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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018823
Receipt No. R000021760
Scientific Title A clinical study for evaluating the safety of excessive consumption of rice bran extract(glucosylceramide fraction)
Date of disclosure of the study information 2015/09/01
Last modified on 2017/07/11

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Basic information
Public title A clinical study for evaluating the safety of excessive consumption of rice bran extract(glucosylceramide fraction)
Acronym A clinical study for evaluating the safety of excessive consumption of rice bran extract
Scientific Title A clinical study for evaluating the safety of excessive consumption of rice bran extract(glucosylceramide fraction)
Scientific Title:Acronym A clinical study for evaluating the safety of excessive consumption of rice bran extract
Region
Japan

Condition
Condition not for special condition
Classification by specialty
Medicine in general Dermatology
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 events 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 two capsules (10mg 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 who are able to take the test food for a month
6)Those who keep daily lifestyle during the test period
7)Those who are able to consent by the document
8)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 Rumiko Miyashita
Organization NIPPON FLOUR MILLS CO.,LTD. Central Laboratory
Division name Functional Foods Team
Zip code
Address 5-1-3 midorigaoka, Atsugi, Kanagawa, Japan
TEL 046-222-6963
Email miyashita@nippn.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi SAKURAI
Organization imeQ Co.Ltd.
Division name CRO Division
Zip code
Address 2-14-6 Nishi-Waseda, Sinjuku-Ku, Tokyo. 169-0075
TEL 03-6205-6222
Homepage URL
Email s-sakurai@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

Other administrative information
Date of disclosure of the study information
2015 Year 09 Month 01 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 Completed
Date of protocol fixation
2015 Year 08 Month 20 Day
Date of IRB
Anticipated trial start date
2015 Year 09 Month 03 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
2015 Year 08 Month 27 Day
Last modified on
2017 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021760

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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