UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the effects of plant extract on skin surface temperature and blood flow
Title of the study (Brief title)	Study of the effects of plant extract on skin surface temperature and blood flow
Region	Japan

Condition
Condition	No
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effects of plant extract on skin surface temperature and blood flow. To investigation of interaction of plant extract with a food ingredient.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	skin surface temperature (First observation, Second observation, Third observation) blood flow (First observation, Second observation, Third observation)
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	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Capsules containing plant extract, single daily ingestion.
Interventions/Control_2	Capsules containing plant extract and a food ingredient, single daily ingestion.
Interventions/Control_3	Placebo capsules not containing plant extract and a food ingredient, single daily ingestion.
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	60 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Individuals aged from 20 to 60 years, when giving the informed consent. (2) Individuals who give the informed consents in writing, after receiving enough explanation of the purpose and details of the study, understanding the study well, and deciding to attend the study with their own will.
Key exclusion criteria	(1) Individuals who are under treatment of some disease. (2) Individuals who have possibility of allergy symptoms onset. (3) Individuals who are under treatment of skin disease (e.g., atopic dermatitis). (4) Individuals who are, or are under treatment, or have a history of serious disease (e.g., liver disease, kidney disease, heart disease) or/and thyroid gland disease, adrenal gland disease, and/or metabolic disorder. (5) Individuals who are pregnant or lactating. (6) Individuals who are planned to participate in other clinical study during this study periods.
Target sample size	15

Research contact person
Name of lead principal investigator	Mika Miyake
Organization	Kirin Company, Limited
Division name	Research laboratories for health science & food technologies
Address	1-13-5,Fukuura,Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL	045-330-9837
Email	m-miyake@kirin.co.jp

Public contact
Name of contact person	Mika Miyake
Organization	Kirin Company, Limited
Division name	Research laboratories for health science & food technologies
Address	1-13-5,Fukuura,Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL	045-330-9837
Homepage URL
Email	m-miyake@kirin.co.jp

Sponsor
Institute	Kirin Company, Limited
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	2016 Year 12 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 15 Day
Anticipated trial start date	2016 Year 09 Month 26 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	2016 Year 09 Month 20 Day
Last modified on	2017 Year 09 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027755