UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056929 |
|---|---|
| Receipt number | R000063159 |
| Scientific Title | Brown Rice vs. White Rice: Impact of Glycemic Index on Sleepiness |
| Date of disclosure of the study information | 2025/02/04 |
| Last modified on | 2025/02/04 14:24:29 |
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Basic information
Public title
Brown Rice vs. White Rice: Impact of Glycemic Index on Sleepiness
Acronym
BR-WR GID Study
Scientific Title
Brown Rice vs. White Rice: Impact of Glycemic Index on Sleepiness
Scientific Title:Acronym
BR-WR GID Study
Region
| Japan |
Condition
Condition
Post-meal Sleepiness
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is not uncommon to experience overwhelming sleepiness after lunch, making it difficult to focus on studies or work. We hypothesized that this post-lunch sleepiness might be related to a rapid drop in blood glucose levels. Therefore, this study aims to test the hypothesis that consuming brown rice, which has a low glycemic index (GI) and a more gradual effect on blood glucose levels, can reduce post-meal sleepiness. We will compare this with a control group that consumes an equivalent amount of white rice. The study will examine in detail the effects of brown rice consumption on sleepiness (the primary endpoint), concentration, blood glucose levels, and physiological indicators of the autonomic nervous system. We hope that the findings from this study will help in preventing sleepiness through conscious dietary choices based on GI levels.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleepiness: Stanford Sleepiness Scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Brown rice diet
Interventions/Control_2
White rice diet
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
| 18 | years-old | <= |
Age-upper limit
| 25 | years-old | >= |
Gender
Female
Key inclusion criteria
Students from the Department of Human Nutrition at Tokyo Kasei Gakuin University
Individuals with a BMI of 18.5 to 24.9
Key exclusion criteria
Individuals with sleep disorders
Individuals currently receiving medical treatment (regardless of diagnosis)
Individuals with a habit of skipping breakfast
Individuals who have taken medication within 24 hours of the study day
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Mitsuhiko |
| Middle name | |
| Last name | Yamada |
Organization
Tokyo Kasei Gakuin University
Division name
Department of Pathophysiology, School of Human Nutrition
Zip code
102-8341
Address
22 Sanban-cho, Chiyoda-ku, Tokyo
TEL
03-3262-2563
yamada.mitsuhiko@kasei-gakuin.ac.jp
Public contact
Name of contact person
| 1st name | Mitsuhiko |
| Middle name | |
| Last name | Yamada |
Organization
Tokyo Kasei Gakuin University
Division name
Department of Pathophysiology, School of Human Nutrition
Zip code
102-8341
Address
22 Sanban-cho, Chiyoda-ku, Tokyo
TEL
03-3262-2563
Homepage URL
yamada.mitsuhiko@kasei-gakuin.ac.jp
Sponsor or person
Institute
Tokyo Kasei Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Kasei Gakuin University
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Kasei Gakuin University Ethics Review Committee
Address
22 Sanban-cho, Chiyoda-ku, Tokyo
Tel
03-3262-2251
rec@kasei-gakuin.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 | 02 | Month | 04 | 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
15
Results
Consumption of a retort-packaged brown rice product reduced postprandial drowsiness. However, contrary to expectations, the white rice group, which showed stronger drowsiness, had a more gradual increase in interstitial glucose concentration. No correlation was found between drowsiness and glycemic index (GI), suggesting that GI differences did not affect drowsiness. Future studies on GI differences should carefully consider food selection.
Results date posted
| 2025 | Year | 02 | Month | 04 | Day |
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
Completed
Date of protocol fixation
| 2024 | Year | 04 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2024 | Year | 10 | 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 | 02 | Month | 04 | Day |
Last modified on
| 2025 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063159
