UMIN-CTR Clinical Trial

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
Email	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
Email	nishiyama@toyo-rice.jp

Sponsor
Institute	TOYO RICE CORPORATION
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049903