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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031738
Receipt No. R000036239
Scientific Title A study of effect of food containing plant ingredient on skin temperature
Date of disclosure of the study information 2019/03/12
Last modified on 2018/03/15

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Basic information
Public title A study of effect of food containing plant ingredient on skin temperature
Acronym A study of effect of food containing plant ingredient on skin temperature
Scientific Title A study of effect of food containing plant ingredient on skin temperature
Scientific Title:Acronym A study of effect of food containing plant ingredient on skin temperature
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
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Skin temperature
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 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 and Food Technologies Research and Development Division
Zip code
Address 1-17-1,Namamugi,Tsurumi-ku,Yokohama 230-8628 Japan
TEL 080-1930-9950
Email 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 and Food Technologies Research and Development Division
Zip code
Address 1-17-1,Namamugi,Tsurumi-ku,Yokohama 230-8628 Japan
TEL 080-1930-9950
Homepage URL
Email Hiroshi_Ashigai@kirin.co.jp

Sponsor
Institute Kirin Company, Limited
Institute
Department

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
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

Other administrative information
Date of disclosure of the study information
2019 Year 03 Month 12 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
2011 Year 09 Month 21 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 06 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 03 Month 15 Day
Last modified on
2018 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036239

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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