UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical study for evaluating the safety of excessive consumption of corn germ extract (glucosylceramide fraction)
Title of the study (Brief title)	A clinical study for evaluating the safety of excessive consumption of corn germ extract
Region	Japan

Condition
Condition	not for special condition
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate the safety of overdose ceramide
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The number of the adverse event which have the causal relationship between the test food observed during test period
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	One capsule (10 mg of glucosylceramide ) a day
Interventions/Control_2
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	60 years-old >=
Gender	Male and Female
Key inclusion criteria	1)20<=age<=60 2)Male and female 3)Outpatients 4)Healthy adults 5)Those with normal blood test results (or evaluated by the primary investigator). 6)Those who are able to take the test food for a month 7)Those who keep daily lifestyle during the test period 8)Those who are able to consent by the document 9)Those who are not correspond to the exclusion criteria
Key exclusion criteria	1)Those who are with a history of treatment such as myocardial infarction or heart failure 2)Exclusion for diseases (atrial fibrillation, arrhythmia, liver failure, renal failure, cerebrovascular disease, arthritis, diabetes, dyslipidemia, those being treated with high blood pressure, and other chronic diseases, etc.) 3)Who are corresponding the criteria D of the scale of health screening Society 4)Those who take any drugs and supplements (including herbal medicine) 5)Those who are allergic (pharmaceuticals and test article-related food) 6)Those who are Pregnancy or lactation, or to be expected pregnant during the study period 7)Those who are participating in other clinical trials within a month 8)Those who has been determined to be inappropriate of the study
Target sample size	15

Research contact person
Name of lead principal investigator	Saori Fujisaki
Organization	NIPPON FLOUR MILLS CO.,LTD.
Division name	Innovation center
Address	5-1-3 Midorigaoka, Atsugi, Kanagawa, Japan
TEL	046-222-6963
Email	s-fujisaki@nippn.co.jp

Public contact
Name of contact person	Mayumi Yamada
Organization	imeQ Co.Ltd.
Division name	DM
Address	2-14-6 nishiwaseda shinjyu-city, Tokyo
TEL	03-6205-6222
Homepage URL
Email	m-yamada@imeq.co.jp

Sponsor
Institute	NIPPON FLOUR MILLS CO.,LTD.
Institute
Department

Funding Source
Organization	NIPPON FLOUR MILLS CO.,LTD.
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	医療法人社団　札幌百合の会病院 SAPPORO YURINOKAI HOSPITAL

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 03 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 03 Month 29 Day
Anticipated trial start date	2017 Year 08 Month 08 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	2017 Year 08 Month 03 Day
Last modified on	2017 Year 08 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032645