UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043778 |
|---|---|
| Receipt number | R000049903 |
| Scientific Title | Study on health effects of ingesting "Ripened Extract Made of Sub-aleurone Layer and Crushed Cell Group Taken out from Brown Rice" |
| Date of disclosure of the study information | 2021/03/31 |
| Last modified on | 2021/09/27 09:56:50 |
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Basic information
Public title
Study on health effects of ingesting "Ripened Extract Made of Sub-aleurone Layer and Crushed Cell Group Taken out from Brown Rice"
Acronym
Study on health effects of ingesting "Ripened Extract Made of Sub-aleurone Layer and Crushed Cell Group Taken out from Brown Rice"
Scientific Title
Study on health effects of ingesting "Ripened Extract Made of Sub-aleurone Layer and Crushed Cell Group Taken out from Brown Rice"
Scientific Title:Acronym
Study on health effects of ingesting "Ripened Extract Made of Sub-aleurone Layer and Crushed Cell Group Taken out from Brown Rice"
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to conduct a questionnaire survey on the health effects of ingesting "Ripened Extract Made of Sub-aleurone Layer and Crushed Cell Group Taken out from Brown Rice" for one month and evaluate it.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
QOL questionnaire survey
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
Ingest "Ripened Extract Made of Sub-aleurone Layer and Crushed Cell Group Taken out from Brown Rice"
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
[1]Japanese males and females aged 18-99 years
[2]Individuals who are healthy and are not received treatment of disease
[3]Individuals whose written informed consent has been obtained
[4]Individuals judged appropriate for the study by the principal
Key exclusion criteria
[1]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, lung disease,or blood disease
[2]Individuals who are sensitive to test products or Individual with fear who causes severe allergy in a food and medical supplies
[3]Individuals judged inappropriate for the study by the principal
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Seki |
Organization
TOYO RICE CORPORATION
Division name
Planning and Public Relations Department
Zip code
104-0061
Address
5-10-13,Ginza,Chuo-ku,Tokyo
TEL
03-3572-7550
seki-hiroyuki@toyo-rice.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Nishiyama |
Organization
TOYO RICE CORPORATION
Division name
Special Mission Sales Department
Zip code
640-8341
Address
12,Kuroda,Wakayama-City,Wakayama
TEL
073-471-3011
Homepage URL
nishiyama@toyo-rice.jp
Sponsor or person
Institute
TOYO RICE CORPORATION
Institute
Department
Personal name
Funding Source
Organization
TOYO RICE CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Anti-Aging Medical Research Center,Graduate School of Life and Medical Sciences,Doshisha University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Society of Glycative Stress Research
Address
5F-11,Musashino Bldg,2-13-10 Shinjuku,Shinjuku-ku,Tokyo
Tel
03-6709-8842
rinri-glycativestress@antiaging-bank.com
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
| 2021 | Year | 03 | Month | 31 | 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
1023
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
| 2021 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 22 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 29 | Day |
Last modified on
| 2021 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049903
