UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study of effect of food containing plant ingredient on skin temperature
Title of the study (Brief title)	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	Hiroshi Ashigai
Organization	Kirin Company, Limited
Division name	Research Laboratories for Health Science and Food Technologies Research and Development Division
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	Hiroshi Ashigai
Organization	Kirin Company, Limited
Division name	Research Laboratories for Health Science and Food Technologies Research and Development Division
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 09 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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