UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041939 |
|---|---|
| Receipt number | R000047868 |
| Scientific Title | The effect of high-amylose rice flour bread intake on blood glucose in patients with diabetes mellitus: A Randomized Controlled Trials |
| Date of disclosure of the study information | 2020/11/01 |
| Last modified on | 2022/01/31 22:44:47 |
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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
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
maruyama.kotatsu.rt@ehime-u.ac.jp
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047868
