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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035168
Receipt No. R000040039
Scientific Title Evaluation of blood glucose response after intake of heat-moisture treated brown rice flour cracker.
Date of disclosure of the study information 2019/01/15
Last modified on 2019/03/25

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Basic information
Public title Evaluation of blood glucose response after intake of heat-moisture treated brown rice flour cracker.
Acronym Evaluation of blood glucose response after intake of heat-moisture treated brown rice flour cracker.
Scientific Title Evaluation of blood glucose response after intake of heat-moisture treated brown rice flour cracker.
Scientific Title:Acronym Evaluation of blood glucose response after intake of heat-moisture treated brown rice flour cracker.
Region
Japan

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

Objectives
Narrative objectives1 Comparison of blood gulcose response after intake of heat-moisture treated brown rice flour cracker with those of brown and polished rice flour crackers without heat-moisture treatment in adult volunteers.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes blood glucose levels, insulin levels
Key secondary outcomes Incremental area under the curve of blood glucose level (IAUCg), incremental area under the curve of blood insulin level (IAUCi), amyloid beta

Base
Study type Interventional

Study design
Basic design Cross-over
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 : heat-moisture treated koshiibuki brown rice flour cracker / dose : 60g / eating for 10min
Interventions/Control_2 Placebo food-1 : koshiibuki brown rice flour cracker / dose : 60g / eating for 10min
Interventions/Control_3 Placebo food-2 : polished koshiibuki rice flour cracker / dose : 60g / eating for 10min
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 1.Fasting plasma glucoce <126mg/dL.
2.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 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.Paticipants in other clinical trial.
6.Volunteers rejected participating in this study by chief investigator.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenichi Watanabe
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Medicine and Clinical Epidemiology for Prevention of Noncommunicable Diseases
Zip code
Address 1 Asahimachi-dori, Chuo-ku, Niigata, Japan (951-8510)
TEL 025-368-9026
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 Graduate School of Medical and Dental 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
2019 Year 01 Month 15 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
2018 Year 10 Month 31 Day
Date of IRB
2018 Year 11 Month 26 Day
Anticipated trial start date
2019 Year 01 Month 15 Day
Last follow-up date
2019 Year 03 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 12 Month 07 Day
Last modified on
2019 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040039

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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