UMIN-CTR Clinical Trial

Basic information
Public title	The effect of the high-amylose rice flour bread intake on blood glucose in patients with diabetes mellitus: A Randomized Controlled Trials
Acronym	Randomized Controlled Trials of the effect of high-amylose rice flour bread intake on blood glucose in diabetes patients
Scientific Title	The effect of high-amylose rice flour bread intake on blood glucose in patients with diabetes mellitus: A Randomized Controlled Trials
Scientific Title:Acronym	Randomized Controlled Trials of the effect of high-amylose rice flour bread intake on blood glucose in diabetes patients
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	Several studies reported that higher high-amylose rice intake regulates postprandial blood glucose levels. Thus, the objective of this study is to examine whether high-amylose rice flour bread intake regulates blood glucose levels assessed by continuous glucose monitoring.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Continuous glucose monitoring data after rice flour bread intake: glycemic fluctuation, postprandial blood glucose, hypoglycemia, nocturnal blood glucose
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	For the early intervention group, the high-amylose rice flour bread is applied for the first 1-3 days. After those days, the control bread is applied for 1-3 days.
Interventions/Control_2	For the later intervention group, the control bread is applied for the first 1-3 days. After those days, the high-amylose rice flour bread is applied for 1-3 days.
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	79 years-old >=
Gender	Male and Female
Key inclusion criteria	The in-patient with diabetes mellitus of Ehime University Hospital who aged 20 to 79 years and BMI is ranged between 18.5 and 35.0kg/m2
Key exclusion criteria	- Pregnant or lactating women - The patients who are unsuited to participate in the study decided by the doctor. - The person who is allergic to ingredients contained in bread such as wheat, rice, eggs, etc.
Target sample size	40

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
Zip code	7908566
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	7908566
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	Other
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	089-960-5040
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	2020 Year 11 Month 01 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	Open public recruiting
Date of protocol fixation	2020 Year 06 Month 01 Day
Date of IRB	2020 Year 08 Month 25 Day
Anticipated trial start date	2020 Year 11 Month 01 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry	2021 Year 12 Month 31 Day
Date trial data considered complete	2022 Year 02 Month 01 Day
Date analysis concluded	2025 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2020 Year 09 Month 29 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=R000047868