UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060600 |
|---|---|
| Receipt number | R000069314 |
| Scientific Title | Observation of Blood Glucose Fluctuations Following the Consumption of Rice Koji Amazake During Golf Rounds and in Daily Life |
| Date of disclosure of the study information | 2026/02/06 |
| Last modified on | 2026/02/06 13:12:39 |
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Basic information
Public title
Observation of Blood Glucose Fluctuations Following the Consumption of Rice Koji Amazake During Golf Rounds and in Daily Life
Acronym
Observation of Blood Glucose Fluctuations Following the Consumption of Rice Koji Amazake During Golf Rounds and in Daily Life
Scientific Title
Observation of Blood Glucose Fluctuations Following the Consumption of Rice Koji Amazake During Golf Rounds and in Daily Life
Scientific Title:Acronym
Observation of Blood Glucose Fluctuations Following the Consumption of Rice Koji Amazake During Golf Rounds and in Daily Life
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effects of specific beverage consumption on postprandial blood glucose levels and blood glucose variability in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint of this study is blood glucose fluctuations from 0 to 120 minutes after beverage consumption.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 39 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Female
Key inclusion criteria
The inclusion criteria for this study are healthy adults aged 39 years, without metabolic disorders such as diabetes, who understand the study content and have provided written informed consent.
Key exclusion criteria
The exclusion criteria for this study are as follows:
1) Individuals diagnosed with diabetes (type 1 or type 2) or other metabolic disorders
2) Individuals using medications that affect blood glucose levels
3) Individuals with food allergies that make it difficult to consume the beverages used in this study
4) Pregnant or breastfeeding individuals
5) Individuals deemed unsuitable by the principal investigator
6) Individuals with skin conditions at the Freestyle Libre 2 application site
7) Individuals unable to wear the continuous glucose monitoring device
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | Taichi |
| Middle name | |
| Last name | Hara |
Organization
Waseda University
Division name
School of Human Sciences
Zip code
359-1192
Address
2-579-15, Mikajima, Tokorozawa City, Saitama Prefecture
TEL
04-2947-6848
harata1@waseda.jp
Public contact
Name of contact person
| 1st name | Kana |
| Middle name | |
| Last name | Honda |
Organization
Waseda University
Division name
Faculty of Human Sciences
Zip code
359-1192
Address
2-579-15, Mikajima, Tokorozawa City, Saitama Prefecture
TEL
090-5984-2877
Homepage URL
kana-honda@fuji.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Waseda University
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
Waseda University
Address
2-579-15, Mikajima, Tokorozawa City, Saitama Prefecture
Tel
04-2947-6848
kana-honda@fuji.waseda.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 | 02 | Month | 06 | 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 | 02 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This research is conducted as exploratory research by students. There is no funding from companies or conflicts of interest.
Management information
Registered date
| 2026 | Year | 02 | Month | 06 | Day |
Last modified on
| 2026 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069314
