UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062951 |
|---|---|
| Receipt number | R000072071 |
| Scientific Title | Differential effects of snack modification on postprandial glycemia after dinner: An intervention study |
| Date of disclosure of the study information | 2026/09/16 |
| Last modified on | 2026/09/16 14:24:41 |
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Basic information
Public title
Effects of snack modification on post-dinner blood glucose: An intervention study
Acronym
Snack modification and post-dinner glucose study
Scientific Title
Differential effects of snack modification on postprandial glycemia after dinner: An intervention study
Scientific Title:Acronym
Snack modification and post-dinner glycemia study
Region
| Japan |
Condition
Condition
healthy subject
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We previously found that skipping lunch worsened the glycemic response after dinner and was accompanied by lower circulating bile acid and GLP-1 concentrations.
We therefore hypothesized that consuming snacks containing nutrients such as fat and protein, which may stimulate bile acid-related signaling and GLP-1 secretion, could attenuate the worsening of the post-dinner glycemic response induced by lunch skipping.
Accordingly, this study aims to determine whether snacks with different nutrient compositions consumed after skipping lunch can attenuate the worsening of the post-dinner glycemic response.
Basic objectives2
Others
Basic objectives -Others
Exmine whether consuming snacks after lunch skipping affects blood glucose variability.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Post-dinner incremental area under the glucose curve (iAUC) measured using an intermittently scanned continuous glucose monitoring (isCGM) system.
Key secondary outcomes
Glucose level (continuous, peak, nadir) from isCGM system
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
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
On the first day, participants undergo anthropometric measurements and body composition assessment and complete a self-administered questionnaire. Participants wear an intermittently scanned continuous glucose monitoring (isCGM) device on the upper arm for 10 days from the first day of the study.
During the study period, meal times are fixed at 7:00 for breakfast, 12:00 for lunch, 15:00 for a snack, and 18:00 for dinner. Participants are allowed to consume only water or non-sugar tea as beverages, and all meals are provided by the researchers. Participants record the time of each meal throughout the intervention period.
On days 3, 5, 7, and 9, participants undergo the randomized intervention conditions.
Intervention 1: Lunch consumption (control)
Interventions/Control_2
Lunch skipping
Interventions/Control_3
Lunch skipping followed by consumption of a snack (30 mL of flaxseed oil)
Interventions/Control_4
Lunch skipping, following eating snacks (100 grams of steamed chicken breast)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Men and women aged 18 years or older with a BMI of 18.5 or more and less than 25 kg/m2 and no personal history of diabetes or family history of diabetes in first- or second-degree relatives.
Key exclusion criteria
1) Pregnant or lactating women
2) Current smokers
3) Individuals who habitually skip meals
4) Individuals with food allergies, including a history of allergy to any of the 29 specified allergenic foods, flaxseed oil, or similar products
5) Individuals taking medications for diabetes, dyslipidemia, hypertension, or hyperuricemia
6) Individuals deemed unsuitable for participation in the study by the principal investigator
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Shimba |
Organization
University of Shizuoka
Division name
School of Food and Nutritional Sciences
Zip code
422-8526
Address
52-1 Yada, Suruga-ku, Shizuoka-shi, Shizuoka, Japan
TEL
054-264-5561
shokuji@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Shimba |
Organization
University of Shizuoka
Division name
School of Food and Nutritional Sciences
Zip code
422-8526
Address
52-1 Yada, Suruga-ku, Shizuoka-shi, Shizuoka, Japan
TEL
054-264-5561
Homepage URL
shokuji@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
University of Shizuoka
Institute
Department
Personal name
Funding Source
Organization
Urakami Foundation for Food and Food Culture Promotion
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
JSPS KAKENHI
IRB Contact (For public release)
Organization
Research Ethics Committee of the University of Shizuoka
Address
Industry-University Cooperation Office, 52-1 Yada, Suruga-ku, Shizuoka-shi, Shizuoka, Japan
Tel
054-264-5124
renkei8@u-shizuoka-ken.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
静岡県立大学臨床研究施設（静岡県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 08 | Month | 17 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2028 | Year | 03 | 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 | 09 | Month | 16 | Day |
Last modified on
| 2026 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072071
