UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061572 |
|---|---|
| Receipt number | R000070450 |
| Scientific Title | Non-randomized, open-label crossover comparative trial on the effects of food intake on blood glucose levels |
| Date of disclosure of the study information | 2026/08/31 |
| Last modified on | 2026/05/14 17:25:10 |
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Basic information
Public title
Non-randomized, open-label crossover comparative trial on the effects of food intake on blood glucose levels
Acronym
Non-randomized, open-label crossover comparative trial on the effects of food intake on blood glucose levels
Scientific Title
Non-randomized, open-label crossover comparative trial on the effects of food intake on blood glucose levels
Scientific Title:Acronym
Non-randomized, open-label crossover comparative trial on the effects of food intake on blood glucose levels
Region
| Japan |
Condition
Condition
N/A(healthy adults)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the time course of blood glucose levels due to food intake.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose levels
Key secondary outcomes
Plasma GLP-1 levels, Plasma insulin levels
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Single intake of test food > Washout period > Non-intake
Interventions/Control_2
Non-intake > Washout period > Single intake of test food
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Male or female Hayashikane Sangyo Co., Ltd. employees working at headquarters, aged 20-64 at the time of obtaining consent.
2. Those who have received a full explanation of the study content, fully understood it, and voluntarily given written consent to participate in the study.
3. Those who are not shift workers or night shift workers.
4. Those who are not participating in any other clinical trials.
5. Those who do not have allergies to the ingredients of the test product or the challenge food.
6. Those who do not regularly take any medications that may affect blood glucose levels.
7. Those who can quit smoking from the day of each efficacy evaluation until the end of measurement.
8. From the day before each efficacy evaluation until the end of measurement. Those who can abstain from alcohol immediately
9. Those who are not pregnant
10. Those who are not breastfeeding
11. Those who can stop taking health foods and supplements that may affect blood glucose levels from one week before the start of the efficacy evaluation until the last day of the efficacy evaluation
12. Those who are not anemic and can undergo frequent blood sampling (2 ml x 4 times per day for efficacy evaluation)
13. Those who have not had more than 200 ml of blood drawn or donated blood components within one month prior to the date of consent
14. Those who have never been diagnosed with diabetes
15. Those with chronic digestive diseases
16. Those who have never undergone gastrointestinal surgery
Key exclusion criteria
1. Pregnant individuals or those who may become pregnant during the study period, and breastfeeding individuals.
2. Individuals who have taken any supplements that affect blood glucose levels (excluding the test product) between one week before the start of the study and the last day of the study.
3. Individuals deemed unsuitable as study participants by the principal investigator.
4. Individuals who have eaten or drunk anything (excluding water, the test product, and the load food during the efficacy confirmation study) between 9 PM the day before the efficacy confirmation study and its end.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Noboru |
| Middle name | |
| Last name | Oosita |
Organization
Japan Community Healthcare Organization Shimonoseki Medical Center
Division name
Neurosurgery Department/Chair
Zip code
750-0061
Address
3-3-8,Kamisinticho, Shimonoseki-Shi, Yamaguchi, JAPAN
TEL
083-231-5811
ohshita-noboru@shimonoseki.jcho.go.jp
Public contact
Name of contact person
| 1st name | Shun |
| Middle name | |
| Last name | Namura |
Organization
Hayashikane Sangyo Co., Ltd.
Division name
Functional food division
Zip code
750-8608
Address
2-4-8 Yamatomachi, Shimonoseki-Shi, Yamaguchi, JAPAN
TEL
083-267-0094
Homepage URL
snamura@hayashikane.com
Sponsor or person
Institute
Hayashikane Sangyo Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Hayashikane Sangyo Co., Ltd.
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
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
03-5408-1599
jimukyoku@mail.souken-r.com
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 | 08 | Month | 31 | 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 | 04 | Month | 24 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2026 | Year | 05 | Month | 14 | Day |
Last modified on
| 2026 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070450
