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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046183
Receipt No. R000052687
Scientific Title Effect of intake of rice crackers prepared from high resistant starch rice (A-12) on increase in blood glucose levels.
Date of disclosure of the study information 2021/11/28
Last modified on 2021/11/25

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Basic information
Public title Effect of intake of rice crackers prepared from high resistant starch rice (A-12) on increase in blood glucose levels.
Acronym Effect of intake of rice crackers prepared from high resistant starch rice (A-12) on increase in blood glucose levels.
Scientific Title Effect of intake of rice crackers prepared from high resistant starch rice (A-12) on increase in blood glucose levels.
Scientific Title:Acronym Effect of intake of rice crackers prepared from high resistant starch rice (A-12) on increase in blood glucose levels.
Region
Japan

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

Objectives
Narrative objectives1 Evaluation of changes in postprandial blood glucose levels and insulin levels after intake of test and control foods, along with their incremental area under the curves of blood glucose levels (IAUCg) and insulin levels (IAUCi).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes blood glucose levels, IAUCg
Key secondary outcomes insulin levels, IAUCi

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Intake of test food (53.5 g ) and water (310 ml). > washout > intake of control food (50.4 g) and water (310 ml).
Interventions/Control_2 Intake of control food (50.4 g ) and water (310 ml). > washout > intake of test food (53.5 g) and water (310 ml).
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
65 years-old >
Gender Male and Female
Key inclusion criteria 1. Fasting plasma glucose <126mg/dL.
2.Individual having screening test result and questionnaire result judged to be appropriate for this study by investigator.
Key exclusion criteria 1. Diabetes mellitus under medical treatment.
2. Individual having severe diseases (e.g. Cerebrovascular, heart, kidney, gastrointestinal diseases. )
3. Individual received gastrectomy, enterectomy, and gastro-intestinal diseases, judged to be inappropriate for this study.
4. Pregnant, women having the possibility, and lactating women.
5. Participants in order clinical trial.
6. Individual rejected participating in this study by chief investigator.
Target sample size 16

Research contact person
Name of lead principal investigator
1st name Kenichi
Middle name
Last name Watanabe
Organization Niigata Bio-Research Park, Inc
Division name Advisor
Zip code 956-0841
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 Hiroshi
Middle name
Last name Goto
Organization Niigata Bio-Research Park, Inc
Division name Business promotion division
Zip code 956-0841
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 Akita Prefectural University
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 NBRC Research Ethics Review Committee
Address 316-2, Higashijima, Akiha-ku, Niigata, 956-0841, Japan
Tel 0250-25-1196
Email nbrp-food-navi@nbrp.co.jp

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
2021 Year 11 Month 28 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 Preinitiation
Date of protocol fixation
2021 Year 10 Month 15 Day
Date of IRB
Anticipated trial start date
2021 Year 11 Month 28 Day
Last follow-up date
2022 Year 02 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 11 Month 25 Day
Last modified on
2021 Year 11 Month 25 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052687

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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