UMIN-CTR Clinical Trial

Basic information
Public title	Short-term intake of the high-amylose rice (Ehime Prefecture grown) in inpatients with diabetes mellitus: A non-randomized clinical trial.
Acronym	Intervention study of high-amylose rice intake in inpatients with diabetes mellitus.
Scientific Title	Short-term intake of the high-amylose rice (Ehime Prefecture grown) in inpatients with diabetes mellitus: A non-randomized clinical trial.
Scientific Title:Acronym	Intervention study of high-amylose rice intake in inpatients with diabetes mellitus.
Region	Japan

Condition
Condition	Diabetes mellitus
Classification by specialty	Medicine in general Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	It is highly useful that study of the functional rice in dietetic therapy. Thus, the objective of this study is to examins the effect of high-amylose rice on postprandial continuous glucose levels and rice preferences.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Continuous glucose monitoring data after rice intake: glycemic fluctuation, postprandial blood glucose, hypoglycemia, nocturnal blood glucose
Key secondary outcomes	Amount of dietary intake, rice preferences

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Food
Interventions/Control_1	The high-amylose rice is applied for 3 days and the normal rice is applied for 4 days
Interventions/Control_2
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	74 years-old >=
Gender	Male and Female
Key inclusion criteria	The Ehime University Hospital's in-patients with diabetes mellitus who are 20 to 74 years old and the BMI is from 18.5 to 35.0kg/m2
Key exclusion criteria	1. The persons who are in the treatment of malignant neoplasm, ischemic heart disease, cerebrovascular disease, chronic kidney failure, dementia or severe gastrointestinal disease. 2. The person in the period of pregnancy and lactation. 3. The patients who are unsuited to participate the study.
Target sample size	35

Research contact person
Name of lead principal investigator	1st name Koutatsu Middle name Last name Maruyama
Organization	Ehime University
Division name	Laboratory of Community Health and Nutrition, Special Course of Food and Health Science Department of Bioscience, Graduate School of Agriculture
Zip code	790-8566
Address	3-5-7 Tarumi, Matsuyama, Ehime
TEL	089-946-9960
Email	maruyama.kotatsu.rt@ehime-u.ac.jp

Public contact
Name of contact person	1st name Koutatsu Middle name Last name Maruyama
Organization	Ehime University
Division name	Laboratory of Community Health and Nutrition, Special Course of Food and Health Science Department o
Zip code	790-8566
Address	3-5-7 Tarumi, Matsuyama, Ehime
TEL	089-946-9960
Homepage URL
Email	maruyama.kotatsu.rt@ehime-u.ac.jp

Sponsor
Institute	Ehime University
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ehime University
Address	Shitsukawa, Toon, Ehime
Tel	089-960-5172
Email	rinri@m.ehime-u.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

Other administrative information
Date of disclosure of the study information	2018 Year 11 Month 05 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	No longer recruiting
Date of protocol fixation	2018 Year 08 Month 03 Day
Date of IRB	2018 Year 10 Month 22 Day
Anticipated trial start date	2018 Year 11 Month 01 Day
Last follow-up date	2019 Year 08 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	2018 Year 10 Month 28 Day
Last modified on	2022 Year 01 Month 31 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039398