UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034675 |
|---|---|
| Receipt number | R000039398 |
| Scientific Title | Short-term intake of the high-amylose rice (Ehime Prefecture grown) in inpatients with diabetes mellitus: A non-randomized clinical trial. |
| Date of disclosure of the study information | 2018/11/05 |
| Last modified on | 2022/01/31 22:42:43 |
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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
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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039398
