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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036627
Receipt No. R000041630
Scientific Title Effects of size of rice bowl on managing intakes of rice -evaluations of the Diabetes Diet-Related QOL, conditions of diabetes, and management of intakes of rice-
Date of disclosure of the study information 2019/05/07
Last modified on 2019/04/30

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Basic information
Public title Effects of size of rice bowl on managing intakes of rice -evaluations of the Diabetes Diet-Related QOL, conditions of diabetes, and management of intakes of rice-
Acronym Effects of size of rice bowl on managing intakes of rice
Scientific Title Effects of size of rice bowl on managing intakes of rice -evaluations of the Diabetes Diet-Related QOL, conditions of diabetes, and management of intakes of rice-
Scientific Title:Acronym Effects of size of rice bowl on managing intakes of rice
Region
Japan

Condition
Condition type 2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to investigate the factors of intakes of rice and the effects of size of rice bowl on the Diabetes Diet-Related QOL, conditions of diabetes, and management of intakes of rice.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The Diabetes Diet-Related QOL
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 use the small size of rice bowl at meals for three months based on regular dietary counselling
Interventions/Control_2 use the own rice bowl at meals for three months based on regular dietary counselling
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
80 years-old >
Gender Male
Key inclusion criteria 1. Their HbA1c is under 8.5 %.
2. They eat rice one or more times in one day at home.
3. They have not changed meals, exercise, and medicines for the past three months.
Key exclusion criteria 1. They eat less rice than the amount of rice which they are instructed.
2. They use the smaller size of rice bowl than rice bowl in study.
3. They are limited the intakes of protein.
4. They are determined inappropriate for this study by doctor because of cognitive ability and other things.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Misa
Middle name
Last name Shimpo
Organization The University of Nagano
Division name Department of Food and Health Sciences, Faculty of Health and Human Development
Zip code 3808525
Address 8-49-7, Miwa, Nagano city, Nagano, 380-8525, Japan
TEL 0264621472
Email shimpo.misa@u-nagano.ac.jp

Public contact
Name of contact person
1st name Misa
Middle name
Last name Shimpo
Organization The University of Nagano
Division name Department of Food and Health Sciences, Faculty of Health and Human Development
Zip code 3808525
Address 8-49-7, Miwa, Nagano city, Nagano, 380-8525, Japan
TEL 0264621472
Homepage URL
Email shimpo.misa@u-nagano.ac.jp

Sponsor
Institute The University of Nagano
Institute
Department

Funding Source
Organization Ministry of education, culture, sports, science and technology
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 Department of Food and Health Sciences, Faculty of Health and Human Development, The University of Nagano
Address 8-49-7, Miwa, Nagano city, Nagano
Tel 0264621472
Email shimpo.misa@u-nagano.ac.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 医療法人TDE 糖尿病・内分泌内科クリニックTOSAKI(愛知県)

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 07 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
2019 Year 04 Month 19 Day
Date of IRB
2019 Year 02 Month 08 Day
Anticipated trial start date
2019 Year 05 Month 07 Day
Last follow-up date
2021 Year 01 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
2019 Year 04 Month 30 Day
Last modified on
2019 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041630

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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