UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058097 |
|---|---|
| Receipt number | R000066399 |
| Scientific Title | Study on the effect of sweetened red bean paste made with date fruit on postprandial blood glucose levels |
| Date of disclosure of the study information | 2025/06/05 |
| Last modified on | 2025/06/05 17:58:26 |
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Basic information
Public title
Study on the effect of sweetened red bean paste made with date fruit on postprandial blood glucose levels
Acronym
Study on the effect of sweetened red bean paste made with date fruit on postprandial blood glucose levels
Scientific Title
Study on the effect of sweetened red bean paste made with date fruit on postprandial blood glucose levels
Scientific Title:Acronym
Study on the effect of sweetened red bean paste made with date fruit on postprandial blood glucose levels
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of sweetened red bean paste made with date fruit on postprandial blood glucose levels
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postprandial blood glucose level
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consumption of red bean paste made with sugar
Interventions/Control_2
Consumption of red bean paste made with date fruit
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
| 39 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy male and female
Key exclusion criteria
1) Individuals with allergies or aversions to date fruits, azuki beans, or bean paste
2) Individuals with a history of diabetes
3) Individuals with fasting blood glucose levels of 126 mg/dL or higher
4) Individuals currently undergoing treatment for a medical condition and taking medication
5) Individuals regularly taking medications, specific health foods, or dietary supplements that may affect the test
6) Pregnant or breastfeeding women
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Yoshimi |
| Middle name | |
| Last name | Kishimoto |
Organization
Setsunan University
Division name
Faculty of Agriculture
Zip code
5730101
Address
45-1, Nagaotoge-cho, Hirakata, Osaka
TEL
0728966352
yoshimi.kishimoto@setsunan.ac.jp
Public contact
Name of contact person
| 1st name | Yoshimi |
| Middle name | |
| Last name | Kishimoto |
Organization
Setsunan University
Division name
Faculty of Agriculture
Zip code
5730101
Address
45-1, Nagaotoge-cho, Hirakata, Osaka
TEL
0728966352
Homepage URL
yoshimi.kishimoto@setsunan.ac.jp
Sponsor or person
Institute
Setsunan University
Institute
Department
Personal name
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
Setsunan University Ethical Review Committee for Medical and Health Research Involving Human Subjects
Address
17-8, Ikedanaka-machi, Neyagawa, Osaka
Tel
0728001160
setsunan.kenkyu.shakai@josho.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 | 06 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 01 | Month | 14 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 08 | 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 | 06 | Month | 05 | Day |
Last modified on
| 2025 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066399
