UMIN-CTR Clinical Trial

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	Completed
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	2019 Year 07 Month 04 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	2020 Year 11 Month 02 Day

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