UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058146 |
|---|---|
| Receipt number | R000066161 |
| Scientific Title | Survey on blood glucose level changes after meals with different carbohydrate content and nutritional content, and blood glucose-related parameters |
| Date of disclosure of the study information | 2025/06/16 |
| Last modified on | 2025/06/10 19:51:46 |
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Basic information
Public title
Survey on blood glucose level changes after meals with different carbohydrate content and nutritional content, and blood glucose-related parameters
Acronym
Survey on blood glucose level changes after meals with different carbohydrate content and nutritional content, and blood glucose-related parameters
Scientific Title
Survey on blood glucose level changes after meals with different carbohydrate content and nutritional content, and blood glucose-related parameters
Scientific Title:Acronym
Survey on blood glucose level changes after meals with different carbohydrate content and nutritional content, and blood glucose-related parameters
Region
| Japan |
Condition
Condition
Able-bodied person
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Ascertain changes in postprandial blood glucose levels following ingestion of the test foods.
Comprehensively analyze postprandial blood glucose change patterns, individual characteristics, and the nutritional components of the test foods.
Ascertain the correlation between postprandial blood glucose change and vascular endothelial function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose
Key secondary outcomes
Vascular endothelial function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
The participants consumed 10 meals for lunch
Interventions/Control_2
The participants consumed 10 meals for lunch
Interventions/Control_3
The participants consumed 10 meals for lunch
Interventions/Control_4
The participants consumed 10 meals for lunch
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Healthy men and women whose most recent health check results show that their glucose metabolism is in the high normal range
(fasting blood glucose level is 100-125mg/dL or HbA1c is 5.6-6.4%)
2) Subjects who have been fully informed of the purpose and content of the study and have voluntarily agreed to participate in writing
Key exclusion criteria
1) Those currently undergoing treatment for or with a history of malignant tumors, heart failure, or myocardial infarction
2) Those with a pacemaker or implantable cardioverter defibrillator
3) Those currently undergoing treatment for the following chronic diseases: arrhythmia, liver disorder, kidney disorder, cerebrovascular disease, rheumatism, diabetes, dyslipidemia, hypertension, and other chronic diseases
4) Those who plan to take medicines, over-the-counter medicines (OTC), herbal medicines, health foods, and supplements, including foods for specified health uses and foods with functional claims, that may affect the study during the study period
5) Those with allergies (to medicines or research-related foods)
6) Those who are pregnant, breastfeeding, or intend to become pregnant during the study period
7) Individuals who have participated in other clinical trials within one month prior to obtaining the consent form, or who are scheduled to participate in other clinical trials during the study period.
8) Individuals who are otherwise deemed inappropriate by the study director to be subjects of the study.
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Soma |
| Middle name | |
| Last name | Ode |
Organization
Macromill, Inc.
Division name
Life Science Division
Zip code
1080075
Address
Shinagawa East One Tower. 11F, 2-16-1 Konan, Minato-ku, Tokyo, JAPAN
TEL
03-6716-0700
ohde@macromill.com
Public contact
Name of contact person
| 1st name | Ayumi |
| Middle name | |
| Last name | Sugioka |
Organization
Macromill, Inc.
Division name
Life Science Division
Zip code
1080075
Address
Shinagawa East One Tower. 11F, 2-16-1 Konan, Minato-ku, Tokyo, JAPAN
TEL
03-6716-0700
Homepage URL
sugioka@macromill.com
Sponsor or person
Institute
Macromill, Inc.
Institute
Department
Personal name
Funding Source
Organization
Ezaki Glico 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
Mibyou Research Ethics Review Committee
Address
2-18-4 Kandamisakicho,Chiyoda-ku, Tokyo
Tel
03-6272-9163
renraku@npo-mibyou.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
一般社団法人うめきた未来イノベーション機構
UMEKITA FUTURE INNOVATION ORGANIZATION
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 16 | 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 | 04 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 07 | 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 | 10 | Day |
Last modified on
| 2025 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066161
