UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053105 |
|---|---|
| Receipt number | R000060503 |
| Scientific Title | Evaluation of second meal effect by food intake. |
| Date of disclosure of the study information | 2025/03/01 |
| Last modified on | 2025/06/17 17:30:52 |
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Basic information
Public title
Evaluation of second meal effect by snack intake
Acronym
Evaluation of second meal effect by snack intake
Scientific Title
Evaluation of second meal effect by food intake.
Scientific Title:Acronym
Evaluation of second meal effect by food intake.
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of second meal effect by snack intake
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood glucose level after dinner intake
Key secondary outcomes
Blood glucose level after snack intake,GLP-1 value (before snack intake, before dinner intake),VAS questionnaire (feeling of fullness).
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
5
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test1
Lunch:Consume commercially available frozen pasta, two commercially available rolls, and 340ml of water.
Snack:Intake of test food 1
Dinner:1 serving of commercially available frozen hamburger set meal and rice 200g, and 340ml of water.
*Blood glucose levels are monitored until 2 hours after eating lunch and dinner.
*Wash-out period: 1 day /between test 1 and test 2
Interventions/Control_2
Test2
Lunch:Consume commercially available frozen pasta, two commercially available rolls, and 340ml of water.
Snack:Intake of test food 2
Dinner:1 serving of commercially available frozen hamburger set meal and rice 200g, and 340ml of water.
*Blood glucose levels are monitored until 2 hours after eating lunch and dinner.
*Wash-out period: 1 day /between test 2 and test 3
Interventions/Control_3
Test3
Lunch:Consume commercially available frozen pasta, two commercially available rolls, and 340ml of water.
Snack:Intake of test food 3
Dinner:1 serving of commercially available frozen hamburger set meal and rice 200g, and 340ml of water.
*Blood glucose levels are monitored until 2 hours after eating lunch and dinner.
*Wash-out period: 1 day /between test 3 and test 4
Interventions/Control_4
Test4
Lunch:Consume commercially available frozen pasta, two commercially available rolls, and 340ml of water.
Snack:Intake of test food 4
Dinner:1 serving of commercially available frozen hamburger set meal and rice 200g, and 340ml of water.
*Blood glucose levels are monitored until 2 hours after eating lunch and dinner.
*Wash-out period: 1 day /between test 4 and test 5
Interventions/Control_5
Test5
Lunch:Consume commercially available frozen pasta, two commercially available rolls, and 340ml of water.
Snack:Intake of test food 5
Dinner:1 serving of commercially available frozen hamburger set meal and rice 200g, and 340ml of water.
*Blood glucose levels are monitored until 2 hours after eating lunch and dinner.
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Japanese male and female between 20 and 59 years of age.
2. Those whose fasting blood glucose level has been confirmed to be 70 to 109 mg/dl or less
3. Written informed is required.
Key exclusion criteria
1. Subjects who are allergic to the test food's products and Specified meals
2. Patients under treatment, or on medication
3. Subjects who are pregnant, lactating, or planning to become pregnant during this trial
4. Subjects taking antidiabetic drug or health foods that claim to affect blood sugar levels
5. Subjects in ohther clinical trial
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yasuaki |
| Middle name | |
| Last name | Nakanishi |
Organization
Ezaki Glico Co., Ltd.
Division name
Nutritious Confectionery and Supplement Business Division
Zip code
5558502
Address
4-6-5 Utajima, Nishi-Yodogawa-ku, Osaka, Japan
TEL
08085191271
yasuaki.nakanishi@glico.com
Public contact
Name of contact person
| 1st name | Shinsuke |
| Middle name | |
| Last name | Kise |
Organization
Ezaki Glico Co., Ltd.
Division name
Nutritious Confectionery and Supplement Business Division
Zip code
5558502
Address
4-6-5 Utajima, Nishi-Yodogawa-ku, Osaka
TEL
08083006744
Homepage URL
shinsuke.kise@glico.com
Sponsor or person
Institute
Ezaki Glico Co., Ltd.
Institute
Department
Personal name
Shinsuke.Kise
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
Ethics Review Committees of SHIBA-PALACE Clinic
Address
1-9-10, Hamamatsucho, Minato-ku, Tokyo
Tel
0354081599
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
| 2025 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Not set
Publication of results
Unpublished
Result
URL related to results and publications
Not set
Number of participants that the trial has enrolled
15
Results
Results not published
Results date posted
| 2025 | Year | 06 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Unpublished
Participant flow
Unpublished
Adverse events
Unpublished
Outcome measures
Unpublished
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2023 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 25 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 25 | Day |
Date trial data considered complete
| 2024 | Year | 02 | Month | 02 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 14 | Day |
Last modified on
| 2025 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060503
| Research Plan | |
|---|---|
| Registered date | File name |
| 2025/12/15 | 01_147475-30648：試験計画書（第1版）_20231127（IRB済）.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2025/12/15 | 江崎グリコ株式会社御中147475-30648：報告書類.zip |
| Research case data | |
|---|---|
| Registered date | File name |
| 2025/12/15 | 江崎グリコ株式会社御中147475-30648：報告書類.zip |
Single case data URL
Value
https://center6.umin.ac.jp/ice/60503
