UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060402 |
|---|---|
| Receipt number | R000069100 |
| Scientific Title | Mechanisms Underlying Differences in Postprandial Glycemic Responses After Breakfast and Dinner Intake, with a Focus on Digestive and Absorptive Function |
| Date of disclosure of the study information | 2026/01/19 |
| Last modified on | 2026/01/19 17:07:53 |
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Basic information
Public title
Elucidation of the Mechanisms Underlying Differences in Glycemic Responses After Breakfast and Dinner Intake: A Perspective on Digestive and Absorptive Function
Acronym
Breakfast Dinner Glycemic Response Study
Scientific Title
Mechanisms Underlying Differences in Postprandial Glycemic Responses After Breakfast and Dinner Intake, with a Focus on Digestive and Absorptive Function
Scientific Title:Acronym
Breakfast Dinner Glycemic response
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the mechanisms responsible for differences in postprandial glycemic responses between breakfast and dinner, focusing on digestive and absorptive functions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Superior mesenteric artery blood flow, Gastric emptying
Key secondary outcomes
Blood glucose levels, Plasma Insulin, Plasma Free fatty acid, Energy metabolism
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
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
Ten healthy adults will consume a 400-kcal liquid meal (two bottles of Meibalance Mini) in the morning (09:00). Superior mesenteric artery blood flow will be assessed using Doppler ultrasonography, and gastric emptying will be evaluated by ultrasonography, from before meal ingestion to 180 minutes postprandially. Blood glucose, insulin, and free fatty acid levels will be measured at regular intervals before and after the meal. Diet-induced thermogenesis will be assessed by indirect calorimetry.
Interventions/Control_2
Ten healthy adults will consume a 400-kcal liquid meal (two bottles of Meibalance Mini) in the evening (18:30). Superior mesenteric artery blood flow will be assessed using Doppler ultrasonography, and gastric emptying will be evaluated by ultrasonography, from before meal ingestion to 180 minutes postprandially. Blood glucose, insulin, and free fatty acid levels will be measured at regular intervals before and after the meal. Diet-induced thermogenesis will be assessed by indirect calorimetry.
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
| 18 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Aged 18 to 59 years
2.Not taking any medications or dietary supplements
3.Free from any medical or surgical diseases
4.Non-smokers
5.Not participating in any other research studies during the study period (confirmed by direct verbal inquiry at the time of study explanation)
6.Able to consume the meals provided in the study
7.Having a regular menstrual cycle
Key exclusion criteria
1.Aged under 18 years or 60 years and older
2.Taking any medications or dietary supplements
3.Having any medical or surgical diseases
4.Current smokers
5.Planning to participate in, or currently participating in, other research studies during the study period
6.Unable to consume the meals provided in the study due to food allergies
7.Pregnant, planning to become pregnant during the study period, or within one year postpartum
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Kashima |
Organization
Prefectural University of Hiroshima
Division name
Department of Health Sciences
Zip code
7348558
Address
1-1-71 Ujina-higashi, Minami-ku, Hiroshima
TEL
082-251-9806
h-kashima@pu-hiroshima.ac.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Kashima |
Organization
Prefectural University of Hiroshima
Division name
Department of Health Sciences
Zip code
7348558
Address
1-1-71 Ujina-higashi, Minami-ku, Hiroshima
TEL
0822519806
Homepage URL
h-kashima@pu-hiroshima.ac.jp
Sponsor or person
Institute
Prefectural University of Hiroshima
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Prefectural University of Hiroshima
Address
1-1-71 Ujina-higashi, Minami-ku, Hiroshima
Tel
0822519534
kikaku2@pu-hiroshima.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 19 | 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 | 04 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 04 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | 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 | 01 | Month | 19 | Day |
Last modified on
| 2026 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069100
