UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062314 |
|---|---|
| Receipt number | R000071307 |
| Scientific Title | A comparative study on the effects of consuming red bean paste with varying polyphenol contents on blood glucose levels, using Yokan consumption as a reference. |
| Date of disclosure of the study information | 2026/07/24 |
| Last modified on | 2026/07/23 14:11:36 |
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Basic information
Public title
Multifaceted evaluation of the effects of Yokan consumption on postprandial blood glucose fluctuations.
Acronym
Effect of Yokan consumption on postprandial blood glucose fluctuations.
Scientific Title
A comparative study on the effects of consuming red bean paste with varying polyphenol contents on blood glucose levels, using Yokan consumption as a reference.
Scientific Title:Acronym
Evaluation of the effect on postprandial blood glucose levels after ingestion of red bean paste with varying polyphenol content.
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
testing the effects of Japanese sweets ingredients on reducing glycative stress
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose
Change in maximum blood glucose , and concentration(delta Cmax)
Incremental area under the curve(iAUC)
Key secondary outcomes
participant background survey, and
hematological test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
9
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
cooked rice
Interventions/Control_2
Smooth red bean paste
Interventions/Control_3
Smooth white bean paste 1
Interventions/Control_4
Smooth white bean paste 2
Interventions/Control_5
Yokan 1
Interventions/Control_6
Yokan 2
Interventions/Control_7
Yokan 3
Interventions/Control_8
Yokan 4
Interventions/Control_9
Yokan 5
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Men and women aged 18 to 59 at the time of obtaining consent for study participation
2) Healthy individuals with no chronic physical illnesses
3) Individuals who have received a full explanation of the study's purpose and content, possess the capacity to consent, fully understand the information, voluntarily wish to participate, and are able to provide written consent for participation
4) Individuals able to visit the designated location and undergo examinations on the scheduled dates
5) Individuals deemed suitable for participation in the study by the principal investigator
Key exclusion criteria
1)Individuals currently suffering from a medical condition and undergoing pharmacological treatment
2)Individuals with a history or current diagnosis of impaired glucose tolerance,psychiatric disorders,sleep disorders,hypertension,diabetes,hyperlipidemia,or other serious medical conditions
3)Individuals who have regularly taken medication for the treatment of a medical condition within the past month.
4)Individuals with a history or current diagnosis of serious disorders affecting the liver,kidneys,heart,lungs,blood,etc
5)Individuals with a history or current diagnosis of gastrointestinal disorders
6)Individuals with a BMI of 30 kg/m2 or higher
7)Individuals who have donated more than 200mL of blood within the past month or more than 400mL within the past three months
8)Individuals with severe anemia
9)Individuals at risk of allergic reactions to the test food,or at risk of severe allergic reactions to other foods or pharmaceuticals
10)Individuals who are pregnant,breastfeeding,or potentially pregnant
11)Individuals who currently-or within the past three months-regularly consume Foods with Function Claims or health foods marketed for effects on glucose metabolism.
12)Individuals otherwise deemed unsuitable for the study by the principal investigator
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yoshikazu |
| Middle name | |
| Last name | Yonei |
Organization
Doshisha university
Division name
Anti-Aging Medical Research Center,Faculty of Life and Medical Sciences
Zip code
610-0394
Address
1-3 Tatara Miyakodani,Kyotanabe City,Kyoto
TEL
0774656394
yyonei@mail.doshisha.ac.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Yokoi |
Organization
Toraya confectionery Co.,Ltd.
Division name
Production Support Department Laboratory
Zip code
412-0008
Address
1581 inno, gotemba city, Shizuoka
TEL
0550-89-6484
Homepage URL
t.yokoi@toraya-group.co.jp
Sponsor or person
Institute
Toraya confectionery Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Toraya confectionery Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Doshisha university
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Society of Glycative Stress Research
Address
6F,Nishishinjuku Mizuma Bldg,3-3-13 Nishishinjuku,Shinjuku-ku,Tokyo
Tel
03-6261-0732
info@toukastress.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
株式会社虎屋（静岡県）
同志社大学（京都府）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 24 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 09 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 25 | 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
| 2026 | Year | 07 | Month | 23 | Day |
Last modified on
| 2026 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071307
