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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027339
Receipt No. R000031328
Scientific Title brown rice
Date of disclosure of the study information 2017/05/14
Last modified on 2019/05/15

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Basic information
Public title brown rice
Acronym Brown Rice
Scientific Title brown rice
Scientific Title:Acronym Brown Rice
Region
Japan

Condition
Condition adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 brown rice
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Neutrophil activity,Phagocytosis activity,OxLDL
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 brown rice 2 pack (150g/pack) 8 weeks everyday
Interventions/Control_2 white rice 2 pack (150g/pack) 8 weeks everyday
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
70 years-old >
Gender Male and Female
Key inclusion criteria 20 years
Key exclusion criteria take some medicine
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Hiroyuki
Middle name
Last name Inagawa
Organization control of innate immunity TRA
Division name Research and development
Zip code 7610301
Address 3F bioRab From Kagawa, 2217-16 hayashi-cho, Takamastu city,Kagawa
TEL 087-813-9203
Email pxs07205@nifty.ne.jp

Public contact
Name of contact person
1st name Ran
Middle name
Last name Zhang
Organization control of innate immunity TRA
Division name Research and development
Zip code 7610301
Address 3F bioRab From Kagawa, 2217-16 hayashi-cho, Takamastu city,Kagawa
TEL 087-813-9203
Homepage URL http://shizenmeneki.org/
Email zhang@shizenmeneki.org

Sponsor
Institute control of innate immunity TRA
Institute
Department

Funding Source
Organization Cabinet Office
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization control of innate immunity TRA
Address 3F bioRab From Kagawa, 2217-16 hayashi-cho, Takamastu city,Kagawa
Tel 087-813-9201
Email zhang@shizenmeneki.org

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
2017 Year 05 Month 14 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
2017 Year 05 Month 10 Day
Date of IRB
2017 Year 02 Month 28 Day
Anticipated trial start date
2018 Year 02 Month 01 Day
Last follow-up date
2018 Year 08 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
2017 Year 05 Month 14 Day
Last modified on
2019 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031328

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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