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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025642
Receipt No. R000029415
Scientific Title Functional study of sterile packaged cooked rice containing Koshihikari brown rice and black brown rice.
Date of disclosure of the study information 2017/01/24
Last modified on 2017/03/23

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Basic information
Public title Functional study of sterile packaged cooked rice containing Koshihikari brown rice and black brown rice.
Acronym Functional study of sterile packaged cooked rice containing Koshihikari brown rice and black brown rice.
Scientific Title Functional study of sterile packaged cooked rice containing Koshihikari brown rice and black brown rice.
Scientific Title:Acronym Functional study of sterile packaged cooked rice containing Koshihikari brown rice and black brown rice.
Region
Japan

Condition
Condition Healty volunteers
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparative evaluation of the time dependent changes of the postprandial blood glucose , insulin, incretin levels, and amyloid-beta as an indicator of cognitive impairment after ingestion of three types of sterile packaged cooked rice.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time-dependent changes in postprandiial blood glucose and insulin levels.
Key secondary outcomes Changes in incretin and amyloid-beta levels.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Control meal : Koshihikari white rice (150g) with water (200mL) > Washout period 1 week > Test meal-1 : Koshihikari brown rice and black brown rice (151.5g) with water (200mL) > Washout period 1 week > Test meal-2 : Heat-moisture treated rice (151.5g) with water (200mL)
Interventions/Control_2 Test meal-1 : Koshihikari brown rice and black brown rice (151.5g) with water (200mL) > Washout period 1 week > Test meal-2 : Heat-moisture treated rice (151.5g) with water (200mL) > Washout period 1 week > Control meal : Koshihikari white rice (150g) with water (200mL)
Interventions/Control_3 Test meal-2 : Heat-moisture treated rice (151.5g) with water (200mL) > Washout period week > Control meal : Koshihikari white rice (150g) with water (200mL) > Washout period 1 week > Test meal-1 : Koshihikari brown rice and black brown rice (151.5g) with water (200mL)
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
50 years-old >
Gender Male and Female
Key inclusion criteria 1.Body mass index (BMI) = <30.
2.Fasting plasma glucose 70-110mg/dl
3.Volunteers being able to make self-judgent to particupate in this study and giving written informed consent.
4.Volunteers having screening test results judged to be appropriate for this study by investigator.
Key exclusion criteria 1.Volunteers having severe history of the diseases (liver,kidney,hert,blood) judged to be inappropriate for this study.
2.Volunteers received gastrectomy,enterectomy,and gastro-intestinal dedeases,judged to be inappropriate for this study.
3.Volunteers having diabetes .
4.Volunteers rejected participating in this study by chief investigater.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenichi Watanabe
Organization Niigata Universty of Pharmacy and Applied Life Sciences
Division name Laboratory of Clinical pharmacology
Zip code
Address 265-1, Higashijima, Akiha-ku, Niigata City
TEL 0250-25-5267
Email watanabe@nupals.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Niigata Bio-Research Park, Inc
Organization Niigata Bio-Research Park, Inc
Division name Business promotion division
Zip code
Address 316-2 Higashijima, Akiha-ku, Niigata, 956-0811, Japan
TEL 0250-25-1196
Homepage URL
Email goto@nbrp.co.jp

Sponsor
Institute Niigata Bio-Research Park , Inc
Institute
Department

Funding Source
Organization Niigata University of Phamacy and Applied Life Sciences , Faculty of Applied Life Sciences.
Organization
Division
Category of Funding Organization Other
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
2017 Year 01 Month 24 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
2016 Year 12 Month 13 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 25 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
2017 Year 01 Month 12 Day
Last modified on
2017 Year 03 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029415

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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