UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058705 |
|---|---|
| Receipt number | R000067119 |
| Scientific Title | An intervention study investigating the effect of high-amylose brown rice consumption on blood glucose levels and its long-term feasibility. |
| Date of disclosure of the study information | 2025/08/05 |
| Last modified on | 2025/08/05 19:16:57 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
An intervention study investigating the effect of high-amylose brown rice consumption on blood glucose levels and its long-term feasibility.
Acronym
An intervention study investigating the effect of high-amylose brown rice consumption on blood glucose levels and its long-term feasibility.
Scientific Title
An intervention study investigating the effect of high-amylose brown rice consumption on blood glucose levels and its long-term feasibility.
Scientific Title:Acronym
An intervention study investigating the effect of high-amylose brown rice consumption on blood glucose levels and its long-term feasibility.
Region
| Japan |
Condition
Condition
glucose abnormality
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Brown rice and high-amylose rice are thought to have beneficial effects on blood glucose levels.
However, no studies have specifically investigated the effects of high-amylose brown rice on blood glucose.
Brown rice tends to absorb water poorly and is harder to digest compared to white rice.
When cooked in a regular rice cooker using the same method as for white rice, brown rice may not absorb enough water or gelatinize properly. This can make it harder and less sticky, and may also reduce its digestibility.
Many foods show their health benefits only when eaten regularly over time.
Therefore, in this study, participants were asked to cook and eat the rice in their usual home environment, using their own rice cookers and preferred methods.
This approach allowed us to observe how people naturally prepared and ate the rice, and to identify cooking and eating methods that made the rice easier to consume.
Based on this, the study aimed to examine the effects of high-amylose brown rice on blood glucose levels, and to explore how to make it more acceptable and easier to eat in daily life.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood glucose levels, HbA1c
Key secondary outcomes
Bowel movement frequency and stool characteristics
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Daily consumption (equal to or more than 1 serving/day) of high-amylose brown rice (Hoshinishiki) for four weeks
Interventions/Control_2
Control
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
| 40 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The persons aged 40-74 with HbA1c levels between 5.6% and 6.4%, based on a health checkup within the past year.
Key exclusion criteria
1. Under treatment for diabetes
2. Regularly visiting a doctor without physician's approval
3. Rice allergy
4. Deemed unsuitable by the principal investigator or collaborating physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Koutatsu |
| Middle name | |
| Last name | Maruyama |
Organization
Ehime University
Division name
Graduate School of Agriculture
Zip code
790-8566
Address
3-5-7 Tarumi, Matsuyama, Ehime
TEL
089-946-9960
kenkyu_madoguchi@ehimechn.org
Public contact
Name of contact person
| 1st name | Koutatsu |
| Middle name | |
| Last name | Maruyama |
Organization
Ehime University
Division name
Graduate School of Agriculture
Zip code
790-8566
Address
3-5-7 Tarumi, Matsuyama, Ehime
TEL
089-946-9960
Homepage URL
kenkyu_madoguchi@ehimechn.org
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
Koutatsu Maruyama
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
Institutional Review Board,Ehime University Hospital
Address
454 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
| 2025 | Year | 08 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 04 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 05 | Day |
Last follow-up date
| 2028 | Year | 03 | 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
| 2025 | Year | 08 | Month | 05 | Day |
Last modified on
| 2025 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067119
