UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062389 |
|---|---|
| Receipt number | R000065989 |
| Scientific Title | Research on the antihyperglycemic effect of synthetic rice |
| Date of disclosure of the study information | 2026/08/01 |
| Last modified on | 2026/07/29 17:19:46 |
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Basic information
Public title
Hyperglycemia control test with Syn-rice
Acronym
SRDM Trial
Scientific Title
Research on the antihyperglycemic effect of synthetic rice
Scientific Title:Acronym
SRBG Trial
Region
| Japan |
Condition
Condition
Type 2 Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Type 2 diabetes is known to cause postprandial hyperglycemia, and blood glucose fluctuations are known to be involved in the progression of diabetic complications. Synthetic rice (Shinrice) is a synthetic rice containing white kidney beans and konjac, and is a food that can be easily eaten by rehydrating it with water. It is known to suppress sugar absorption due to the action of white kidney beans grown in high altitude areas of the UK.
This study examines the effects of replacing regular breakfast with this Shinrice.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Suppression of postprandial hyperglycemia monitored by continuous blood glucose monitoring
2. Reduction of glycoalbumin value
Key secondary outcomes
Weight loss with a 4-week Shinrice diet
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
We will examine the benefits of replacing synthetic rice with regular breakfast. Measurement is performed using continuous blood glucose measurement (iPro-2).
Under normal diet, blood glucose is first measured for a week. Next, the breakfast rice is replaced with thin rice with the same carbohydrate content, and blood glucose is measured for a week.
Interventions/Control_2
After a 4-week synthetic rice breakfast, the weight is also measured to determine the weight loss effect. Glycoalbumon (GA) measurements are performed along with blood glucose measurements before and after.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients undergoing treatment for type 2 diabetes
Key exclusion criteria
1. HbA1c 9% or more
2. Ketosis
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | MASAO |
| Middle name | |
| Last name | NAGATA |
Organization
FUKUYAMA/SUKOYAKA CLINIC
Division name
Internal Medicine
Zip code
673-0018
Address
1-23, 3-chome, Nishiakashi Kita-machi,
TEL
09036120646
masao.med.nagata0122@icloud.com
Public contact
Name of contact person
| 1st name | MASAO |
| Middle name | |
| Last name | NAGATA |
Organization
Fukuyama Hospital
Division name
Internal Medicine
Zip code
655-0039
Address
5-55 , 2-chome, Suzuri-machi , Akashi City, Japan
TEL
0789271514
Homepage URL
masao.med.nagata0122@icloud.com
Sponsor or person
Institute
Fukuyama Hospital
Institute
Department
Personal name
Funding Source
Organization
MEETSHOP Co., Ltd.
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
Fukuyama Hospital
Address
5-55, 2-chime, suzurimachi, Akashi City, Hyogo Prefecture, Japan
Tel
0789271514
ijinkai@eos.ocn.ne.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
ふくやま病院 ふくやま・すこやかクリニック
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | 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
20
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
| 2025 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 29 | Day |
Last modified on
| 2026 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065989
