UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058288 |
|---|---|
| Receipt number | R000066633 |
| Scientific Title | Confirmation test of postprandial blood glucose (Glycemic Index) values of test foods |
| Date of disclosure of the study information | 2025/06/27 |
| Last modified on | 2025/06/26 14:36:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Confirmation test of postprandial blood glucose (Glycemic Index) values of test foods
Acronym
Confirmation test of postprandial blood glucose (Glycemic Index) values of test foods
Scientific Title
Confirmation test of postprandial blood glucose (Glycemic Index) values of test foods
Scientific Title:Acronym
Confirmation test of postprandial blood glucose (Glycemic Index) values of test foods
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of intake of test foods on blood glucose level
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose level
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Kuchidoki Frozen Strawberry
Interventions/Control_2
Kuchidoki Frozen White Peach
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Healthy men between the ages of 20 and 50
2) BMI less than or equal to 30
3) Employees of Kewpie Corporation and Aohata Corporation who voluntarily wish to participate in the clinical trial and provide written consent.
4) Patients who have not been advised by a physician to receive treatment for a disease based on the results of a physical examination within the past year.
5) Patients who have no abnormalities in glucose tolerance based on tests conducted within the past year.
6)Those who are able to maintain a constant daily lifestyle during the study period.
Key exclusion criteria
1) Patients suffering from serious diseases (diabetes, heart disease, liver disease, kidney disease, cancer, etc.) or mental disorders
2) Patients with a history of serious diseases (diabetes, heart disease, liver disease, kidney disease, cancer, etc.) in the past
3) Patients who are classified as D by the Society of Physical Health Screening and Health Care
4) Those who are unable to maintain their daily lifestyle due to significant changes in diet and physical activity.
5) Patients with possible food allergy (strawberry, peach) or drug allergy to the test food.
6) Those who consume food for specified health use, health food, etc. on a daily basis.
7) Those who are taking drugs such as antihypertensive agents. Other patients who are deemed ineligible by the investigator to participate in this study
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Watanabe |
Organization
Watanabe Hospital
Division name
chairperson
Zip code
144-0043
Address
1-5-16, Haneda, Ota-ku, Tokyo, Japan
TEL
03-3741-0223
wnb.cto@gmail.com
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Sakashita |
Organization
Aohata Corporation
Division name
Research Center, Research and Development Division
Zip code
729-2392
Address
1-1-25 Tadakai-nakamachi, Takehara City, Hiroshima Prefecture
TEL
0846-26-0115
Homepage URL
yoshihiro_sakashita@aohata.co.jp
Sponsor or person
Institute
other
Institute
Department
Personal name
Funding Source
Organization
other
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee of Watanabe Hospital
Address
1-5-16, Haneda, Ota-ku, Tokyo, JAPAN
Tel
03-3741-0223
wnb@cto-net.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 | 27 | 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 | 06 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 05 | 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 | 26 | Day |
Last modified on
| 2025 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066633
