UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028522 |
|---|---|
| Receipt number | 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 17:42:55 |
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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
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
m-yamada@imeq.co.jp
Sponsor or person
Institute
NIPPON FLOUR MILLS CO.,LTD.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032645
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
