UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061296 |
|---|---|
| Receipt number | R000070137 |
| Scientific Title | Effect of Functional Cookies Containing Rice Bran and Okara on Postprandial Glycemic Response in Healthy Adults: A Randomized Crossover Study |
| Date of disclosure of the study information | 2026/04/17 |
| Last modified on | 2026/04/17 18:47:29 |
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Basic information
Public title
A Study on How Functional Cookies Made with Rice Bran and Okara Affect Postprandial Blood Glucose Levels
Acronym
ROG Study
Rice bran, Okara, Glycemia Study
Scientific Title
Effect of Functional Cookies Containing Rice Bran and Okara on Postprandial Glycemic Response in Healthy Adults: A Randomized Crossover Study
Scientific Title:Acronym
ROG Trial
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop cookies using rice bran and okara as raw materials, evaluate their palatability and their ability to suppress postprandial blood glucose elevation, and examine their potential as functional foods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in postprandial blood glucose levels
Incremental Area under the glucose curve (IAUC) from 0 to 180 min
Key secondary outcomes
Sensory evaluation scores (palatability comparison among samples A, B, and C)
Characteristics of glucose fluctuation patterns (rate of rise and decline)
Stability of blood glucose levels (glucose variability)
Insights into differences in glucose absorption related to dietary fiber type and food structure
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Participants consume butter cookies (Sample A), standardized to provide 50 g of carbohydrates, followed by continuous glucose monitoring for 3 hours.
Interventions/Control_2
Participants consume rice bran cookies (Sample B), standardized to provide 50 g of carbohydrates, followed by continuous glucose monitoring for 3 hours.
Interventions/Control_3
Participants consume okara cookies (Sample C), standardized to provide 50 g of carbohydrates, followed by continuous glucose monitoring for 3 hours.
Interventions/Control_4
Participants consume sucrose water (Sample D), adjusted to provide 50 g of carbohydrates, followed by continuous glucose monitoring for 3 hours.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 21 | years-old | <= |
Age-upper limit
| 26 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy young adult women
Aged approximately 18 to 25 years
Individuals who receive a full explanation of the study and provide written informed consent
Individuals who are able to wear a continuous glucose monitoring device and ingest the test cookies and sucrose solution without difficulty
Key exclusion criteria
Individuals with a history of diabetes, impaired glucose tolerance, or endocrine disorders
Individuals taking medications that may affect glucose metabolism
Individuals with food allergies to wheat, milk, eggs, soy, rice bran, okara, or related ingredients
Pregnant women or those who may be pregnant
Individuals deemed inappropriate for participation by the principal investigator
Target sample size
11
Research contact person
Name of lead principal investigator
| 1st name | MAIKO |
| Middle name | |
| Last name | KATO |
Organization
Sugiyama Jogakuen University
Division name
School of Life Studies
Zip code
4648662
Address
17-3 Hshigaoka-motomachi, Chikusa-ku,Nagoya,Aichi
TEL
052-781-4518
maiko-k@sugiyama-u.ac.jp
Public contact
Name of contact person
| 1st name | MAIKO |
| Middle name | |
| Last name | KATO |
Organization
Sugiyama Jogakuen University
Division name
School of Life Studies
Zip code
4648662
Address
17-3 Hshigaoka-motomachi, Chikusa-ku,Nagoya,Aichi
TEL
0527814518
Homepage URL
maiko-k@sugiyama-u.ac.jp
Sponsor or person
Institute
Sugiyama Jogakuen University
Institute
Department
Personal name
Funding Source
Organization
None
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
Sugiyama Jogakuen University
Address
17-3 Hshigaoka-motomachi, Chikusa-ku,Nagoya,Aichi
Tel
0527814518
maiko-k@sugiyama-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
| 2026 | Year | 04 | Month | 17 | 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
11
Results
CGM-based glucose measurements showed that Sample D (sucrose water) produced the most rapid glucose rise, with significantly higher glucose levels at 30 min compared with other trials. At 165 and 180 min, glucose levels in Trial D were significantly lower than in the other trials. The IAUC to 60 min was significantly larger in Trial D than in the other trials, and the IAUC to 120 min was significantly larger in Trial D than in Trial B.
Results date posted
| 2026 | Year | 04 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Female participants aged 20 to 24 years
Healthy young women with no history of glucose metabolism disorders.
Participant flow
Enrolled: 10
Consented: 10
Dropouts: 0
Analyzed: 10
Adverse events
No adverse events were observed.
Outcome measures
Primary outcome: Postprandial glucose levels measured by CGM (0 to 180 min)
Secondary outcomes: IAUC (0 to 60 min, 0 to 120 min), sensory evaluation scores
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2025 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2025 | Year | 10 | Month | 05 | Day |
Date trial data considered complete
| 2025 | Year | 10 | Month | 05 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 17 | Day |
Last modified on
| 2026 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070137
