UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027339
Receipt number R000031328
Scientific Title brown rice
Date of disclosure of the study information 2017/05/14
Last modified on 2019/05/15 16:14:44

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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 or person

Institute

control of innate immunity TRA

Institute

Department

Personal name



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

Value
https://center6.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