Basic information
Public title
A study of effect of food containing plant ingredient on skin temperature and cutaneous blood flow
Acronym
A study of effect of food containing plant ingredient on skin temperature and cutaneous blood flow
Scientific Title
A study of effect of food containing plant ingredient on skin temperature and cutaneous blood flow
Scientific Title:Acronym
A study of effect of food containing plant ingredient on skin temperature and cutaneous blood flow
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of food containing plant ingredient on skin temperature and cutaneous blood flow
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin temperature
cutaneous blood flow
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingestion of food containing plant ingredient component food
Interventions/Control_2
Ingestion of food not containing plant ingredient component food
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
1)Japanese subjects of both sexes above 20 years old- under 65 years old at the point of obtaining informed consent
2)Subjects who competent to consent and give voluntary consent in writing with full understanding after receiving explanation of this study aim and contents.
Key exclusion criteria
1)Subjects who is under treatment.
2)Subjects who have risk to develop allergy.
3)Subjects who have serious diabetes, hepatic disorder (liver inflammation), kidney disorder, and cardiac disorder, or subjects who have history of medication for thyroid disorder, adrenal gland disorder, and other metabolic disease
4)Subjects who are willing to become pregnant or lactation during this study
5)Subjects who participated in other clinical trial within 1 month prior to obtaining informed consent, or subjects who are planning to participate other clinical trial during this study
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Ashigai |
Organization
Kirin Company, Limited
Division name
Research Laboratories for Health Science & Food Technologies Research & Development Division
Zip code
Address
1-17-1,Namamugi,Tsurumi-ku,Yokohama 230-8628 Japan
TEL
080-1930-9950
Hiroshi_Ashigai@kirin.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Ashigai |
Organization
Kirin Company, Limited
Division name
Research Laboratories for Health Science & Food Technologies Research & Development Division
Zip code
Address
1-17-1,Namamugi,Tsurumi-ku,Yokohama 230-8628 Japan
TEL
080-1930-9950
Homepage URL
Hiroshi_Ashigai@kirin.co.jp
Sponsor or person
Institute
Kirin Company, Limited
Institute
Department
Personal name
Funding Source
Organization
Kirin Company, Limited
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
| 2019 | Year | 05 | 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
Completed
Date of protocol fixation
| 2012 | Year | 09 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 30 | 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
| 2018 | Year | 05 | Month | 08 | Day |
Last modified on
| 2018 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037089
| 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 |
