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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030710
Receipt No. R000034911
Scientific Title Study on the variables related to blood glucose control and safety of long-term ingestion of sterile packaged cooked rice.
Date of disclosure of the study information 2018/01/10
Last modified on 2018/06/21

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Basic information
Public title Study on the variables related to blood glucose control and safety of long-term ingestion of sterile packaged cooked rice.
Acronym Study on the variables related to blood glucose control and safety of long-term ingestion of sterile packaged cooked rice.
Scientific Title Study on the variables related to blood glucose control and safety of long-term ingestion of sterile packaged cooked rice.
Scientific Title:Acronym Study on the variables related to blood glucose control and safety of long-term ingestion of sterile packaged cooked rice.
Region
Japan

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

Objectives
Narrative objectives1 Evaluation of blood glucose suppression effects and safety of long-term ingestion of packaged cooked rice with black rice or with barley.
Evaluation of suppressive effects of amyloid beta and advanced glycation end products (AGE) .
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Variables related to blood glucose control (blood glucose level, inslin, HOMA-IR, IAUCg, IAUCi (0-120min)) , safety
Key secondary outcomes Amyloid beta, HbA1c, AGE, Acceptability

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are 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 Test food -1 :12-week intake of packaged rice cooked with black brown rice (40%), super-hard rice (40%), and koshihikari brown rice (20%), followed by high pressure treatment (200MPa).
Interventions/Control_2 Test food -2 : 12week intake of packaged rice cooked with koshihikari (50%) and barley (50%), followed by high pressure treatment (200MPa).
Interventions/Control_3 Pracebo food : 12-week intake of koshihikari packaged cooked rice .
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1.Volunteers of higher IAUC responders to white rice in healthy subjects, by finger - prick blood measurement at 0 (pre intake), 15, 30, 45, 60, 90 and 120min post intake of white rice.
2.Fasting plasma glucose = <140mg/dL.
3.Volunteer having screening test result and questionnaire result judged to be appropriate for this study by investigator.
Key exclusion criteria 1.Diabetes under medical treatment.
2.Volunteers having severe diseases (e.g. liver, kindney, heart, blood diseases, and infections requiring the notification)
3.Volunteers received gastrectomy, enterectomy, and gastro-intestinal diseases, juded to be inappropriate for this study.
4.Pregnant, women having the possibility, and lactating women.
5.Volunteers rejected participating in this study by chief investigator.
Target sample size 36

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenichi Watanabe
Organization Niigata Bio-Research Park, Inc
Division name Advisor
Zip code
Address 316-2 Higashijima, Akiha-ku, Niigata, 956-0841, Japan
TEL 0250-25-1196
Email wataken@med.niigata-u.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, 956-0841, 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
2018 Year 01 Month 10 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 11 Month 08 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 10 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
2018 Year 01 Month 06 Day
Last modified on
2018 Year 06 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034911

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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