UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of supplements containing coix seed on skin condition in Japanese women
Title of the study (Brief title)	Effect of coix seed on skin condition
Region	Japan

Condition
Condition	Healthy people
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect and the dose dependency of consecutive intake of supplements containing coix seed on Japanese adult women.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Skin condition (moisture, sebum, melanin and elasticity)
Key secondary outcomes	Biochemical analyses Physical measurements Questionnaire

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Supplements containing coix seed (1,500 mg of coix seed extract a day)
Interventions/Control_2	Supplements containing coix seed (1,000 mg of coix seed extract a day)
Interventions/Control_3	Placebo supplements not containing coix seed
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	Female
Key inclusion criteria	(1) no smoker (2) persons who is generally judged as healthy (3) persons who have no history of asthma (4) persons who have no allergic history to medicine, foods, and anything (5) persons who can give voluntary written consent to participate in the present trial
Key exclusion criteria	(1) persons who have any dietary supplements, quasi drugs or medicines which cause same or similar efficacy with the effect evaluated in this study (2) persons who have changed their habitats to take supplements within past 4 weeks. (3) Persons who work in night shift or in day and night shift (4) persons who have been treated their illness or prevention in a clinic at their informed consent (5) persons with their medical histories as follows: serious diseases of sugar metabolism,lipid metabolism, hepatic function, renal function, heart, circulatory, respiratory, endocrine system, immune system, or mental illness of the nervous system (6) persons with the medical histories of alcoholism or drug dependence (7) persons who might be developed allergic reaction to foods. (8) Persons who are pregnant, breast-feeding, or hope to be pregnant during the study period (9) persons who had always participated in or will participate in any other clinical trial (to use foods/medicine/quasi medicine/medical device) (10) persons who will not be judged suitable to the participants by the investigator.
Target sample size	45

Research contact person
Name of lead principal investigator	Kuniyoshi Shimizu
Organization	Faculty of Agriculture, Kyushu University
Division name	Laboratory of Systematic Forest and Forest Products Science
Address	6-10-1 Hakozaki, Higashi-ku, Fukuoka, Fukuoka, JAPAN
TEL	092-642-3002
Email	shimizu@agr.kyushu-u.ac.jp

Public contact
Name of contact person	Kuniyoshi Shimizu
Organization	Faculty of Agriculture, Kyushu University
Division name	Laboratory of Systematic Forest and Forest Products Science
Address	6-10-1 Hakozaki, Higashi-ku, Fukuoka, Fukuoka, JAPAN
TEL	092-642-3002
Homepage URL
Email	shimizu@agr.kyushu-u.ac.jp

Sponsor
Institute	Faculty of Agriculture, Kyushu University
Institute
Department

Funding Source
Organization	Shinnihonseiyaku Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Faculty of Humanity-Oriented Science and Engineering, Kindai University
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	2015 Year 08 Month 03 Day
Anticipated trial start date	2015 Year 09 Month 11 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 12 Month 11 Day
Last modified on	2016 Year 12 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028902