UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060639 |
|---|---|
| Receipt number | R000069352 |
| Scientific Title | Effects of Food Intake on Postprandial Blood Glucose Levels in Healthy Adults |
| Date of disclosure of the study information | 2026/02/10 |
| Last modified on | 2026/02/10 10:29:24 |
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Basic information
Public title
Effects of Food Intake on Postprandial Blood Glucose Levels in Healthy Adults
Acronym
Effects of Food Intake on Postprandial Blood Glucose Levels in Healthy Adults
Scientific Title
Effects of Food Intake on Postprandial Blood Glucose Levels in Healthy Adults
Scientific Title:Acronym
Effects of Food Intake on Postprandial Blood Glucose Levels in Healthy Adults
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will evaluate the effects of various foods consumed on postprandial blood glucose levels in human trials. We will examine the relationship between food intake and blood glucose response from the perspective of glycative stress and glucose metabolic homeostasis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximum change in glucose level and incremental area under the curve (iAUC) after food intake.
Key secondary outcomes
Time-course changes in postprandial glucose levels and glycemic index estimation.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Various foods including rice, bread, confectionery, fruits, tea, and nuts.
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
| 20 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Ages 20 to 30
Healthy
Able to consent
Able to visit
Physician determines appropriate
Key exclusion criteria
Diabetes and other conditions
Currently undergoing medication
BMI over 30
Pregnancy/breastfeeding
Food allergies
Glucose metabolism-related health food intake habits
Physician's judgment
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshikazu |
| Middle name | |
| Last name | Yonei |
Organization
Doshisha University
Division name
Anti-Aging Medical Research Center,Faculty of Life and Medical Sciences
Zip code
6100394
Address
1-3 Tatara Miyakodani,Kyotanabe City,Kyoto
TEL
0774656394
yyonei@mail.doshisha.ac.jp
Public contact
Name of contact person
| 1st name | Yoshikazu |
| Middle name | |
| Last name | Yonei |
Organization
Doshisha University
Division name
Anti-Aging Medical Research Center,Faculty of Life and Medical Sciences
Zip code
6100394
Address
1-3 Tatara Miyakodani,Kyotanabe City,Kyoto
TEL
0774656394
Homepage URL
yyonei@mail.doshisha.ac.jp
Sponsor or person
Institute
Doshisha University
Institute
Department
Personal name
Yoshikazu Yonei
Funding Source
Organization
Doshisha University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee on Research Involving Human Subjects at Doshisha University
Address
Imadegawa Street, Karasuma East, Kamigyo Ward, Kyoto City
Tel
075-251-3158
ji-oer@mail.doshisha.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
同志社大学 京田辺キャンパス 医心館
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 10 | 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 | 30 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2026 | 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
| 2026 | Year | 02 | Month | 10 | Day |
Last modified on
| 2026 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069352
