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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028522
Receipt No. R000032645
Scientific Title A clinical study for evaluating the safety of excessive consumption of corn germ extract (glucosylceramide fraction)
Date of disclosure of the study information 2017/08/03
Last modified on 2017/08/03

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Basic information
Public title A clinical study for evaluating the safety of excessive consumption of corn germ extract (glucosylceramide fraction)
Acronym A clinical study for evaluating the safety of excessive consumption of corn germ extract
Scientific Title A clinical study for evaluating the safety of excessive consumption of corn germ extract (glucosylceramide fraction)
Scientific Title:Acronym 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
1st name
Middle name
Last name Saori Fujisaki
Organization NIPPON FLOUR MILLS CO.,LTD.
Division name Innovation center
Zip code
Address 5-1-3 Midorigaoka, Atsugi, Kanagawa, Japan
TEL 046-222-6963
Email s-fujisaki@nippn.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mayumi Yamada
Organization imeQ Co.Ltd.
Division name DM
Zip code
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)

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 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

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 Preinitiation
Date of protocol fixation
2017 Year 03 Month 29 Day
Date of IRB
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

Other
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

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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